COVID-19 Updates

What have you been doing since you left the US Public Health Service?

RADM Boris D. Lushniak, MD, MPH. I retired in 2015 and spent a year at the Uniformed Services University for the Health Sciences in Bethesda, Maryland as the Chair of Preventive Medicine and Biostatistics before I took the opportunity to become the Dean of the School of Public Health at the University of Maryland in College Park. I was very intrigued with that position. It’s a large and young school of public health—just 13 years since its inception. And it functions at both the undergraduate and graduate school levels. We have 2,400 undergraduates in 4 different degree paths. The intriguing part of this is the ability to influence a young person’s educational pathway, and for them to look at all the opportunities in public health, and to focus on a mission, which falls into the mission of the US Public Health Service (PHS) Commissioned Corps: Protect, promote and advance the health and safety of our nation.

It has been a very intriguing transition; I have been the Dean there for 3 years. Who would have predicted that things would change drastically in that time, both at the academic level (ie, moving a school from being a normal college environment to an online environment) and now moving into the realm of preparing for the near future of that university in terms of a potential reopening. It is using all of my public health experiences and putting it at that culmination point, which is my community of 52,000 people—40,000 students at the University in College Park, and 12,000 faculty and staff members.

We are responsible for making sure that the return is as safe as possible. With so many unknowns in the world of COVID-19 and so many unpredictable components, it is quite an undertaking to be able to determine for that community of 52,000 whether it’s time to return, and under what circumstances do we return.

In addition, we’re part of a larger community. The University of Maryland in College Park is in Prince George’s County, which is the epicenter of disease and death in Maryland. The School of Public Health is working closely with county authorities. Some of our students are now contact tracers. It’s been interesting to see our faculty, staff, and students standing up as a volunteer support structure for Public Health.

We have incredible research going on at the school. One of my prime research physicians, Don Milton, MD, DrPH, has been studying the transmission of influenza. Now his work is priming on not just influenza, but also COVID-19. Our hope is to establish a community that will be safe and healthy for everyone, and so it’s been an incredible amount of work.

How would you describe the federal/ local public health cooperation?

RADM Lushniak. First and foremost, we have seen a major issue in terms of state and local response to the COVID-19 pandemic. I have to congratulate the state and the local officials for doing as best as they can under the strained circumstances that they’re in.

The first strained circumstance is that local and state health departments have lost nearly a quarter of their workforce: 50,000 jobs across the country since the recession of 2008. Part of the answer why it’s been such a struggle is that our nation as a whole hasn’t looked at public health and hasn’t looked at prevention as a key component of how our country works. We have seen a lack of support at the state and the local level, the shedding of jobs, and the lack of foresight in terms of saying that prevention works and public health is important for our cities, states, regions, and the nation. We need to reemphasize that in terms of public health.

In the State of Maryland, in general, the counties are doing as best as they can under the circumstances. They certainly started out with trying to do as much testing as possible. Testing is a critical component to this response, and obviously, we have a situation nationwide with the testing still trying to be put online to the extent that it needs to be. We need to be able to test more and more individuals to be able to determine the people who are positive. The curve ball that COVID-19 threw us is that 25 to 50% of individuals who may have a positive test may be asymptomatic. So, this isn’t simple. It’s not a matter of just saying, “Okay, you’re sick. You may then have it.” It may be: “Hey, you’re feeling healthy, you still may have it.”

But just as important as testing is what you do with those individuals who are tested. You need to have health departments turning to these individuals and providing them directions of what needs to be done. If one is COVID-19-positive, one goes into isolation for at least 14 days. And if ill, they need to be connected with a medical care system. That’s an important part of the state and local response is making sure the individuals are properly directed to the right pathway.

In addition, contact tracing is critical. The way we’re going to fight COVID-19 is the ability for us to go out there and determine if you are a positive, who did you come in contact with, and did you potentially spread this to others? You need to direct individuals who may have been in contact with the person who is now COVID- 19-positive, saying “You may have to quarantine yourself, watch out for symptoms, and you have to be really careful in the meantime.”

State and local officials took up the burden of making decisions in terms of communicating the directions given to the population. Is stay at home required? Is it the closure of businesses? Is it the wearing of masks? Certainly, the issue of physical distancing plays a role.

All that was implemented at the state and local level. Under the circumstances, it has been done as well as possible, but that now reflects on the issue of the federal response. And the federal response, I’ll admit, has been less than I had hoped for on several realms.

Number one, coordination and direction from the federal level has been rather piecemeal. State and local officials, I think, were waiting for further directions. What did federal officials think; what did they want us to do? State and local officials want independence to implement things, but what’s the right answer? I think this has been not handled well at the highest levels of the US government.

Secondly, obviously, there was an issue with testing, and the responsibility here lays with the Centers of Disease Control and Prevention (CDC), which had problems from the get-go with setting up their testing caches and getting them out. We’re still catching up from there. Now it’s unfolding that the tie in between the federal government and the private sector and academic centers are at least making some headway on that testing front.

Third, people rely on the federal officials not only for action but also for communication. It really boils down to: Who’s in charge, who’s telling me the information that I need to know, who’s honest with me and telling me what they don’t know, and who has the insight to say, “Here’s how we’re going to find out the things that we don’t know?” Who’s there empathizing with the population?

The reality is there’s been a mismatch between the communication channels for the federal government and getting down not just to the state and locals but, also, to the general population in this country.

How would you characterize the US Public Health Service Response?

RADM Lushniak. I’ll first start off with kudos and congratulations to the Commissioned Corps of the PHS for their response to date. I think the latest numbers that ADM Brett Giroir, MD, Assistant Secretary of Health, told Congress in May, was that at the time more than 3,100 of the 6,100 current officers at the PHS have been deployed over the last several months. The reality is that the Commissioned Corps is out there doing service to our nation and to the world. PHS teams were deployed initially to Japan and the Diamond Princess cruise ship. The Corps been out there internationally.

Nationally, the Corps was at the Javits Center in New York assisting in setting up that medical response. They have been assisting at the military bases initially where some of the individuals who were coming in from China and other places were being held in quarantine. They have been assisting with investigations at nursing homes across the country and meat packing plants where there have been outbreaks occurring. The Commissioned Corps has been out there, so that’s the good news.

The bad news is that the Corps is a small uniformed service. The reality is nobody still is seeing the Corps or knows about the Corps as they’re out there doing their thing. It was very nice that ADM Giroir put a plug in for them in his recent congressional testimony. That’s great that our leadership is out there acknowledging the Corps. But to a large extent, I still have an issue with the Commissioned Corps being an underfunded uniformed service of this country. The Commissioned Corps is the only uniformed service in the world whose only mission is public health. But, lack of support reflects the idea of the lack of importance that public health plays in the minds of policy makers.

To a large extent, we have had no dollars in the Corps recently for training of officers to prepare for this. For 10 years we’ve waited for a Ready Reserve to be set up. The Ready Reserve component was part of the Affordable Care Act. I was in the office of the Surgeon General as we were told to ramp this up. Now 10 years later, in the midst of this COVID-19 pandemic, Congress finally has passed legislation that sets a pathway for a Ready Reserve.

Why is the Ready Reserve important? In essence, we have incredible public health professionals out there in the civilian ranks who would be willing to assist the Commissioned Corps in their mission, either to backfill critical positions where Corps officers are currently stationed and need to be deployed, or as a Ready Reserve that’s ready to deploy itself. All this is happening right now. I hope for better days, and I hope this COVID-19 pandemic will wake our nation up to the need of a Public Health Service Commissioned Corps, a uniformed service, that's out there doing good.

What lessons are we learning about public health in this pandemic?

RADM Lushniak. We’ve just developed a new space force, the 8th uniformed US service. In reality they are talking about tens of thousands of people assigned to it. Excuse me if I’m going to be assertive. I’m a big fan of space exploration. I realize that space is the final frontier and that perhaps we have to be able to defend our country in that regard. But we’re already saying that space is worth investing in. Where is the wisdom that we’re not investing in battling on this planet against emerging threats like COVID-19? And why is it that to this date the Commissioned Corps of the Public Health Service does not have its own budget; does not have a line item anywhere; does not have money directed for training; and, in essence, only serves because its officers are stationed at other agencies who pay for these officers? It’s a personnel system and not really treated as a key and critical uniformed service of this country. That’s point number one in terms of lessons learned and what needs to be done.

In addition, it’s not just the people in uniform who serve at the federal level, civilians serve as well. These civilians work at the CDC, at the US Food and Drug Administration, at the National Institute of Health, at the Indian Health Service, and at many, many other agencies throughout the US government. Within those realms, we need to show support of those federal practitioners who are working very diligently and in a devoted fashion to fight this pandemic as well. Part of it is the moral support to recognize that there are multiple fronts to fighting this pandemic and the federal practitioner who is working out there, is a key component to this.

I don’t want everything to be money, money, money, but the fact is that CDC’s budget has been decreasing over the years. How are we supposed to set up the laboratories, how are we supposed to demand the high level of expertise when, in fact, everything has to be done on a shoestring?

Finally, we notice public health in the midst of a crisis, but public health matters each and every day. The idea that the pandemic certainly brings to light what needs to get done, but without a pandemic, what do we have? We still have cigarette smoking, the number 1 killer in this country. That’s a public health issue. We have cardiovascular diseases as an extreme killer in this country. That’s a public health issue. We have diabetes mellitus that is rampant. We have substance abuse, including the opioid epidemic. Those are public health issues. We have hypertension, we have overweight and obesity. Those are all public health issues that public health battles each and every day without the recognition.

What we need is a major shift in the philosophy of this country to really take the health and wellness of our society as a key component of how you’ll raise that on to a pedestal—the idea that health and wellness is critical to the functioning of this country.

How have recent public health emergencies influenced the Commissioned Corps?

RADM Lushniak. The key feature is that the Public Health Service Commissioned Corps has been growing in its mission over the years. The pre-9/11 Commissioned Corps, was a different life. The post-9/11 world is the first time that the Commissioned Corps really fell into this idea of being America’s public health responders. I think that we ramped it up; we started out strong.

This was shown not only in the World Trade Center and the 9/11 disasters that occurred, but in the anthrax scenario that unfolded shortly afterwards. We saw it further continue in Hurricane Katrina and the multiple hurricane responses.

Then the Ebola response, in my last year of serving in uniform, was another action of both the civilian sector of federal responders as well as the uniformed sector. The beauty of that in terms of what we learned from Ebola was that coordination is key. That was the first time that the PHS worked so closely with the US Department of Defense and our sister services to basically have an international mission unfold with that level of coordination.

We can use those changes that have gone on, the metamorphoses that have happened over the years, as a jumping off point, but they need to be fulfilled with further growth and support of the Commissioned Corps of the US Public Health Service. The numbers are the lowest they’ve been in recent times in terms of active duty officers. That’s not a good thing. As the mission expands, the idea of recruiting and retaining remains a problem. We have to deal with it.

Was your interest in taking the position at the University of Maryland in part to help build the future of public health?

RADM Lushniak. Certainly, I was so excited to be at the University of Maryland College Park exactly for that reason. The undergraduates are coming in from high school and their eyes are wide open. Two things are important at that stage. One is to teach them about the beauty of public health. That it’s a bold and noble mission. As I always tell our students, it’s about the 3 Ps: Promoting health and wellbeing, preventing disease and injury, and prolonging a high quality of life.

When you put all those things together, that’s an incredible mission. I want to tell them at that young age, “Be a part of this, figure out where you fit in.” But it’s not for everyone. I tell my students that one of the major attributes that I need to see in a student is optimism. Public health does not deal well with pessimism. If your character is pessimistic, I actually dissuade you from becoming a public health person because there are a lot of barriers in this incredible bold and noble mission, and optimism needs to be a key feature that keeps us all going.

Next is the realization that there’s so many different public health issues in our world, so many different problems to deal with. I mentioned some of them previously in terms of the public health issues we see each and every day.

Let me talk about one that’s, in particular, shining through in the midst of COVID-19, but also shines through each and every day. That’s the issue of health equity in our communities. A young person, who usually comes in and wants to help their community, needs to realize that part of the battle of public health is to make sure that we deal with the disparities that exist. We must make health equity a key component of our jobs. We are here to serve others.

There’s a saying at the University of Maryland College Park that we’re a “Do good university.” I would say that public health is a do-good profession. It is about compassion, it’s about love, it’s about caring. Those are the types of people that I try to bring into the school, and I try to mentor and support.

What have you been doing since you left the US Public Health Service?

RADM Boris D. Lushniak, MD, MPH. I retired in 2015 and spent a year at the Uniformed Services University for the Health Sciences in Bethesda, Maryland as the Chair of Preventive Medicine and Biostatistics before I took the opportunity to become the Dean of the School of Public Health at the University of Maryland in College Park. I was very intrigued with that position. It’s a large and young school of public health—just 13 years since its inception. And it functions at both the undergraduate and graduate school levels. We have 2,400 undergraduates in 4 different degree paths. The intriguing part of this is the ability to influence a young person’s educational pathway, and for them to look at all the opportunities in public health, and to focus on a mission, which falls into the mission of the US Public Health Service (PHS) Commissioned Corps: Protect, promote and advance the health and safety of our nation.

It has been a very intriguing transition; I have been the Dean there for 3 years. Who would have predicted that things would change drastically in that time, both at the academic level (ie, moving a school from being a normal college environment to an online environment) and now moving into the realm of preparing for the near future of that university in terms of a potential reopening. It is using all of my public health experiences and putting it at that culmination point, which is my community of 52,000 people—40,000 students at the University in College Park, and 12,000 faculty and staff members.

We are responsible for making sure that the return is as safe as possible. With so many unknowns in the world of COVID-19 and so many unpredictable components, it is quite an undertaking to be able to determine for that community of 52,000 whether it’s time to return, and under what circumstances do we return.

In addition, we’re part of a larger community. The University of Maryland in College Park is in Prince George’s County, which is the epicenter of disease and death in Maryland. The School of Public Health is working closely with county authorities. Some of our students are now contact tracers. It’s been interesting to see our faculty, staff, and students standing up as a volunteer support structure for Public Health.

We have incredible research going on at the school. One of my prime research physicians, Don Milton, MD, DrPH, has been studying the transmission of influenza. Now his work is priming on not just influenza, but also COVID-19. Our hope is to establish a community that will be safe and healthy for everyone, and so it’s been an incredible amount of work.

How would you describe the federal/ local public health cooperation?

RADM Lushniak. First and foremost, we have seen a major issue in terms of state and local response to the COVID-19 pandemic. I have to congratulate the state and the local officials for doing as best as they can under the strained circumstances that they’re in.

The first strained circumstance is that local and state health departments have lost nearly a quarter of their workforce: 50,000 jobs across the country since the recession of 2008. Part of the answer why it’s been such a struggle is that our nation as a whole hasn’t looked at public health and hasn’t looked at prevention as a key component of how our country works. We have seen a lack of support at the state and the local level, the shedding of jobs, and the lack of foresight in terms of saying that prevention works and public health is important for our cities, states, regions, and the nation. We need to reemphasize that in terms of public health.

In the State of Maryland, in general, the counties are doing as best as they can under the circumstances. They certainly started out with trying to do as much testing as possible. Testing is a critical component to this response, and obviously, we have a situation nationwide with the testing still trying to be put online to the extent that it needs to be. We need to be able to test more and more individuals to be able to determine the people who are positive. The curve ball that COVID-19 threw us is that 25 to 50% of individuals who may have a positive test may be asymptomatic. So, this isn’t simple. It’s not a matter of just saying, “Okay, you’re sick. You may then have it.” It may be: “Hey, you’re feeling healthy, you still may have it.”

But just as important as testing is what you do with those individuals who are tested. You need to have health departments turning to these individuals and providing them directions of what needs to be done. If one is COVID-19-positive, one goes into isolation for at least 14 days. And if ill, they need to be connected with a medical care system. That’s an important part of the state and local response is making sure the individuals are properly directed to the right pathway.

In addition, contact tracing is critical. The way we’re going to fight COVID-19 is the ability for us to go out there and determine if you are a positive, who did you come in contact with, and did you potentially spread this to others? You need to direct individuals who may have been in contact with the person who is now COVID- 19-positive, saying “You may have to quarantine yourself, watch out for symptoms, and you have to be really careful in the meantime.”

State and local officials took up the burden of making decisions in terms of communicating the directions given to the population. Is stay at home required? Is it the closure of businesses? Is it the wearing of masks? Certainly, the issue of physical distancing plays a role.

All that was implemented at the state and local level. Under the circumstances, it has been done as well as possible, but that now reflects on the issue of the federal response. And the federal response, I’ll admit, has been less than I had hoped for on several realms.

Number one, coordination and direction from the federal level has been rather piecemeal. State and local officials, I think, were waiting for further directions. What did federal officials think; what did they want us to do? State and local officials want independence to implement things, but what’s the right answer? I think this has been not handled well at the highest levels of the US government.

Secondly, obviously, there was an issue with testing, and the responsibility here lays with the Centers of Disease Control and Prevention (CDC), which had problems from the get-go with setting up their testing caches and getting them out. We’re still catching up from there. Now it’s unfolding that the tie in between the federal government and the private sector and academic centers are at least making some headway on that testing front.

Third, people rely on the federal officials not only for action but also for communication. It really boils down to: Who’s in charge, who’s telling me the information that I need to know, who’s honest with me and telling me what they don’t know, and who has the insight to say, “Here’s how we’re going to find out the things that we don’t know?” Who’s there empathizing with the population?

The reality is there’s been a mismatch between the communication channels for the federal government and getting down not just to the state and locals but, also, to the general population in this country.

How would you characterize the US Public Health Service Response?

RADM Lushniak. I’ll first start off with kudos and congratulations to the Commissioned Corps of the PHS for their response to date. I think the latest numbers that ADM Brett Giroir, MD, Assistant Secretary of Health, told Congress in May, was that at the time more than 3,100 of the 6,100 current officers at the PHS have been deployed over the last several months. The reality is that the Commissioned Corps is out there doing service to our nation and to the world. PHS teams were deployed initially to Japan and the Diamond Princess cruise ship. The Corps been out there internationally.

Nationally, the Corps was at the Javits Center in New York assisting in setting up that medical response. They have been assisting at the military bases initially where some of the individuals who were coming in from China and other places were being held in quarantine. They have been assisting with investigations at nursing homes across the country and meat packing plants where there have been outbreaks occurring. The Commissioned Corps has been out there, so that’s the good news.

The bad news is that the Corps is a small uniformed service. The reality is nobody still is seeing the Corps or knows about the Corps as they’re out there doing their thing. It was very nice that ADM Giroir put a plug in for them in his recent congressional testimony. That’s great that our leadership is out there acknowledging the Corps. But to a large extent, I still have an issue with the Commissioned Corps being an underfunded uniformed service of this country. The Commissioned Corps is the only uniformed service in the world whose only mission is public health. But, lack of support reflects the idea of the lack of importance that public health plays in the minds of policy makers.

To a large extent, we have had no dollars in the Corps recently for training of officers to prepare for this. For 10 years we’ve waited for a Ready Reserve to be set up. The Ready Reserve component was part of the Affordable Care Act. I was in the office of the Surgeon General as we were told to ramp this up. Now 10 years later, in the midst of this COVID-19 pandemic, Congress finally has passed legislation that sets a pathway for a Ready Reserve.

Why is the Ready Reserve important? In essence, we have incredible public health professionals out there in the civilian ranks who would be willing to assist the Commissioned Corps in their mission, either to backfill critical positions where Corps officers are currently stationed and need to be deployed, or as a Ready Reserve that’s ready to deploy itself. All this is happening right now. I hope for better days, and I hope this COVID-19 pandemic will wake our nation up to the need of a Public Health Service Commissioned Corps, a uniformed service, that's out there doing good.

What lessons are we learning about public health in this pandemic?

RADM Lushniak. We’ve just developed a new space force, the 8th uniformed US service. In reality they are talking about tens of thousands of people assigned to it. Excuse me if I’m going to be assertive. I’m a big fan of space exploration. I realize that space is the final frontier and that perhaps we have to be able to defend our country in that regard. But we’re already saying that space is worth investing in. Where is the wisdom that we’re not investing in battling on this planet against emerging threats like COVID-19? And why is it that to this date the Commissioned Corps of the Public Health Service does not have its own budget; does not have a line item anywhere; does not have money directed for training; and, in essence, only serves because its officers are stationed at other agencies who pay for these officers? It’s a personnel system and not really treated as a key and critical uniformed service of this country. That’s point number one in terms of lessons learned and what needs to be done.

In addition, it’s not just the people in uniform who serve at the federal level, civilians serve as well. These civilians work at the CDC, at the US Food and Drug Administration, at the National Institute of Health, at the Indian Health Service, and at many, many other agencies throughout the US government. Within those realms, we need to show support of those federal practitioners who are working very diligently and in a devoted fashion to fight this pandemic as well. Part of it is the moral support to recognize that there are multiple fronts to fighting this pandemic and the federal practitioner who is working out there, is a key component to this.

I don’t want everything to be money, money, money, but the fact is that CDC’s budget has been decreasing over the years. How are we supposed to set up the laboratories, how are we supposed to demand the high level of expertise when, in fact, everything has to be done on a shoestring?

Finally, we notice public health in the midst of a crisis, but public health matters each and every day. The idea that the pandemic certainly brings to light what needs to get done, but without a pandemic, what do we have? We still have cigarette smoking, the number 1 killer in this country. That’s a public health issue. We have cardiovascular diseases as an extreme killer in this country. That’s a public health issue. We have diabetes mellitus that is rampant. We have substance abuse, including the opioid epidemic. Those are public health issues. We have hypertension, we have overweight and obesity. Those are all public health issues that public health battles each and every day without the recognition.

What we need is a major shift in the philosophy of this country to really take the health and wellness of our society as a key component of how you’ll raise that on to a pedestal—the idea that health and wellness is critical to the functioning of this country.

How have recent public health emergencies influenced the Commissioned Corps?

RADM Lushniak. The key feature is that the Public Health Service Commissioned Corps has been growing in its mission over the years. The pre-9/11 Commissioned Corps, was a different life. The post-9/11 world is the first time that the Commissioned Corps really fell into this idea of being America’s public health responders. I think that we ramped it up; we started out strong.

This was shown not only in the World Trade Center and the 9/11 disasters that occurred, but in the anthrax scenario that unfolded shortly afterwards. We saw it further continue in Hurricane Katrina and the multiple hurricane responses.

Then the Ebola response, in my last year of serving in uniform, was another action of both the civilian sector of federal responders as well as the uniformed sector. The beauty of that in terms of what we learned from Ebola was that coordination is key. That was the first time that the PHS worked so closely with the US Department of Defense and our sister services to basically have an international mission unfold with that level of coordination.

We can use those changes that have gone on, the metamorphoses that have happened over the years, as a jumping off point, but they need to be fulfilled with further growth and support of the Commissioned Corps of the US Public Health Service. The numbers are the lowest they’ve been in recent times in terms of active duty officers. That’s not a good thing. As the mission expands, the idea of recruiting and retaining remains a problem. We have to deal with it.

Was your interest in taking the position at the University of Maryland in part to help build the future of public health?

RADM Lushniak. Certainly, I was so excited to be at the University of Maryland College Park exactly for that reason. The undergraduates are coming in from high school and their eyes are wide open. Two things are important at that stage. One is to teach them about the beauty of public health. That it’s a bold and noble mission. As I always tell our students, it’s about the 3 Ps: Promoting health and wellbeing, preventing disease and injury, and prolonging a high quality of life.

When you put all those things together, that’s an incredible mission. I want to tell them at that young age, “Be a part of this, figure out where you fit in.” But it’s not for everyone. I tell my students that one of the major attributes that I need to see in a student is optimism. Public health does not deal well with pessimism. If your character is pessimistic, I actually dissuade you from becoming a public health person because there are a lot of barriers in this incredible bold and noble mission, and optimism needs to be a key feature that keeps us all going.

Next is the realization that there’s so many different public health issues in our world, so many different problems to deal with. I mentioned some of them previously in terms of the public health issues we see each and every day.

Let me talk about one that’s, in particular, shining through in the midst of COVID-19, but also shines through each and every day. That’s the issue of health equity in our communities. A young person, who usually comes in and wants to help their community, needs to realize that part of the battle of public health is to make sure that we deal with the disparities that exist. We must make health equity a key component of our jobs. We are here to serve others.

There’s a saying at the University of Maryland College Park that we’re a “Do good university.” I would say that public health is a do-good profession. It is about compassion, it’s about love, it’s about caring. Those are the types of people that I try to bring into the school, and I try to mentor and support.

What have you been doing since you left the US Public Health Service?

RADM Boris D. Lushniak, MD, MPH. I retired in 2015 and spent a year at the Uniformed Services University for the Health Sciences in Bethesda, Maryland as the Chair of Preventive Medicine and Biostatistics before I took the opportunity to become the Dean of the School of Public Health at the University of Maryland in College Park. I was very intrigued with that position. It’s a large and young school of public health—just 13 years since its inception. And it functions at both the undergraduate and graduate school levels. We have 2,400 undergraduates in 4 different degree paths. The intriguing part of this is the ability to influence a young person’s educational pathway, and for them to look at all the opportunities in public health, and to focus on a mission, which falls into the mission of the US Public Health Service (PHS) Commissioned Corps: Protect, promote and advance the health and safety of our nation.

It has been a very intriguing transition; I have been the Dean there for 3 years. Who would have predicted that things would change drastically in that time, both at the academic level (ie, moving a school from being a normal college environment to an online environment) and now moving into the realm of preparing for the near future of that university in terms of a potential reopening. It is using all of my public health experiences and putting it at that culmination point, which is my community of 52,000 people—40,000 students at the University in College Park, and 12,000 faculty and staff members.

We are responsible for making sure that the return is as safe as possible. With so many unknowns in the world of COVID-19 and so many unpredictable components, it is quite an undertaking to be able to determine for that community of 52,000 whether it’s time to return, and under what circumstances do we return.

In addition, we’re part of a larger community. The University of Maryland in College Park is in Prince George’s County, which is the epicenter of disease and death in Maryland. The School of Public Health is working closely with county authorities. Some of our students are now contact tracers. It’s been interesting to see our faculty, staff, and students standing up as a volunteer support structure for Public Health.

We have incredible research going on at the school. One of my prime research physicians, Don Milton, MD, DrPH, has been studying the transmission of influenza. Now his work is priming on not just influenza, but also COVID-19. Our hope is to establish a community that will be safe and healthy for everyone, and so it’s been an incredible amount of work.

How would you describe the federal/ local public health cooperation?

RADM Lushniak. First and foremost, we have seen a major issue in terms of state and local response to the COVID-19 pandemic. I have to congratulate the state and the local officials for doing as best as they can under the strained circumstances that they’re in.

The first strained circumstance is that local and state health departments have lost nearly a quarter of their workforce: 50,000 jobs across the country since the recession of 2008. Part of the answer why it’s been such a struggle is that our nation as a whole hasn’t looked at public health and hasn’t looked at prevention as a key component of how our country works. We have seen a lack of support at the state and the local level, the shedding of jobs, and the lack of foresight in terms of saying that prevention works and public health is important for our cities, states, regions, and the nation. We need to reemphasize that in terms of public health.

In the State of Maryland, in general, the counties are doing as best as they can under the circumstances. They certainly started out with trying to do as much testing as possible. Testing is a critical component to this response, and obviously, we have a situation nationwide with the testing still trying to be put online to the extent that it needs to be. We need to be able to test more and more individuals to be able to determine the people who are positive. The curve ball that COVID-19 threw us is that 25 to 50% of individuals who may have a positive test may be asymptomatic. So, this isn’t simple. It’s not a matter of just saying, “Okay, you’re sick. You may then have it.” It may be: “Hey, you’re feeling healthy, you still may have it.”

But just as important as testing is what you do with those individuals who are tested. You need to have health departments turning to these individuals and providing them directions of what needs to be done. If one is COVID-19-positive, one goes into isolation for at least 14 days. And if ill, they need to be connected with a medical care system. That’s an important part of the state and local response is making sure the individuals are properly directed to the right pathway.

In addition, contact tracing is critical. The way we’re going to fight COVID-19 is the ability for us to go out there and determine if you are a positive, who did you come in contact with, and did you potentially spread this to others? You need to direct individuals who may have been in contact with the person who is now COVID- 19-positive, saying “You may have to quarantine yourself, watch out for symptoms, and you have to be really careful in the meantime.”

State and local officials took up the burden of making decisions in terms of communicating the directions given to the population. Is stay at home required? Is it the closure of businesses? Is it the wearing of masks? Certainly, the issue of physical distancing plays a role.

All that was implemented at the state and local level. Under the circumstances, it has been done as well as possible, but that now reflects on the issue of the federal response. And the federal response, I’ll admit, has been less than I had hoped for on several realms.

Number one, coordination and direction from the federal level has been rather piecemeal. State and local officials, I think, were waiting for further directions. What did federal officials think; what did they want us to do? State and local officials want independence to implement things, but what’s the right answer? I think this has been not handled well at the highest levels of the US government.

Secondly, obviously, there was an issue with testing, and the responsibility here lays with the Centers of Disease Control and Prevention (CDC), which had problems from the get-go with setting up their testing caches and getting them out. We’re still catching up from there. Now it’s unfolding that the tie in between the federal government and the private sector and academic centers are at least making some headway on that testing front.

Third, people rely on the federal officials not only for action but also for communication. It really boils down to: Who’s in charge, who’s telling me the information that I need to know, who’s honest with me and telling me what they don’t know, and who has the insight to say, “Here’s how we’re going to find out the things that we don’t know?” Who’s there empathizing with the population?

The reality is there’s been a mismatch between the communication channels for the federal government and getting down not just to the state and locals but, also, to the general population in this country.

How would you characterize the US Public Health Service Response?

RADM Lushniak. I’ll first start off with kudos and congratulations to the Commissioned Corps of the PHS for their response to date. I think the latest numbers that ADM Brett Giroir, MD, Assistant Secretary of Health, told Congress in May, was that at the time more than 3,100 of the 6,100 current officers at the PHS have been deployed over the last several months. The reality is that the Commissioned Corps is out there doing service to our nation and to the world. PHS teams were deployed initially to Japan and the Diamond Princess cruise ship. The Corps been out there internationally.

Nationally, the Corps was at the Javits Center in New York assisting in setting up that medical response. They have been assisting at the military bases initially where some of the individuals who were coming in from China and other places were being held in quarantine. They have been assisting with investigations at nursing homes across the country and meat packing plants where there have been outbreaks occurring. The Commissioned Corps has been out there, so that’s the good news.

The bad news is that the Corps is a small uniformed service. The reality is nobody still is seeing the Corps or knows about the Corps as they’re out there doing their thing. It was very nice that ADM Giroir put a plug in for them in his recent congressional testimony. That’s great that our leadership is out there acknowledging the Corps. But to a large extent, I still have an issue with the Commissioned Corps being an underfunded uniformed service of this country. The Commissioned Corps is the only uniformed service in the world whose only mission is public health. But, lack of support reflects the idea of the lack of importance that public health plays in the minds of policy makers.

To a large extent, we have had no dollars in the Corps recently for training of officers to prepare for this. For 10 years we’ve waited for a Ready Reserve to be set up. The Ready Reserve component was part of the Affordable Care Act. I was in the office of the Surgeon General as we were told to ramp this up. Now 10 years later, in the midst of this COVID-19 pandemic, Congress finally has passed legislation that sets a pathway for a Ready Reserve.

Why is the Ready Reserve important? In essence, we have incredible public health professionals out there in the civilian ranks who would be willing to assist the Commissioned Corps in their mission, either to backfill critical positions where Corps officers are currently stationed and need to be deployed, or as a Ready Reserve that’s ready to deploy itself. All this is happening right now. I hope for better days, and I hope this COVID-19 pandemic will wake our nation up to the need of a Public Health Service Commissioned Corps, a uniformed service, that's out there doing good.

What lessons are we learning about public health in this pandemic?

RADM Lushniak. We’ve just developed a new space force, the 8th uniformed US service. In reality they are talking about tens of thousands of people assigned to it. Excuse me if I’m going to be assertive. I’m a big fan of space exploration. I realize that space is the final frontier and that perhaps we have to be able to defend our country in that regard. But we’re already saying that space is worth investing in. Where is the wisdom that we’re not investing in battling on this planet against emerging threats like COVID-19? And why is it that to this date the Commissioned Corps of the Public Health Service does not have its own budget; does not have a line item anywhere; does not have money directed for training; and, in essence, only serves because its officers are stationed at other agencies who pay for these officers? It’s a personnel system and not really treated as a key and critical uniformed service of this country. That’s point number one in terms of lessons learned and what needs to be done.

In addition, it’s not just the people in uniform who serve at the federal level, civilians serve as well. These civilians work at the CDC, at the US Food and Drug Administration, at the National Institute of Health, at the Indian Health Service, and at many, many other agencies throughout the US government. Within those realms, we need to show support of those federal practitioners who are working very diligently and in a devoted fashion to fight this pandemic as well. Part of it is the moral support to recognize that there are multiple fronts to fighting this pandemic and the federal practitioner who is working out there, is a key component to this.

I don’t want everything to be money, money, money, but the fact is that CDC’s budget has been decreasing over the years. How are we supposed to set up the laboratories, how are we supposed to demand the high level of expertise when, in fact, everything has to be done on a shoestring?

Finally, we notice public health in the midst of a crisis, but public health matters each and every day. The idea that the pandemic certainly brings to light what needs to get done, but without a pandemic, what do we have? We still have cigarette smoking, the number 1 killer in this country. That’s a public health issue. We have cardiovascular diseases as an extreme killer in this country. That’s a public health issue. We have diabetes mellitus that is rampant. We have substance abuse, including the opioid epidemic. Those are public health issues. We have hypertension, we have overweight and obesity. Those are all public health issues that public health battles each and every day without the recognition.

What we need is a major shift in the philosophy of this country to really take the health and wellness of our society as a key component of how you’ll raise that on to a pedestal—the idea that health and wellness is critical to the functioning of this country.

How have recent public health emergencies influenced the Commissioned Corps?

RADM Lushniak. The key feature is that the Public Health Service Commissioned Corps has been growing in its mission over the years. The pre-9/11 Commissioned Corps, was a different life. The post-9/11 world is the first time that the Commissioned Corps really fell into this idea of being America’s public health responders. I think that we ramped it up; we started out strong.

This was shown not only in the World Trade Center and the 9/11 disasters that occurred, but in the anthrax scenario that unfolded shortly afterwards. We saw it further continue in Hurricane Katrina and the multiple hurricane responses.

Then the Ebola response, in my last year of serving in uniform, was another action of both the civilian sector of federal responders as well as the uniformed sector. The beauty of that in terms of what we learned from Ebola was that coordination is key. That was the first time that the PHS worked so closely with the US Department of Defense and our sister services to basically have an international mission unfold with that level of coordination.

We can use those changes that have gone on, the metamorphoses that have happened over the years, as a jumping off point, but they need to be fulfilled with further growth and support of the Commissioned Corps of the US Public Health Service. The numbers are the lowest they’ve been in recent times in terms of active duty officers. That’s not a good thing. As the mission expands, the idea of recruiting and retaining remains a problem. We have to deal with it.

Was your interest in taking the position at the University of Maryland in part to help build the future of public health?

RADM Lushniak. Certainly, I was so excited to be at the University of Maryland College Park exactly for that reason. The undergraduates are coming in from high school and their eyes are wide open. Two things are important at that stage. One is to teach them about the beauty of public health. That it’s a bold and noble mission. As I always tell our students, it’s about the 3 Ps: Promoting health and wellbeing, preventing disease and injury, and prolonging a high quality of life.

When you put all those things together, that’s an incredible mission. I want to tell them at that young age, “Be a part of this, figure out where you fit in.” But it’s not for everyone. I tell my students that one of the major attributes that I need to see in a student is optimism. Public health does not deal well with pessimism. If your character is pessimistic, I actually dissuade you from becoming a public health person because there are a lot of barriers in this incredible bold and noble mission, and optimism needs to be a key feature that keeps us all going.

Next is the realization that there’s so many different public health issues in our world, so many different problems to deal with. I mentioned some of them previously in terms of the public health issues we see each and every day.

Let me talk about one that’s, in particular, shining through in the midst of COVID-19, but also shines through each and every day. That’s the issue of health equity in our communities. A young person, who usually comes in and wants to help their community, needs to realize that part of the battle of public health is to make sure that we deal with the disparities that exist. We must make health equity a key component of our jobs. We are here to serve others.

There’s a saying at the University of Maryland College Park that we’re a “Do good university.” I would say that public health is a do-good profession. It is about compassion, it’s about love, it’s about caring. Those are the types of people that I try to bring into the school, and I try to mentor and support.

Finding effective treatment or a vaccine for COVID-19, the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has placed significant strains on the global health care system. The National Library of Medicine database lists > 1,800 trials that are aimed at addressing COVID-19-related health care. Already, trials developed by the US Department of Veterans Affairs (VA), US Department of Defense (DoD), and the National Institute of Allergy and Infectious Diseases have provided important data on effective treatment options. The clinical trials listed below are all open as of May 31, 2020 and have trial sites at VA and DoD facilities. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Adaptive COVID-19 Treatment Trial (ACTT)

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study will compare different investigational therapeutic agents to a control arm. ID: NCT04280705

Sponsor: National Institute of Allergy and Infectious Diseases
Contact: Central Contact (dmidclinicaltrials@niaid.nih.gov)
Locations: VA Palo Alto Health Care System, California; Naval Medical Center San Diego, California; Southeast Louisiana Veterans Health Care System, New Orleans; Walter Reed National Military Medical Center, Bethesda, Maryland; National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Bethesda, Maryland; Brooke Army Medical Center, Fort Sam Houston, Texas; Madigan Army Medical Center, Tacoma, Washington
 

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe Coronavirus Disease (COVID-19)

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 11 (NCT04292730) or Day 14 (NCT04292899).

ID: NCT04292730/NCT04292899
Sponsor: Gilead Sciences
Contact: Gilead Clinical Study Information Center (833-445-3230)
Location: James J. Peters VA Medical Center, Bronx, New York
 

Expanded Access Remdesivir (RDV; GS-5734)

The treatment of communicable Novel Coronavirus of 2019 with Remdesivir (RDV; GS-5734) also known as severe acute respiratory syndrome coronavirus 2.

ID: NCT04302766
Sponsor: US Army Medical Research and Development Command
Contact: Sandi Parriott (sandi.k.parriott.mil@mail.mil)
 

A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

ID: NCT04320615
Sponsor: Hoffmann-La Roche
Location: James J Peters VA Medical Center, Bronx, New York
 

Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation (AVoCaDO)

Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in COVID-19 subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

ID: NCT04357782
Sponsor: Hunter Holmes Mcguire VA Medical CenterContact: Brian Davis (brian.davis5@va.gov)
Location: Hunter Holmes Mcguire VA Medical Center, Richmond, Virginia

Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

This is an expanded access open-label, single-arm, multi-site protocol to provide convalescent plasma as a treatment for patients diagnosed with severe, or life-threatening COVID-19.

ID: NCT04360486
Sponsor: US Army Medical Research and Development Command
Contact: Andrew Cap (andrew.p.cap.mil@mail.mil)
 

VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL) (VA-REACH)

We propose a 3-arm randomized control trial to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among veterans in the outpatient setting.

ID: NCT04363203
Sponsor: Salomeh Keyhani
Location: San Francisco VA Health Care System, California
 

A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia (COVASTIL)

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) or UTTR1147A in combination with standard of care (SOC) compared with matching placebo in combination with SOC in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.

ID: NCT04386616
Sponsor: Genentech
Contact: Study ID Number: GA42469 (global-roche-genentech-trials@gene.com)
Location: Southeast Louisiana Veterans Health Care System, New Orleans

Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH)

The purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of veterans who are hospitalized to an acute care ward due to COVID-19.ID: NCT04397718

Sponsor: VA Office of Research and Development
Contact: Matthew B Rettig (matthew.rettig@va.gov), Nicholas Nickols (nicholas.nickols@va.gov)
Locations: VA Greater Los Angeles Healthcare System, California; VA NY Harbor Healthcare System, New York; VA Puget Sound Health Care System, Seattle, Washington
 

Adaptive COVID-19 Treatment Trial 2 (ACTT-II)

ACTT-II will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29.

ID: NCT04401579
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Contact: Central Contact (dmidclinicaltrials@niaid.nih.gov)
Locations: VA Palo Alto Health Care System, California; Naval Medical Center San Diego, California; Rocky Mountain Regional Veteran Affairs Medical Center, Aurora, Colorado; Southeast Louisiana Veterans Health Care System, New Orleans; Walter Reed National Military Medical Center, Bethesda, Maryland; National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Bethesda, Maryland; Brooke Army Medical Center, Fort Sam Houston, Texas; Madigan Army Medical Center, Tacoma, Washington

Finding effective treatment or a vaccine for COVID-19, the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has placed significant strains on the global health care system. The National Library of Medicine database lists > 1,800 trials that are aimed at addressing COVID-19-related health care. Already, trials developed by the US Department of Veterans Affairs (VA), US Department of Defense (DoD), and the National Institute of Allergy and Infectious Diseases have provided important data on effective treatment options. The clinical trials listed below are all open as of May 31, 2020 and have trial sites at VA and DoD facilities. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Adaptive COVID-19 Treatment Trial (ACTT)

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study will compare different investigational therapeutic agents to a control arm. ID: NCT04280705

Sponsor: National Institute of Allergy and Infectious Diseases
Contact: Central Contact (dmidclinicaltrials@niaid.nih.gov)
Locations: VA Palo Alto Health Care System, California; Naval Medical Center San Diego, California; Southeast Louisiana Veterans Health Care System, New Orleans; Walter Reed National Military Medical Center, Bethesda, Maryland; National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Bethesda, Maryland; Brooke Army Medical Center, Fort Sam Houston, Texas; Madigan Army Medical Center, Tacoma, Washington
 

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe Coronavirus Disease (COVID-19)

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 11 (NCT04292730) or Day 14 (NCT04292899).

ID: NCT04292730/NCT04292899
Sponsor: Gilead Sciences
Contact: Gilead Clinical Study Information Center (833-445-3230)
Location: James J. Peters VA Medical Center, Bronx, New York
 

Expanded Access Remdesivir (RDV; GS-5734)

The treatment of communicable Novel Coronavirus of 2019 with Remdesivir (RDV; GS-5734) also known as severe acute respiratory syndrome coronavirus 2.

ID: NCT04302766
Sponsor: US Army Medical Research and Development Command
Contact: Sandi Parriott (sandi.k.parriott.mil@mail.mil)
 

A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

ID: NCT04320615
Sponsor: Hoffmann-La Roche
Location: James J Peters VA Medical Center, Bronx, New York
 

Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation (AVoCaDO)

Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in COVID-19 subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

ID: NCT04357782
Sponsor: Hunter Holmes Mcguire VA Medical CenterContact: Brian Davis (brian.davis5@va.gov)
Location: Hunter Holmes Mcguire VA Medical Center, Richmond, Virginia

Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

This is an expanded access open-label, single-arm, multi-site protocol to provide convalescent plasma as a treatment for patients diagnosed with severe, or life-threatening COVID-19.

ID: NCT04360486
Sponsor: US Army Medical Research and Development Command
Contact: Andrew Cap (andrew.p.cap.mil@mail.mil)
 

VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL) (VA-REACH)

We propose a 3-arm randomized control trial to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among veterans in the outpatient setting.

ID: NCT04363203
Sponsor: Salomeh Keyhani
Location: San Francisco VA Health Care System, California
 

A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia (COVASTIL)

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) or UTTR1147A in combination with standard of care (SOC) compared with matching placebo in combination with SOC in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.

ID: NCT04386616
Sponsor: Genentech
Contact: Study ID Number: GA42469 (global-roche-genentech-trials@gene.com)
Location: Southeast Louisiana Veterans Health Care System, New Orleans

Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH)

The purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of veterans who are hospitalized to an acute care ward due to COVID-19.ID: NCT04397718

Sponsor: VA Office of Research and Development
Contact: Matthew B Rettig (matthew.rettig@va.gov), Nicholas Nickols (nicholas.nickols@va.gov)
Locations: VA Greater Los Angeles Healthcare System, California; VA NY Harbor Healthcare System, New York; VA Puget Sound Health Care System, Seattle, Washington
 

Adaptive COVID-19 Treatment Trial 2 (ACTT-II)

ACTT-II will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29.

ID: NCT04401579
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Contact: Central Contact (dmidclinicaltrials@niaid.nih.gov)
Locations: VA Palo Alto Health Care System, California; Naval Medical Center San Diego, California; Rocky Mountain Regional Veteran Affairs Medical Center, Aurora, Colorado; Southeast Louisiana Veterans Health Care System, New Orleans; Walter Reed National Military Medical Center, Bethesda, Maryland; National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Bethesda, Maryland; Brooke Army Medical Center, Fort Sam Houston, Texas; Madigan Army Medical Center, Tacoma, Washington

Finding effective treatment or a vaccine for COVID-19, the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has placed significant strains on the global health care system. The National Library of Medicine database lists > 1,800 trials that are aimed at addressing COVID-19-related health care. Already, trials developed by the US Department of Veterans Affairs (VA), US Department of Defense (DoD), and the National Institute of Allergy and Infectious Diseases have provided important data on effective treatment options. The clinical trials listed below are all open as of May 31, 2020 and have trial sites at VA and DoD facilities. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Adaptive COVID-19 Treatment Trial (ACTT)

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study will compare different investigational therapeutic agents to a control arm. ID: NCT04280705

Sponsor: National Institute of Allergy and Infectious Diseases
Contact: Central Contact (dmidclinicaltrials@niaid.nih.gov)
Locations: VA Palo Alto Health Care System, California; Naval Medical Center San Diego, California; Southeast Louisiana Veterans Health Care System, New Orleans; Walter Reed National Military Medical Center, Bethesda, Maryland; National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Bethesda, Maryland; Brooke Army Medical Center, Fort Sam Houston, Texas; Madigan Army Medical Center, Tacoma, Washington
 

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe Coronavirus Disease (COVID-19)

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 11 (NCT04292730) or Day 14 (NCT04292899).

ID: NCT04292730/NCT04292899
Sponsor: Gilead Sciences
Contact: Gilead Clinical Study Information Center (833-445-3230)
Location: James J. Peters VA Medical Center, Bronx, New York
 

Expanded Access Remdesivir (RDV; GS-5734)

The treatment of communicable Novel Coronavirus of 2019 with Remdesivir (RDV; GS-5734) also known as severe acute respiratory syndrome coronavirus 2.

ID: NCT04302766
Sponsor: US Army Medical Research and Development Command
Contact: Sandi Parriott (sandi.k.parriott.mil@mail.mil)
 

A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

ID: NCT04320615
Sponsor: Hoffmann-La Roche
Location: James J Peters VA Medical Center, Bronx, New York
 

Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation (AVoCaDO)

Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in COVID-19 subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

ID: NCT04357782
Sponsor: Hunter Holmes Mcguire VA Medical CenterContact: Brian Davis (brian.davis5@va.gov)
Location: Hunter Holmes Mcguire VA Medical Center, Richmond, Virginia

Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

This is an expanded access open-label, single-arm, multi-site protocol to provide convalescent plasma as a treatment for patients diagnosed with severe, or life-threatening COVID-19.

ID: NCT04360486
Sponsor: US Army Medical Research and Development Command
Contact: Andrew Cap (andrew.p.cap.mil@mail.mil)
 

VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL) (VA-REACH)

We propose a 3-arm randomized control trial to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among veterans in the outpatient setting.

ID: NCT04363203
Sponsor: Salomeh Keyhani
Location: San Francisco VA Health Care System, California
 

A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia (COVASTIL)

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) or UTTR1147A in combination with standard of care (SOC) compared with matching placebo in combination with SOC in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.

ID: NCT04386616
Sponsor: Genentech
Contact: Study ID Number: GA42469 (global-roche-genentech-trials@gene.com)
Location: Southeast Louisiana Veterans Health Care System, New Orleans

Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH)

The purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of veterans who are hospitalized to an acute care ward due to COVID-19.ID: NCT04397718

Sponsor: VA Office of Research and Development
Contact: Matthew B Rettig (matthew.rettig@va.gov), Nicholas Nickols (nicholas.nickols@va.gov)
Locations: VA Greater Los Angeles Healthcare System, California; VA NY Harbor Healthcare System, New York; VA Puget Sound Health Care System, Seattle, Washington
 

Adaptive COVID-19 Treatment Trial 2 (ACTT-II)

ACTT-II will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29.

ID: NCT04401579
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Contact: Central Contact (dmidclinicaltrials@niaid.nih.gov)
Locations: VA Palo Alto Health Care System, California; Naval Medical Center San Diego, California; Rocky Mountain Regional Veteran Affairs Medical Center, Aurora, Colorado; Southeast Louisiana Veterans Health Care System, New Orleans; Walter Reed National Military Medical Center, Bethesda, Maryland; National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Bethesda, Maryland; Brooke Army Medical Center, Fort Sam Houston, Texas; Madigan Army Medical Center, Tacoma, Washington

High-dose oral famotidine might improve cardinal symptoms of COVID-19 infection, according to the findings of a small outpatient case series and a subsequent retrospective study.

After developing COVID-19 symptoms, the 10 patients in the case series began self-medicating with 60-240 mg famotidine daily over a median of 11 days. “All patients reported marked improvements of disease-related symptoms after starting famotidine,” first author Tobias Janowitz, MD, PhD, of Cold Spring Harbor Laboratory, N.Y., and associates wrote in Gut.

Improvements began within 24-48 hours of starting on the histamine-2 receptor antagonist. By 14 days after treatment initiation, all patients reported near-normalization of both respiratory and systemic symptoms, the researchers reported.

The patients were 23-71 years old. Seven tested positive for COVID-19, two had antibodies to COVID-19, and one had a clinical diagnosis of COVID-19 without laboratory confirmation. Over a median of 11 days (range, 5-21 days), six patients self-administered 80 mg famotidine three times daily and four self-administered lower amounts – from 60 to 150 mg of famotidine daily, divided into two or three doses. Patients started on famotidine between 2 and 26 days after symptom onset.

Through phone interviews and questionnaires, the researchers ascertained changes in cough, dyspnea, fatigue, headache, anosmia, and general unwellness by using a modified four-point Eastern Cooperative Oncology Group (ECOG) performance status scale. Improvements were seen across all symptom categories, and respiratory symptoms improved faster than systemic symptoms. Apart from two cases of persistent anosmia, symptoms resolved completely within 14 days of starting famotidine.

Seven patients reported no side effects of famotidine; one reported grade 1 dizziness and infrequent perceptions of tachycardia; one reported grade 1 dizziness, dry skin, and insomnia; and one reported grade 1 gastrointestinal symptoms and temporary forgetfulness. “Other than forgetfulness, all of these side effects are listed in the prescription information for famotidine, and all side effects resolved on discontinuation of famotidine,” the investigators wrote.

While the findings are intriguing, Dr. Janowitz and associates cautioned against overinterpretation of them. Another expert agreed: “This is a preliminary study based on a hypothesized antiviral effect. It’s important to know that it doesn’t really prove it works,” said Amesh Adalja, MD, senior scholar at the Johns Hopkins University Center for Health Security, Baltimore, and a spokesperson for the Infectious Diseases Society of America, during an interview with MDedge.

These patients might have improved anyway, without self-administering famotidine, said Dr. Adalja, who was not involved in the study.

Furthermore, the mechanism by which famotidine might act on COVID-19 remains unclear. The drug “could have a viral target, for example, one of the viral proteases, or a host target, resulting, for example, in modulation of the immunological response to the virus,” Dr. Janowitz and associates wrote.

Dr. Adalja noted that many compounds show effects against COVID-19 that are not well understood. He called for randomized trials to evaluate the biological plausibility of famotidine use, and its potential efficacy.

“This is a cheap, over-the-counter drug, but no drug is without side effects,” he added. “We need to know whether it works.”

Based on the case series findings, researchers conducted another retrospective study of patients hospitalized with COVID-19 infection. Those who were incidentally taking famotidine before or at hospitalization had a significantly reduced risk of intubation or death, with a hazard ratio of 0.43 (Gastroenterology. 2020 May 22. doi: 10.1053/j.gastro.2020.05.053)

The National Institutes of Health provided partial support. The investigators reported having no conflicts of interest.

SOURCE: Janowitz T et al. Gut. 2020 Jun 4. doi: 10.1136/gutjnl-2020-321852.

High-dose oral famotidine might improve cardinal symptoms of COVID-19 infection, according to the findings of a small outpatient case series and a subsequent retrospective study.

After developing COVID-19 symptoms, the 10 patients in the case series began self-medicating with 60-240 mg famotidine daily over a median of 11 days. “All patients reported marked improvements of disease-related symptoms after starting famotidine,” first author Tobias Janowitz, MD, PhD, of Cold Spring Harbor Laboratory, N.Y., and associates wrote in Gut.

Improvements began within 24-48 hours of starting on the histamine-2 receptor antagonist. By 14 days after treatment initiation, all patients reported near-normalization of both respiratory and systemic symptoms, the researchers reported.

The patients were 23-71 years old. Seven tested positive for COVID-19, two had antibodies to COVID-19, and one had a clinical diagnosis of COVID-19 without laboratory confirmation. Over a median of 11 days (range, 5-21 days), six patients self-administered 80 mg famotidine three times daily and four self-administered lower amounts – from 60 to 150 mg of famotidine daily, divided into two or three doses. Patients started on famotidine between 2 and 26 days after symptom onset.

Through phone interviews and questionnaires, the researchers ascertained changes in cough, dyspnea, fatigue, headache, anosmia, and general unwellness by using a modified four-point Eastern Cooperative Oncology Group (ECOG) performance status scale. Improvements were seen across all symptom categories, and respiratory symptoms improved faster than systemic symptoms. Apart from two cases of persistent anosmia, symptoms resolved completely within 14 days of starting famotidine.

Seven patients reported no side effects of famotidine; one reported grade 1 dizziness and infrequent perceptions of tachycardia; one reported grade 1 dizziness, dry skin, and insomnia; and one reported grade 1 gastrointestinal symptoms and temporary forgetfulness. “Other than forgetfulness, all of these side effects are listed in the prescription information for famotidine, and all side effects resolved on discontinuation of famotidine,” the investigators wrote.

While the findings are intriguing, Dr. Janowitz and associates cautioned against overinterpretation of them. Another expert agreed: “This is a preliminary study based on a hypothesized antiviral effect. It’s important to know that it doesn’t really prove it works,” said Amesh Adalja, MD, senior scholar at the Johns Hopkins University Center for Health Security, Baltimore, and a spokesperson for the Infectious Diseases Society of America, during an interview with MDedge.

These patients might have improved anyway, without self-administering famotidine, said Dr. Adalja, who was not involved in the study.

Furthermore, the mechanism by which famotidine might act on COVID-19 remains unclear. The drug “could have a viral target, for example, one of the viral proteases, or a host target, resulting, for example, in modulation of the immunological response to the virus,” Dr. Janowitz and associates wrote.

Dr. Adalja noted that many compounds show effects against COVID-19 that are not well understood. He called for randomized trials to evaluate the biological plausibility of famotidine use, and its potential efficacy.

“This is a cheap, over-the-counter drug, but no drug is without side effects,” he added. “We need to know whether it works.”

Based on the case series findings, researchers conducted another retrospective study of patients hospitalized with COVID-19 infection. Those who were incidentally taking famotidine before or at hospitalization had a significantly reduced risk of intubation or death, with a hazard ratio of 0.43 (Gastroenterology. 2020 May 22. doi: 10.1053/j.gastro.2020.05.053)

The National Institutes of Health provided partial support. The investigators reported having no conflicts of interest.

SOURCE: Janowitz T et al. Gut. 2020 Jun 4. doi: 10.1136/gutjnl-2020-321852.

High-dose oral famotidine might improve cardinal symptoms of COVID-19 infection, according to the findings of a small outpatient case series and a subsequent retrospective study.

After developing COVID-19 symptoms, the 10 patients in the case series began self-medicating with 60-240 mg famotidine daily over a median of 11 days. “All patients reported marked improvements of disease-related symptoms after starting famotidine,” first author Tobias Janowitz, MD, PhD, of Cold Spring Harbor Laboratory, N.Y., and associates wrote in Gut.

Improvements began within 24-48 hours of starting on the histamine-2 receptor antagonist. By 14 days after treatment initiation, all patients reported near-normalization of both respiratory and systemic symptoms, the researchers reported.

The patients were 23-71 years old. Seven tested positive for COVID-19, two had antibodies to COVID-19, and one had a clinical diagnosis of COVID-19 without laboratory confirmation. Over a median of 11 days (range, 5-21 days), six patients self-administered 80 mg famotidine three times daily and four self-administered lower amounts – from 60 to 150 mg of famotidine daily, divided into two or three doses. Patients started on famotidine between 2 and 26 days after symptom onset.

Through phone interviews and questionnaires, the researchers ascertained changes in cough, dyspnea, fatigue, headache, anosmia, and general unwellness by using a modified four-point Eastern Cooperative Oncology Group (ECOG) performance status scale. Improvements were seen across all symptom categories, and respiratory symptoms improved faster than systemic symptoms. Apart from two cases of persistent anosmia, symptoms resolved completely within 14 days of starting famotidine.

Seven patients reported no side effects of famotidine; one reported grade 1 dizziness and infrequent perceptions of tachycardia; one reported grade 1 dizziness, dry skin, and insomnia; and one reported grade 1 gastrointestinal symptoms and temporary forgetfulness. “Other than forgetfulness, all of these side effects are listed in the prescription information for famotidine, and all side effects resolved on discontinuation of famotidine,” the investigators wrote.

While the findings are intriguing, Dr. Janowitz and associates cautioned against overinterpretation of them. Another expert agreed: “This is a preliminary study based on a hypothesized antiviral effect. It’s important to know that it doesn’t really prove it works,” said Amesh Adalja, MD, senior scholar at the Johns Hopkins University Center for Health Security, Baltimore, and a spokesperson for the Infectious Diseases Society of America, during an interview with MDedge.

These patients might have improved anyway, without self-administering famotidine, said Dr. Adalja, who was not involved in the study.

Furthermore, the mechanism by which famotidine might act on COVID-19 remains unclear. The drug “could have a viral target, for example, one of the viral proteases, or a host target, resulting, for example, in modulation of the immunological response to the virus,” Dr. Janowitz and associates wrote.

Dr. Adalja noted that many compounds show effects against COVID-19 that are not well understood. He called for randomized trials to evaluate the biological plausibility of famotidine use, and its potential efficacy.

“This is a cheap, over-the-counter drug, but no drug is without side effects,” he added. “We need to know whether it works.”

Based on the case series findings, researchers conducted another retrospective study of patients hospitalized with COVID-19 infection. Those who were incidentally taking famotidine before or at hospitalization had a significantly reduced risk of intubation or death, with a hazard ratio of 0.43 (Gastroenterology. 2020 May 22. doi: 10.1053/j.gastro.2020.05.053)

The National Institutes of Health provided partial support. The investigators reported having no conflicts of interest.

SOURCE: Janowitz T et al. Gut. 2020 Jun 4. doi: 10.1136/gutjnl-2020-321852.

Deciding which cancer patients need immediate treatment and who can safely wait is an uncomfortable assessment for cancer clinicians during the COVID-19 pandemic.

In early April, as the COVID-19 surge was bearing down on New York City, those treatment decisions were “a juggling act every single day,” Jonathan Yang, MD, PhD, a radiation oncologist from New York’s Memorial Sloan Kettering Cancer Center, told Medscape Medical News.

Eventually, a glut of guidelines, recommendations, and expert opinions aimed at helping oncologists emerged. The tools help navigate the complicated risk-benefit analysis of their patient’s risk of infection by SARS-CoV-2 and delaying therapy.

Now, a new tool, which appears to be the first of its kind, quantifies that risk-benefit analysis. But its presence immediately raises the question: can it help?
 

Three-Tier Systems Are Not Very Sophisticated

OncCOVID, a free tool that was launched May 26 by the University of Michigan, allows physicians to individualize risk estimates for delaying treatment of up to 25 early- to late-stage cancers. It includes more than 45 patient characteristics, such as age, location, cancer type, cancer stage, treatment plan, underlying medical conditions, and proposed length of delay in care.

Combining these personal details with data from the National Cancer Institute’s SEER (Surveillance, Epidemiology, and End Results) registry and the National Cancer Database, the Michigan app then estimates a patient’s 5- or 10-year survival with immediate vs delayed treatment and weighs that against their risk for COVID-19 using data from the Johns Hopkins Coronavirus Resource Center.

“We thought, isn’t it better to at least provide some evidence-based quantification, rather than a back-of-the-envelope three-tier system that is just sort of ‘made up’?“ explained one of the developers, Daniel Spratt, MD, associate professor of radiation oncology at Michigan Medicine.

Spratt explained that almost every organization, professional society, and government has created something like a three-tier system. Tier 1 represents urgent cases and patients who need immediate treatment. For tier 2, treatment can be delayed weeks or a month, and with tier 3, it can be delayed until the pandemic is over or it’s deemed safe.

“[This system] sounds good at first glance, but in cancer, we’re always talking about personalized medicine, and it’s mind-blowing that these tier systems are only based on urgency and prognosis,” he told Medscape Medical News.

Spratt offered an example. Consider a patient with a very aggressive brain tumor ― that patient is in tier 1 and should undergo treatment immediately. But will the treatment actually help? And how helpful would the procedure be if, say, the patient is 80 years old and, if infected, would have a 30% to 50% chance of dying from the coronavirus?

“If the model says this guy has a 5% harm and this one has 30% harm, you can use that to help prioritize,” summarized Spratt.

The app can generate risk estimates for patients living anywhere in the world and has already been accessed by people from 37 countries. However, Spratt cautions that it is primarily “designed and calibrated for the US.

“The estimates are based on very large US registries, and though it’s probably somewhat similar across much of the world, there’s probably certain cancer types that are more region specific ― especially something like stomach cancer or certain types of head and neck cancer in parts of Asia, for example,” he said.

Although the app’s COVID-19 data are specific to the county level in the United States, elsewhere in the world, it is only country specific.

“We’re using the best data we have for coronavirus, but everyone knows we still have large data gaps,” he acknowledged.
 

How Accurate?

Asked to comment on the app, Richard Bleicher, MD, leader of the Breast Cancer Program at Fox Chase Cancer Center, Philadelphia, praised the effort and the goal but had some concerns.

“Several questions arise, most important of which is, How accurate is this, and how has this been validated, if at all ― especially as it is too soon to see the outcomes of patients affected in this pandemic?” he told Medscape Medical News.

“We are imposing delays on a broad scale because of the coronavirus, and we are getting continuously changing data as we test more patients. But both situations are novel and may not be accurately represented by the data being pulled, because the datasets use patients from a few years ago, and confounders in these datasets may not apply to this situation,” Bleicher continued.

Although acknowledging the “value in delineating the risk of dying from cancer vs the risk of dying from the SARS-CoV-2 pandemic,” Bleicher urged caution in using the tool to make individual patient decisions.

“We need to remember that the best of modeling ... can be wildly inaccurate and needs to be validated using patients having the circumstances in question. ... This won’t be possible until long after the pandemic is completed, and so the model’s accuracy remains unknown.”

That sentiment was echoed by Giampaolo Bianchini, MD, head of the Breast Cancer Group, Department of Medical Oncology, Ospedale San Raffaele, in Milan, Italy.

“Arbitrarily postponing and modifying treatment strategies including surgery, radiation therapy, and medical therapy without properly balancing the risk/benefit ratio may lead to significantly worse cancer-related outcomes, which largely exceed the actual risks for COVID,” he wrote in an email.

“The OncCOVID app is a remarkable attempt to fill the gap between perception and estimation,” he said. The app provides side by side the COVID-19 risk estimation and the consequences of arbitrary deviation from the standard of care, observed Bianchini.

However, he pointed out weaknesses, including the fact that the “data generated in literature are not always of high quality and do not take into consideration relevant characteristics of the disease and treatment benefit. It should for sure be used, but then also interpreted with caution.”

Another Italian group responded more positively.

“In our opinion, it could be a useful tool for clinicians,” wrote colleagues Alessio Cortelinni and Giampiero Porzio, both medical oncologists at San Salvatore Hospital and the University of L’Aquila, in Italy. “This Web app might assist clinicians in balancing the risk/benefit ratio of being treated and/or access to the outpatient cancer center for each kind of patient (both early and advanced stages), in order to make a more tailored counseling,” they wrote in an email. “Importantly, the Web app might help those clinicians who work ‘alone,’ in peripheral centers, without resources, colleagues, and multidisciplinary tumor boards on whom they can rely.”

Bleicher, who was involved in the COVID-19 Breast Cancer Consortium’s recommendations for prioritizing breast cancer treatment, summarized that the app “may end up being close or accurate, but we won’t know except in hindsight.”
 

This article first appeared on Medscape.com.

Deciding which cancer patients need immediate treatment and who can safely wait is an uncomfortable assessment for cancer clinicians during the COVID-19 pandemic.

In early April, as the COVID-19 surge was bearing down on New York City, those treatment decisions were “a juggling act every single day,” Jonathan Yang, MD, PhD, a radiation oncologist from New York’s Memorial Sloan Kettering Cancer Center, told Medscape Medical News.

Eventually, a glut of guidelines, recommendations, and expert opinions aimed at helping oncologists emerged. The tools help navigate the complicated risk-benefit analysis of their patient’s risk of infection by SARS-CoV-2 and delaying therapy.

Now, a new tool, which appears to be the first of its kind, quantifies that risk-benefit analysis. But its presence immediately raises the question: can it help?
 

Three-Tier Systems Are Not Very Sophisticated

OncCOVID, a free tool that was launched May 26 by the University of Michigan, allows physicians to individualize risk estimates for delaying treatment of up to 25 early- to late-stage cancers. It includes more than 45 patient characteristics, such as age, location, cancer type, cancer stage, treatment plan, underlying medical conditions, and proposed length of delay in care.

Combining these personal details with data from the National Cancer Institute’s SEER (Surveillance, Epidemiology, and End Results) registry and the National Cancer Database, the Michigan app then estimates a patient’s 5- or 10-year survival with immediate vs delayed treatment and weighs that against their risk for COVID-19 using data from the Johns Hopkins Coronavirus Resource Center.

“We thought, isn’t it better to at least provide some evidence-based quantification, rather than a back-of-the-envelope three-tier system that is just sort of ‘made up’?“ explained one of the developers, Daniel Spratt, MD, associate professor of radiation oncology at Michigan Medicine.

Spratt explained that almost every organization, professional society, and government has created something like a three-tier system. Tier 1 represents urgent cases and patients who need immediate treatment. For tier 2, treatment can be delayed weeks or a month, and with tier 3, it can be delayed until the pandemic is over or it’s deemed safe.

“[This system] sounds good at first glance, but in cancer, we’re always talking about personalized medicine, and it’s mind-blowing that these tier systems are only based on urgency and prognosis,” he told Medscape Medical News.

Spratt offered an example. Consider a patient with a very aggressive brain tumor ― that patient is in tier 1 and should undergo treatment immediately. But will the treatment actually help? And how helpful would the procedure be if, say, the patient is 80 years old and, if infected, would have a 30% to 50% chance of dying from the coronavirus?

“If the model says this guy has a 5% harm and this one has 30% harm, you can use that to help prioritize,” summarized Spratt.

The app can generate risk estimates for patients living anywhere in the world and has already been accessed by people from 37 countries. However, Spratt cautions that it is primarily “designed and calibrated for the US.

“The estimates are based on very large US registries, and though it’s probably somewhat similar across much of the world, there’s probably certain cancer types that are more region specific ― especially something like stomach cancer or certain types of head and neck cancer in parts of Asia, for example,” he said.

Although the app’s COVID-19 data are specific to the county level in the United States, elsewhere in the world, it is only country specific.

“We’re using the best data we have for coronavirus, but everyone knows we still have large data gaps,” he acknowledged.
 

How Accurate?

Asked to comment on the app, Richard Bleicher, MD, leader of the Breast Cancer Program at Fox Chase Cancer Center, Philadelphia, praised the effort and the goal but had some concerns.

“Several questions arise, most important of which is, How accurate is this, and how has this been validated, if at all ― especially as it is too soon to see the outcomes of patients affected in this pandemic?” he told Medscape Medical News.

“We are imposing delays on a broad scale because of the coronavirus, and we are getting continuously changing data as we test more patients. But both situations are novel and may not be accurately represented by the data being pulled, because the datasets use patients from a few years ago, and confounders in these datasets may not apply to this situation,” Bleicher continued.

Although acknowledging the “value in delineating the risk of dying from cancer vs the risk of dying from the SARS-CoV-2 pandemic,” Bleicher urged caution in using the tool to make individual patient decisions.

“We need to remember that the best of modeling ... can be wildly inaccurate and needs to be validated using patients having the circumstances in question. ... This won’t be possible until long after the pandemic is completed, and so the model’s accuracy remains unknown.”

That sentiment was echoed by Giampaolo Bianchini, MD, head of the Breast Cancer Group, Department of Medical Oncology, Ospedale San Raffaele, in Milan, Italy.

“Arbitrarily postponing and modifying treatment strategies including surgery, radiation therapy, and medical therapy without properly balancing the risk/benefit ratio may lead to significantly worse cancer-related outcomes, which largely exceed the actual risks for COVID,” he wrote in an email.

“The OncCOVID app is a remarkable attempt to fill the gap between perception and estimation,” he said. The app provides side by side the COVID-19 risk estimation and the consequences of arbitrary deviation from the standard of care, observed Bianchini.

However, he pointed out weaknesses, including the fact that the “data generated in literature are not always of high quality and do not take into consideration relevant characteristics of the disease and treatment benefit. It should for sure be used, but then also interpreted with caution.”

Another Italian group responded more positively.

“In our opinion, it could be a useful tool for clinicians,” wrote colleagues Alessio Cortelinni and Giampiero Porzio, both medical oncologists at San Salvatore Hospital and the University of L’Aquila, in Italy. “This Web app might assist clinicians in balancing the risk/benefit ratio of being treated and/or access to the outpatient cancer center for each kind of patient (both early and advanced stages), in order to make a more tailored counseling,” they wrote in an email. “Importantly, the Web app might help those clinicians who work ‘alone,’ in peripheral centers, without resources, colleagues, and multidisciplinary tumor boards on whom they can rely.”

Bleicher, who was involved in the COVID-19 Breast Cancer Consortium’s recommendations for prioritizing breast cancer treatment, summarized that the app “may end up being close or accurate, but we won’t know except in hindsight.”
 

This article first appeared on Medscape.com.

Deciding which cancer patients need immediate treatment and who can safely wait is an uncomfortable assessment for cancer clinicians during the COVID-19 pandemic.

In early April, as the COVID-19 surge was bearing down on New York City, those treatment decisions were “a juggling act every single day,” Jonathan Yang, MD, PhD, a radiation oncologist from New York’s Memorial Sloan Kettering Cancer Center, told Medscape Medical News.

Eventually, a glut of guidelines, recommendations, and expert opinions aimed at helping oncologists emerged. The tools help navigate the complicated risk-benefit analysis of their patient’s risk of infection by SARS-CoV-2 and delaying therapy.

Now, a new tool, which appears to be the first of its kind, quantifies that risk-benefit analysis. But its presence immediately raises the question: can it help?
 

Three-Tier Systems Are Not Very Sophisticated

OncCOVID, a free tool that was launched May 26 by the University of Michigan, allows physicians to individualize risk estimates for delaying treatment of up to 25 early- to late-stage cancers. It includes more than 45 patient characteristics, such as age, location, cancer type, cancer stage, treatment plan, underlying medical conditions, and proposed length of delay in care.

Combining these personal details with data from the National Cancer Institute’s SEER (Surveillance, Epidemiology, and End Results) registry and the National Cancer Database, the Michigan app then estimates a patient’s 5- or 10-year survival with immediate vs delayed treatment and weighs that against their risk for COVID-19 using data from the Johns Hopkins Coronavirus Resource Center.

“We thought, isn’t it better to at least provide some evidence-based quantification, rather than a back-of-the-envelope three-tier system that is just sort of ‘made up’?“ explained one of the developers, Daniel Spratt, MD, associate professor of radiation oncology at Michigan Medicine.

Spratt explained that almost every organization, professional society, and government has created something like a three-tier system. Tier 1 represents urgent cases and patients who need immediate treatment. For tier 2, treatment can be delayed weeks or a month, and with tier 3, it can be delayed until the pandemic is over or it’s deemed safe.

“[This system] sounds good at first glance, but in cancer, we’re always talking about personalized medicine, and it’s mind-blowing that these tier systems are only based on urgency and prognosis,” he told Medscape Medical News.

Spratt offered an example. Consider a patient with a very aggressive brain tumor ― that patient is in tier 1 and should undergo treatment immediately. But will the treatment actually help? And how helpful would the procedure be if, say, the patient is 80 years old and, if infected, would have a 30% to 50% chance of dying from the coronavirus?

“If the model says this guy has a 5% harm and this one has 30% harm, you can use that to help prioritize,” summarized Spratt.

The app can generate risk estimates for patients living anywhere in the world and has already been accessed by people from 37 countries. However, Spratt cautions that it is primarily “designed and calibrated for the US.

“The estimates are based on very large US registries, and though it’s probably somewhat similar across much of the world, there’s probably certain cancer types that are more region specific ― especially something like stomach cancer or certain types of head and neck cancer in parts of Asia, for example,” he said.

Although the app’s COVID-19 data are specific to the county level in the United States, elsewhere in the world, it is only country specific.

“We’re using the best data we have for coronavirus, but everyone knows we still have large data gaps,” he acknowledged.
 

How Accurate?

Asked to comment on the app, Richard Bleicher, MD, leader of the Breast Cancer Program at Fox Chase Cancer Center, Philadelphia, praised the effort and the goal but had some concerns.

“Several questions arise, most important of which is, How accurate is this, and how has this been validated, if at all ― especially as it is too soon to see the outcomes of patients affected in this pandemic?” he told Medscape Medical News.

“We are imposing delays on a broad scale because of the coronavirus, and we are getting continuously changing data as we test more patients. But both situations are novel and may not be accurately represented by the data being pulled, because the datasets use patients from a few years ago, and confounders in these datasets may not apply to this situation,” Bleicher continued.

Although acknowledging the “value in delineating the risk of dying from cancer vs the risk of dying from the SARS-CoV-2 pandemic,” Bleicher urged caution in using the tool to make individual patient decisions.

“We need to remember that the best of modeling ... can be wildly inaccurate and needs to be validated using patients having the circumstances in question. ... This won’t be possible until long after the pandemic is completed, and so the model’s accuracy remains unknown.”

That sentiment was echoed by Giampaolo Bianchini, MD, head of the Breast Cancer Group, Department of Medical Oncology, Ospedale San Raffaele, in Milan, Italy.

“Arbitrarily postponing and modifying treatment strategies including surgery, radiation therapy, and medical therapy without properly balancing the risk/benefit ratio may lead to significantly worse cancer-related outcomes, which largely exceed the actual risks for COVID,” he wrote in an email.

“The OncCOVID app is a remarkable attempt to fill the gap between perception and estimation,” he said. The app provides side by side the COVID-19 risk estimation and the consequences of arbitrary deviation from the standard of care, observed Bianchini.

However, he pointed out weaknesses, including the fact that the “data generated in literature are not always of high quality and do not take into consideration relevant characteristics of the disease and treatment benefit. It should for sure be used, but then also interpreted with caution.”

Another Italian group responded more positively.

“In our opinion, it could be a useful tool for clinicians,” wrote colleagues Alessio Cortelinni and Giampiero Porzio, both medical oncologists at San Salvatore Hospital and the University of L’Aquila, in Italy. “This Web app might assist clinicians in balancing the risk/benefit ratio of being treated and/or access to the outpatient cancer center for each kind of patient (both early and advanced stages), in order to make a more tailored counseling,” they wrote in an email. “Importantly, the Web app might help those clinicians who work ‘alone,’ in peripheral centers, without resources, colleagues, and multidisciplinary tumor boards on whom they can rely.”

Bleicher, who was involved in the COVID-19 Breast Cancer Consortium’s recommendations for prioritizing breast cancer treatment, summarized that the app “may end up being close or accurate, but we won’t know except in hindsight.”
 

This article first appeared on Medscape.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Answers to your top telehealth coding questions

How long can we continue using telehealth? How do I select a level of office visit? How do I bill for behavioral health services if I am not able to conduct in-person visits?

Our coding expert has fielded these and other questions from physicians ever since the Centers for Medicare & Medicaid Services expanded use of telehealth during the COVID-19 emergency. Find the answers to these questions and get more expert tips on how to code properly to miximize reimbursement.

Read more.

Asymptomatic COVID-19 spread

A WHO official has stated that it appears to be “rare” that an asymptomatic individual can pass SARS-CoV-2 to someone else.

“From the data we have, it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual,” Maria Van Kerkhove, PhD, WHO’s COVID-19 technical lead and an infectious disease epidemiologist, said June 8 at a news briefing from the agency’s Geneva headquarters.

This announcement came on the heels of the publication of an analysis in the Annals of Internal Medicine, which suggested that as many as 40-45% of COVID-19 cases may be asymptomatic. In this paper, the authors, Daniel P. Oran, AM, and Eric J. Topol, MD, of the Scripps Research Translational Institute in La Jolla, Calif stated: “The likelihood that approximately 40%-45% of those infected with SARS-CoV-2 will remain asymptomatic suggests that the virus might have greater potential than previously estimated to spread silently and deeply through human populations.” Read more.

Biologics and melanoma risk

New data suggest patients taking biologics for inflammatory bowel disease, rheumatoid arthritis, or psoriasis may have an increased risk of melanoma, but the association was not statistically significant in a systematic review and meta-analysis.

The study, published in JAMA Dermatology, assessed melanoma risk in 34,029 patients receiving biologics and 135,370 patients receiving conventional systemic therapy for IBD, RA, or psoriasis, using data from seven cohort studies.

The researchers analyzed the pooled relative risk across all studies. Compared with patients who received conventional systemic therapy, there was a nonsignificant association with risk of melanoma in patients with psoriasis (hazard ratio, 1.57), RA (pooled relative risk, 1.20), and IBD (pRR, 1.20).

Previous studies that have found an increased risk of melanoma in patients on biologics for these three conditions have “typically used the general population as the comparator,” the investigators noted. There is a large amount of evidence that has established short-term efficacy and safety of biologics, compared with conventional systemic treatments, but concerns about longer-term cancer risk associated with biologics remains a concern. “We advocate for more large, well-designed studies of this issue to be performed to help improve certainty,” the researchers said.

Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Answers to your top telehealth coding questions

How long can we continue using telehealth? How do I select a level of office visit? How do I bill for behavioral health services if I am not able to conduct in-person visits?

Our coding expert has fielded these and other questions from physicians ever since the Centers for Medicare & Medicaid Services expanded use of telehealth during the COVID-19 emergency. Find the answers to these questions and get more expert tips on how to code properly to miximize reimbursement.

Read more.

Asymptomatic COVID-19 spread

A WHO official has stated that it appears to be “rare” that an asymptomatic individual can pass SARS-CoV-2 to someone else.

“From the data we have, it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual,” Maria Van Kerkhove, PhD, WHO’s COVID-19 technical lead and an infectious disease epidemiologist, said June 8 at a news briefing from the agency’s Geneva headquarters.

This announcement came on the heels of the publication of an analysis in the Annals of Internal Medicine, which suggested that as many as 40-45% of COVID-19 cases may be asymptomatic. In this paper, the authors, Daniel P. Oran, AM, and Eric J. Topol, MD, of the Scripps Research Translational Institute in La Jolla, Calif stated: “The likelihood that approximately 40%-45% of those infected with SARS-CoV-2 will remain asymptomatic suggests that the virus might have greater potential than previously estimated to spread silently and deeply through human populations.” Read more.

Biologics and melanoma risk

New data suggest patients taking biologics for inflammatory bowel disease, rheumatoid arthritis, or psoriasis may have an increased risk of melanoma, but the association was not statistically significant in a systematic review and meta-analysis.

The study, published in JAMA Dermatology, assessed melanoma risk in 34,029 patients receiving biologics and 135,370 patients receiving conventional systemic therapy for IBD, RA, or psoriasis, using data from seven cohort studies.

The researchers analyzed the pooled relative risk across all studies. Compared with patients who received conventional systemic therapy, there was a nonsignificant association with risk of melanoma in patients with psoriasis (hazard ratio, 1.57), RA (pooled relative risk, 1.20), and IBD (pRR, 1.20).

Previous studies that have found an increased risk of melanoma in patients on biologics for these three conditions have “typically used the general population as the comparator,” the investigators noted. There is a large amount of evidence that has established short-term efficacy and safety of biologics, compared with conventional systemic treatments, but concerns about longer-term cancer risk associated with biologics remains a concern. “We advocate for more large, well-designed studies of this issue to be performed to help improve certainty,” the researchers said.

Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Answers to your top telehealth coding questions

How long can we continue using telehealth? How do I select a level of office visit? How do I bill for behavioral health services if I am not able to conduct in-person visits?

Our coding expert has fielded these and other questions from physicians ever since the Centers for Medicare & Medicaid Services expanded use of telehealth during the COVID-19 emergency. Find the answers to these questions and get more expert tips on how to code properly to miximize reimbursement.

Read more.

Asymptomatic COVID-19 spread

A WHO official has stated that it appears to be “rare” that an asymptomatic individual can pass SARS-CoV-2 to someone else.

“From the data we have, it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual,” Maria Van Kerkhove, PhD, WHO’s COVID-19 technical lead and an infectious disease epidemiologist, said June 8 at a news briefing from the agency’s Geneva headquarters.

This announcement came on the heels of the publication of an analysis in the Annals of Internal Medicine, which suggested that as many as 40-45% of COVID-19 cases may be asymptomatic. In this paper, the authors, Daniel P. Oran, AM, and Eric J. Topol, MD, of the Scripps Research Translational Institute in La Jolla, Calif stated: “The likelihood that approximately 40%-45% of those infected with SARS-CoV-2 will remain asymptomatic suggests that the virus might have greater potential than previously estimated to spread silently and deeply through human populations.” Read more.

Biologics and melanoma risk

New data suggest patients taking biologics for inflammatory bowel disease, rheumatoid arthritis, or psoriasis may have an increased risk of melanoma, but the association was not statistically significant in a systematic review and meta-analysis.

The study, published in JAMA Dermatology, assessed melanoma risk in 34,029 patients receiving biologics and 135,370 patients receiving conventional systemic therapy for IBD, RA, or psoriasis, using data from seven cohort studies.

The researchers analyzed the pooled relative risk across all studies. Compared with patients who received conventional systemic therapy, there was a nonsignificant association with risk of melanoma in patients with psoriasis (hazard ratio, 1.57), RA (pooled relative risk, 1.20), and IBD (pRR, 1.20).

Previous studies that have found an increased risk of melanoma in patients on biologics for these three conditions have “typically used the general population as the comparator,” the investigators noted. There is a large amount of evidence that has established short-term efficacy and safety of biologics, compared with conventional systemic treatments, but concerns about longer-term cancer risk associated with biologics remains a concern. “We advocate for more large, well-designed studies of this issue to be performed to help improve certainty,” the researchers said.

Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

An official with the World Health Organization (WHO) has stated that it appears to be “rare” that an asymptomatic individual can pass SARS-CoV-2 to someone else.

“From the data we have, it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual,” Maria Van Kerkhove, PhD, WHO’s COVID-19 technical lead and an infectious disease epidemiologist, said June 8 at a news briefing from the agency’s Geneva headquarters.

This announcement came on the heels of the publication of an analysis in the Annals of Internal Medicine, which suggested that as many as 40-45% of COVID-19 cases may be asymptomatic. In this paper, the authors, Daniel P. Oran, AM, and Eric J. Topol, MD, of the Scripps Research Translational Institute in La Jolla, Calif stated: “The likelihood that approximately 40%-45% of those infected with SARS-CoV-2 will remain asymptomatic suggests that the virus might have greater potential than previously estimated to spread silently and deeply through human populations.”

"The early data that we have assembled on the prevalence of asymptomatic SARS-CoV-2 infection suggest that this is a significant factor in the rapid progression of the COVID-19 pandemic," the authors concluded.

Dr. Van Kerkhove also made comments suggesting otherwise on Twitter, citing a new summary by WHO: “@WHO recently published a summary of transmission of #COVID19, incl. symptomatic, pre-symptomatic and asymptomatic transmission.”

She also tweeted the following lines from the WHO summary: “Comprehensive studies on transmission from asymptomatic individuals are difficult to conduct, but the available evidence from contact tracing reported by Member States suggests that asymptomatically-infected individuals are much less likely to transmit the virus than those who develop symptoms.” 

In an additional post, Dr. Van Kerkhove added: “In these data, it is important to breakdown truly asymptomatic vs pre-symptomatic vs mildly symptomatic... also to note that the [percentage] reported or estimated to be ‘asymptomatic’ is not the same as the [percentage] that are asymptomatic that actually transmit.”

In the paper published in the Annals of Internal Medicine, Mr. Oran and Dr. Topol analyzed data of asymptomatic individuals from 16 cohorts between April 19 and May 26, 2020 – a wide-ranging group consisting of residents of cities, health care workers, individuals in homeless shelters, obstetric patients, residents of a nursing home, crew members of aircraft carriers, passengers on cruise ships, and inmates in correctional facilities. Each cohort had varying rates of asymptomatic or presymptomatic cases..

When residents of Iceland were tested, 43 of 100 individuals who tested positive for SARS-CoV-2 did not show symptoms. In Vo’, Italy, 30 of 73 people (41.1%) with positive SARS-CoV-2 test results did not have symptoms in a first round of testing, and 13 of 29 (44.8%) had no symptoms in a second round of testing. Over half of residents of San Francisco’s Mission District who received testing (39 of 74; 52.7%) did not have symptoms, while slightly less than half of Indiana residents tested showed no symptoms (35 of 78; 44.8%).

A majority of 41 individuals (65.9%) who were mostly health care workers at Rutgers University reported no symptoms of COVID-19 at the time of testing. Data from homeless shelters in Boston (129 of 147; 87.7%) and Los Angeles (27 of 43; 62.7%) also showed a high rate of individuals without symptoms. Among 33 obstetric patients in New York City who tested positive for SARS-CoV-2, 29 women (87.9%) were asymptomatic during a median 2-day length of stay. In a Washington state nursing facility, 12 of 23 individuals (52.1%) were positive for SARS-CoV-2 without showing symptoms in a first round of testing, with another 15 of 24 residents (62.5%) not showing symptoms in a second round of testing. Of these residents, 24 individuals (88.9%) later went on to show symptoms of COVID-19.

SOURCE: Oran DP, Topol EJ. Ann Intern Med. 2020 Jun 3. doi: 10.7326/M20-3012.

This article was updated 6/8/20.

An official with the World Health Organization (WHO) has stated that it appears to be “rare” that an asymptomatic individual can pass SARS-CoV-2 to someone else.

“From the data we have, it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual,” Maria Van Kerkhove, PhD, WHO’s COVID-19 technical lead and an infectious disease epidemiologist, said June 8 at a news briefing from the agency’s Geneva headquarters.

This announcement came on the heels of the publication of an analysis in the Annals of Internal Medicine, which suggested that as many as 40-45% of COVID-19 cases may be asymptomatic. In this paper, the authors, Daniel P. Oran, AM, and Eric J. Topol, MD, of the Scripps Research Translational Institute in La Jolla, Calif stated: “The likelihood that approximately 40%-45% of those infected with SARS-CoV-2 will remain asymptomatic suggests that the virus might have greater potential than previously estimated to spread silently and deeply through human populations.”

"The early data that we have assembled on the prevalence of asymptomatic SARS-CoV-2 infection suggest that this is a significant factor in the rapid progression of the COVID-19 pandemic," the authors concluded.

Dr. Van Kerkhove also made comments suggesting otherwise on Twitter, citing a new summary by WHO: “@WHO recently published a summary of transmission of #COVID19, incl. symptomatic, pre-symptomatic and asymptomatic transmission.”

She also tweeted the following lines from the WHO summary: “Comprehensive studies on transmission from asymptomatic individuals are difficult to conduct, but the available evidence from contact tracing reported by Member States suggests that asymptomatically-infected individuals are much less likely to transmit the virus than those who develop symptoms.” 

In an additional post, Dr. Van Kerkhove added: “In these data, it is important to breakdown truly asymptomatic vs pre-symptomatic vs mildly symptomatic... also to note that the [percentage] reported or estimated to be ‘asymptomatic’ is not the same as the [percentage] that are asymptomatic that actually transmit.”

In the paper published in the Annals of Internal Medicine, Mr. Oran and Dr. Topol analyzed data of asymptomatic individuals from 16 cohorts between April 19 and May 26, 2020 – a wide-ranging group consisting of residents of cities, health care workers, individuals in homeless shelters, obstetric patients, residents of a nursing home, crew members of aircraft carriers, passengers on cruise ships, and inmates in correctional facilities. Each cohort had varying rates of asymptomatic or presymptomatic cases..

When residents of Iceland were tested, 43 of 100 individuals who tested positive for SARS-CoV-2 did not show symptoms. In Vo’, Italy, 30 of 73 people (41.1%) with positive SARS-CoV-2 test results did not have symptoms in a first round of testing, and 13 of 29 (44.8%) had no symptoms in a second round of testing. Over half of residents of San Francisco’s Mission District who received testing (39 of 74; 52.7%) did not have symptoms, while slightly less than half of Indiana residents tested showed no symptoms (35 of 78; 44.8%).

A majority of 41 individuals (65.9%) who were mostly health care workers at Rutgers University reported no symptoms of COVID-19 at the time of testing. Data from homeless shelters in Boston (129 of 147; 87.7%) and Los Angeles (27 of 43; 62.7%) also showed a high rate of individuals without symptoms. Among 33 obstetric patients in New York City who tested positive for SARS-CoV-2, 29 women (87.9%) were asymptomatic during a median 2-day length of stay. In a Washington state nursing facility, 12 of 23 individuals (52.1%) were positive for SARS-CoV-2 without showing symptoms in a first round of testing, with another 15 of 24 residents (62.5%) not showing symptoms in a second round of testing. Of these residents, 24 individuals (88.9%) later went on to show symptoms of COVID-19.

SOURCE: Oran DP, Topol EJ. Ann Intern Med. 2020 Jun 3. doi: 10.7326/M20-3012.

This article was updated 6/8/20.

An official with the World Health Organization (WHO) has stated that it appears to be “rare” that an asymptomatic individual can pass SARS-CoV-2 to someone else.

“From the data we have, it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual,” Maria Van Kerkhove, PhD, WHO’s COVID-19 technical lead and an infectious disease epidemiologist, said June 8 at a news briefing from the agency’s Geneva headquarters.

This announcement came on the heels of the publication of an analysis in the Annals of Internal Medicine, which suggested that as many as 40-45% of COVID-19 cases may be asymptomatic. In this paper, the authors, Daniel P. Oran, AM, and Eric J. Topol, MD, of the Scripps Research Translational Institute in La Jolla, Calif stated: “The likelihood that approximately 40%-45% of those infected with SARS-CoV-2 will remain asymptomatic suggests that the virus might have greater potential than previously estimated to spread silently and deeply through human populations.”

"The early data that we have assembled on the prevalence of asymptomatic SARS-CoV-2 infection suggest that this is a significant factor in the rapid progression of the COVID-19 pandemic," the authors concluded.

Dr. Van Kerkhove also made comments suggesting otherwise on Twitter, citing a new summary by WHO: “@WHO recently published a summary of transmission of #COVID19, incl. symptomatic, pre-symptomatic and asymptomatic transmission.”

She also tweeted the following lines from the WHO summary: “Comprehensive studies on transmission from asymptomatic individuals are difficult to conduct, but the available evidence from contact tracing reported by Member States suggests that asymptomatically-infected individuals are much less likely to transmit the virus than those who develop symptoms.” 

In an additional post, Dr. Van Kerkhove added: “In these data, it is important to breakdown truly asymptomatic vs pre-symptomatic vs mildly symptomatic... also to note that the [percentage] reported or estimated to be ‘asymptomatic’ is not the same as the [percentage] that are asymptomatic that actually transmit.”

In the paper published in the Annals of Internal Medicine, Mr. Oran and Dr. Topol analyzed data of asymptomatic individuals from 16 cohorts between April 19 and May 26, 2020 – a wide-ranging group consisting of residents of cities, health care workers, individuals in homeless shelters, obstetric patients, residents of a nursing home, crew members of aircraft carriers, passengers on cruise ships, and inmates in correctional facilities. Each cohort had varying rates of asymptomatic or presymptomatic cases..

When residents of Iceland were tested, 43 of 100 individuals who tested positive for SARS-CoV-2 did not show symptoms. In Vo’, Italy, 30 of 73 people (41.1%) with positive SARS-CoV-2 test results did not have symptoms in a first round of testing, and 13 of 29 (44.8%) had no symptoms in a second round of testing. Over half of residents of San Francisco’s Mission District who received testing (39 of 74; 52.7%) did not have symptoms, while slightly less than half of Indiana residents tested showed no symptoms (35 of 78; 44.8%).

A majority of 41 individuals (65.9%) who were mostly health care workers at Rutgers University reported no symptoms of COVID-19 at the time of testing. Data from homeless shelters in Boston (129 of 147; 87.7%) and Los Angeles (27 of 43; 62.7%) also showed a high rate of individuals without symptoms. Among 33 obstetric patients in New York City who tested positive for SARS-CoV-2, 29 women (87.9%) were asymptomatic during a median 2-day length of stay. In a Washington state nursing facility, 12 of 23 individuals (52.1%) were positive for SARS-CoV-2 without showing symptoms in a first round of testing, with another 15 of 24 residents (62.5%) not showing symptoms in a second round of testing. Of these residents, 24 individuals (88.9%) later went on to show symptoms of COVID-19.

SOURCE: Oran DP, Topol EJ. Ann Intern Med. 2020 Jun 3. doi: 10.7326/M20-3012.

This article was updated 6/8/20.

Recent concerns surrounding coronavirus disease 2019 (COVID-19) make it timely to reexamine the complex findings related to eating disorders and the immune system, and the risks for and detection of infection in patients with anorexia nervosa (AN) and similar disorders. To date, there are no published studies evaluating patients with eating disorders and COVID-19. However, it may be helpful to review the data on the infectious process in this patient population to improve patient communication, enhance surveillance and detection, and possibly reduce morbidity and mortality.

The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) issued warnings that individuals who are older, have underlying medical conditions, and/or are immunocompromised face the greatest risk of serious complications and death as a result of COVID-19, the disease process caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to malnutrition, patients with eating disorders, especially AN, may be perceived to have an increased risk of medical conditions and infection. Despite many studies on specific changes and differences in the immune system of patients with eating disorders, the consequences of these changes remain controversial and inconclusive.

This article reviews research on eating disorders, focusing on published data regarding the effects of AN on the immune system, susceptibility to infections, infectious detection, and morbidity. We also discuss clinical considerations related to COVID-19 and patients with AN.

Infection risks: Conflicting data

In a 1981 study that included 9 participants, Golla et al¹ concluded that patients with AN may have “resistance” to infections based on a suggested protective factor within the immune system of these patients. Because this study has been cited repeatedly in multiple articles about AN and cell-mediated immunity,^2-7 some clinicians have accepted this evidence of resistance to infection in patients with AN, which may lower their suspicion for and detection of infections in patients with AN.

However, studies published both before and after Golla et al¹ have shown statistically significant results that contradict those researchers’ conclusion. A study that compared the medical records of 68 patients with AN with those who did not have AN found no significant difference, and concluded that the rate of infection among patients with AN is the same as among controls.⁸ These researchers noted that infection rates may be higher among patients with later-stage, more severe AN. In a 1986 study of 12 patients with AN, Cason et al⁹ concluded that while cellular immunity function is abnormal in patients with AN, their results were not compatible with prior studies that suggested AN patients were more resistant to infection.^1,2,8

More recently, researchers compared 1,592 patients with eating disorders with 6,368 matched controls; they reviewed prescriptions of antibacterial, antifungal, and antiviral medications as a measure of infection rates.¹⁰ Compared with controls, patients with binge eating disorder (BED), patients with bulimia nervosa (BN), and males with AN more often received prescriptions for antimicrobial medications. There was no statistically significant difference between controls and females with AN, which is consistent with other reports of no increased or decreased risk of infection among females with AN. In terms of antiviral use, this study showed an increased prescription of antivirals only in the BN group.

Several other studies examining the rate of infection in patients with AN concluded that there is neither an increased nor decreased rate of infection in patients with AN, and that the rate of infection in this population is similar to that of the general population.^8,10-12 Because studies that have included patients with AN have evaluated only symptomatic viral infections, some researchers have proposed that patients with AN may show lower rates of symptomatic viral infection but higher rates of asymptomatic infection, as evidenced by higher viral titers.⁶ Further research is required. Despite controversy regarding infection rates, studies have found that patients with AN have increased rates of morbidity and mortality from infections.^6,12-16

Continue to: Obstacles to detecting infections

Obstacles to detecting infections

Several factors can complicate the surveillance and detection of infections in patients with eating disorders, especially those with AN. These include:

• an accepted predisposition to infection secondary to malnutrition
• a lack of visual or reported infectious symptoms
• misrepresentation and assumptions from published research.

Clinicians who report fewer observed cases of infections among patients with AN may be overlooking comorbid disease processes due to a bias from the literature and/or a lack of awareness of symptom parameters in patients with AN.

Features of AN include a loss of adipose tissue responsible for pro-inflammatory cytokines, and excessive exercise, which stimulates anti-inflammatory myokines. This can modulate the experience of illness that impacts the core features of disease,¹⁷ possibly reducing symptomatic presentation of infections.

Fever. The presence and intensity of fever may be altered in patients with eating disorders, especially those with AN. In a study of 311 inpatients with AN, researchers found that patients with AN had a significant delay in fever response in AN.¹² Of 23 patients with an active bacterial infection, all but 5 had a fever <37°C, with some as low as 35.5°C. A detectable fever response and unexplained fevers were found in 2 of the 6 patients with a viral infection. A series of case studies found that patients with AN with bacterial infections also had a delayed fever response.¹⁸

For patients with infections that commonly present with fever, such as COVID-19, a delayed fever response can delay or evade the detection of infection, thus increasing potential complications as well viral exposure to others. Thus, clinicians should use caution when ruling out COVID-19 or other infections because of a lack of significant fever.

Continue to: Overlapping symptoms

Overlapping symptoms. The symptoms of viral infection can mimic the symptoms of AN, which further complicates screening and diagnosis of infection in these patients. Although up to 80% of individuals infected with COVID-19 may be asymptomatic or have a mild presentation, the most common reported symptoms are fever (92.6%), shortness of breath (50.8%), expectoration (41.4%), fatigue (46.4%), dry cough (33.3%), and myalgia (21.4%).^19-21 Gastrointestinal (GI) symptoms have been reported in patients with COVID-19, as well as a loss of taste and smell.

Commonly reported physical symptoms of AN include an intolerance to cold, general fatigue, muscle aches and pains, restlessness, emesis, and a multitude of GI complaints. Patients with AN also have been reported to experience shortness of breath due to conditions such as respiratory muscle weakness,²² nutritional emphysema,²³ and anxiety and panic attack.²⁴ These conditions could lead to an increased susceptibility to COVID-19 and increased complications during treatment. Cardiac abnormalities, which are common in patients with AN and BN, may increase the risk of adverse events. While these symptoms may be an important part of screening for diseases such as COVID-19, suspicion of infection also may be lower because of the overlap of AN symptomology, underlying conditions, and a delayed fever response.

Laboratory findings. Laboratory testing results for patients with COVID-19 include lower lymphocyte counts, higher leukocyte counts, elevated levels of infection-related biomarkers and inflammatory cytokines, and significantly decreased T-cell counts.¹⁹ Similar values are also found in patients with AN.

The similar clinical presentations and laboratory values of AN and COVID-19 could lead to delayed diagnosis, increased disease transmission, cross-contamination of facilities, and higher incidences of medical complications and mortality.

The immunology of AN and correlations with COVID-19

Many studies examining the immune system of patients with eating disorders, especially those with AN, have discovered changes and differences in both cell-mediated and humoral response to infections.^{1,3,5,7,9,11,16,21,25-27} Whether these differences represent a dysfunctional immune system, an immunocompromised state, or even a protective factor remains unclear.

Continue to: While some studies have reported...

While some studies have reported that AN represents an immunocompromised state, others describe the immune system of patients with AN as dysfunctional or simply altered.^9,11,22,28 Some studies have found that patients with AN had delayed reactions to pathogen skin exposures compared with healthy controls, which provides evidence of an impaired cell-mediated immune system.^9,27,29

Some studies have considered the consequences of infection and immunologic findings as markers of or contributing to the onset of AN.^2,30,31 Numerous studies have noted abnormalities in AN with regards to cell-mediated immunity, the humoral system, the lymphoreticular system, and the innate immune system, and potential contributions from increased oxidative stress, a chronically activated sympathetic nervous system and hypothalamic-pituitary-adrenal axis, altered intestinal microbiota, and an abnormal bone marrow microenvironment.²

Box 1

Box 1^19,25,32-34 describes some of the initial immunologic findings reported in patients with COVID-19. In Box 2,^{5,8,11,13,14,19,26,28,35-40} we discuss reports that describe the immunologic overlay of COVID-19 and AN.

Box 2

Malnutrition and the immune system

Differences in the type of malnutrition observed in low-weight patients with AN may help explain why patients with AN can maintain a relatively intact cell-mediated immune system.¹ Protein-energy malnutrition (PEM), which is found in typical states of starvation, consists of deficiencies in multiple vitamins, protein, and energy (caloric content), whereas the dietary habits of patients with AN usually result in a deficiency of carbohydrates and fats.⁴¹ Studies that examined the impact of PEM on immunity to influenza infection have suggested that balanced protein energy replenishment may be a strategy for boosting immunity against influenza viral infections.⁴² However, carbohydrates are the primary nutrients for human bone marrow fat cells, which play a crucial role in the maturation of white blood cells. This may account for the leukopenia that is common in patients with AN.^6,43 The protein-sparing aspect of the typical AN diet may account for the immune system changes observed in patients with AN.⁴⁴

Although some studies have proposed that immune deficiencies observed in patients with AN are secondary to malnutrition and return to normal with refeeding,^5,40,45 others have concluded that immune function is not compromised by factors such as nutritional status or body weight in AN.^26,43,46

Continue to: Clinical considerations

 

 

Clinical considerations

Neither the CDC nor the WHO have issued a specific protocol for monitoring for and treating COVID-19 in patients with eating disorders; however, the guidelines offered by these organizations for the general population should be followed for patients with eating disorders.

When screening a patient with an eating disorder, keep in mind that the symptoms of eating disorders, such as AN, may mimic an infectious process. Mood symptoms, such as depression or anxiety, could represent physiological responses to infection. Patients with GI symptoms that typically are considered part of the pathology of an eating disorder should be more carefully considered for COVID-19. Monitor a patient’s basal body temperature, and be mindful that a patient with AN may exhibit a delayed fever response. Be vigilant for a recent loss of taste or smell, which should raise suspicion for COVID-19. When monitoring vital signs, pay careful attention for any decompensation in a patient’s pulse oximetry. Whenever possible, order COVID-19 testing for any patient you suspect may be infected.

Outpatient clinicians should work closely in a collaborative manner with a patient’s eating disorder treatment team. Psychiatrists, primary care physicians, psychotherapists, nutritionists, and other clinicians should all follow CDC/WHO guidelines regarding COVID-19, provide surveillance, and communicate any suspicions to the medical team. Eating disorder treatment programs, including residential centers, partial hospital programs (PHP), and intensive outpatient programs (IOP), must enhance monitoring for COVID-19, and exercise caution by practicing social distancing and providing adequate personal protective equipment for patients and staff. To reduce the spread of COVID-19, many IOPs and PHPs have transitioned to virtual treatment. Residential centers must carefully screen patients before admission to weigh the risks and benefits of inpatient vs outpatient care.

Bottom Line

Differences in the immune system of patients with an eating disorder do not necessarily confer a higher or lower risk of infection. Symptoms of some infections can mimic the symptoms of anorexia nervosa. Recognizing infections in patients with eating disorders is critical because compared with the general population, they have higher rates of infection-related morbidity and mortality.

Related Resources

• Congress J, Madaan V. 6 ‘M’s to keep in mind when you next see a patient with anorexia nervosa. Current Psychiatry. 2014;13(5):58-59.
• Westmoreland P. Eating disorders: Masterclass lecture part I. Psychcast (podcast). https://www.mdedge.com/podcasts/psychcast/eating-disorders-masterclass-lecture-part-i.

Recent concerns surrounding coronavirus disease 2019 (COVID-19) make it timely to reexamine the complex findings related to eating disorders and the immune system, and the risks for and detection of infection in patients with anorexia nervosa (AN) and similar disorders. To date, there are no published studies evaluating patients with eating disorders and COVID-19. However, it may be helpful to review the data on the infectious process in this patient population to improve patient communication, enhance surveillance and detection, and possibly reduce morbidity and mortality.

The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) issued warnings that individuals who are older, have underlying medical conditions, and/or are immunocompromised face the greatest risk of serious complications and death as a result of COVID-19, the disease process caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to malnutrition, patients with eating disorders, especially AN, may be perceived to have an increased risk of medical conditions and infection. Despite many studies on specific changes and differences in the immune system of patients with eating disorders, the consequences of these changes remain controversial and inconclusive.

This article reviews research on eating disorders, focusing on published data regarding the effects of AN on the immune system, susceptibility to infections, infectious detection, and morbidity. We also discuss clinical considerations related to COVID-19 and patients with AN.

Infection risks: Conflicting data

In a 1981 study that included 9 participants, Golla et al¹ concluded that patients with AN may have “resistance” to infections based on a suggested protective factor within the immune system of these patients. Because this study has been cited repeatedly in multiple articles about AN and cell-mediated immunity,^2-7 some clinicians have accepted this evidence of resistance to infection in patients with AN, which may lower their suspicion for and detection of infections in patients with AN.

However, studies published both before and after Golla et al¹ have shown statistically significant results that contradict those researchers’ conclusion. A study that compared the medical records of 68 patients with AN with those who did not have AN found no significant difference, and concluded that the rate of infection among patients with AN is the same as among controls.⁸ These researchers noted that infection rates may be higher among patients with later-stage, more severe AN. In a 1986 study of 12 patients with AN, Cason et al⁹ concluded that while cellular immunity function is abnormal in patients with AN, their results were not compatible with prior studies that suggested AN patients were more resistant to infection.^1,2,8

More recently, researchers compared 1,592 patients with eating disorders with 6,368 matched controls; they reviewed prescriptions of antibacterial, antifungal, and antiviral medications as a measure of infection rates.¹⁰ Compared with controls, patients with binge eating disorder (BED), patients with bulimia nervosa (BN), and males with AN more often received prescriptions for antimicrobial medications. There was no statistically significant difference between controls and females with AN, which is consistent with other reports of no increased or decreased risk of infection among females with AN. In terms of antiviral use, this study showed an increased prescription of antivirals only in the BN group.

Several other studies examining the rate of infection in patients with AN concluded that there is neither an increased nor decreased rate of infection in patients with AN, and that the rate of infection in this population is similar to that of the general population.^8,10-12 Because studies that have included patients with AN have evaluated only symptomatic viral infections, some researchers have proposed that patients with AN may show lower rates of symptomatic viral infection but higher rates of asymptomatic infection, as evidenced by higher viral titers.⁶ Further research is required. Despite controversy regarding infection rates, studies have found that patients with AN have increased rates of morbidity and mortality from infections.^6,12-16

Continue to: Obstacles to detecting infections

Obstacles to detecting infections

Several factors can complicate the surveillance and detection of infections in patients with eating disorders, especially those with AN. These include:

• an accepted predisposition to infection secondary to malnutrition
• a lack of visual or reported infectious symptoms
• misrepresentation and assumptions from published research.

Clinicians who report fewer observed cases of infections among patients with AN may be overlooking comorbid disease processes due to a bias from the literature and/or a lack of awareness of symptom parameters in patients with AN.

Features of AN include a loss of adipose tissue responsible for pro-inflammatory cytokines, and excessive exercise, which stimulates anti-inflammatory myokines. This can modulate the experience of illness that impacts the core features of disease,¹⁷ possibly reducing symptomatic presentation of infections.

Fever. The presence and intensity of fever may be altered in patients with eating disorders, especially those with AN. In a study of 311 inpatients with AN, researchers found that patients with AN had a significant delay in fever response in AN.¹² Of 23 patients with an active bacterial infection, all but 5 had a fever <37°C, with some as low as 35.5°C. A detectable fever response and unexplained fevers were found in 2 of the 6 patients with a viral infection. A series of case studies found that patients with AN with bacterial infections also had a delayed fever response.¹⁸

For patients with infections that commonly present with fever, such as COVID-19, a delayed fever response can delay or evade the detection of infection, thus increasing potential complications as well viral exposure to others. Thus, clinicians should use caution when ruling out COVID-19 or other infections because of a lack of significant fever.

Continue to: Overlapping symptoms

Overlapping symptoms. The symptoms of viral infection can mimic the symptoms of AN, which further complicates screening and diagnosis of infection in these patients. Although up to 80% of individuals infected with COVID-19 may be asymptomatic or have a mild presentation, the most common reported symptoms are fever (92.6%), shortness of breath (50.8%), expectoration (41.4%), fatigue (46.4%), dry cough (33.3%), and myalgia (21.4%).^19-21 Gastrointestinal (GI) symptoms have been reported in patients with COVID-19, as well as a loss of taste and smell.

Commonly reported physical symptoms of AN include an intolerance to cold, general fatigue, muscle aches and pains, restlessness, emesis, and a multitude of GI complaints. Patients with AN also have been reported to experience shortness of breath due to conditions such as respiratory muscle weakness,²² nutritional emphysema,²³ and anxiety and panic attack.²⁴ These conditions could lead to an increased susceptibility to COVID-19 and increased complications during treatment. Cardiac abnormalities, which are common in patients with AN and BN, may increase the risk of adverse events. While these symptoms may be an important part of screening for diseases such as COVID-19, suspicion of infection also may be lower because of the overlap of AN symptomology, underlying conditions, and a delayed fever response.

Laboratory findings. Laboratory testing results for patients with COVID-19 include lower lymphocyte counts, higher leukocyte counts, elevated levels of infection-related biomarkers and inflammatory cytokines, and significantly decreased T-cell counts.¹⁹ Similar values are also found in patients with AN.

The similar clinical presentations and laboratory values of AN and COVID-19 could lead to delayed diagnosis, increased disease transmission, cross-contamination of facilities, and higher incidences of medical complications and mortality.

The immunology of AN and correlations with COVID-19

Many studies examining the immune system of patients with eating disorders, especially those with AN, have discovered changes and differences in both cell-mediated and humoral response to infections.^{1,3,5,7,9,11,16,21,25-27} Whether these differences represent a dysfunctional immune system, an immunocompromised state, or even a protective factor remains unclear.

Continue to: While some studies have reported...

While some studies have reported that AN represents an immunocompromised state, others describe the immune system of patients with AN as dysfunctional or simply altered.^9,11,22,28 Some studies have found that patients with AN had delayed reactions to pathogen skin exposures compared with healthy controls, which provides evidence of an impaired cell-mediated immune system.^9,27,29

Some studies have considered the consequences of infection and immunologic findings as markers of or contributing to the onset of AN.^2,30,31 Numerous studies have noted abnormalities in AN with regards to cell-mediated immunity, the humoral system, the lymphoreticular system, and the innate immune system, and potential contributions from increased oxidative stress, a chronically activated sympathetic nervous system and hypothalamic-pituitary-adrenal axis, altered intestinal microbiota, and an abnormal bone marrow microenvironment.²

Box 1

Box 1^19,25,32-34 describes some of the initial immunologic findings reported in patients with COVID-19. In Box 2,^{5,8,11,13,14,19,26,28,35-40} we discuss reports that describe the immunologic overlay of COVID-19 and AN.

Box 2

Malnutrition and the immune system

Differences in the type of malnutrition observed in low-weight patients with AN may help explain why patients with AN can maintain a relatively intact cell-mediated immune system.¹ Protein-energy malnutrition (PEM), which is found in typical states of starvation, consists of deficiencies in multiple vitamins, protein, and energy (caloric content), whereas the dietary habits of patients with AN usually result in a deficiency of carbohydrates and fats.⁴¹ Studies that examined the impact of PEM on immunity to influenza infection have suggested that balanced protein energy replenishment may be a strategy for boosting immunity against influenza viral infections.⁴² However, carbohydrates are the primary nutrients for human bone marrow fat cells, which play a crucial role in the maturation of white blood cells. This may account for the leukopenia that is common in patients with AN.^6,43 The protein-sparing aspect of the typical AN diet may account for the immune system changes observed in patients with AN.⁴⁴

Although some studies have proposed that immune deficiencies observed in patients with AN are secondary to malnutrition and return to normal with refeeding,^5,40,45 others have concluded that immune function is not compromised by factors such as nutritional status or body weight in AN.^26,43,46

Continue to: Clinical considerations

 

 

Clinical considerations

Neither the CDC nor the WHO have issued a specific protocol for monitoring for and treating COVID-19 in patients with eating disorders; however, the guidelines offered by these organizations for the general population should be followed for patients with eating disorders.

When screening a patient with an eating disorder, keep in mind that the symptoms of eating disorders, such as AN, may mimic an infectious process. Mood symptoms, such as depression or anxiety, could represent physiological responses to infection. Patients with GI symptoms that typically are considered part of the pathology of an eating disorder should be more carefully considered for COVID-19. Monitor a patient’s basal body temperature, and be mindful that a patient with AN may exhibit a delayed fever response. Be vigilant for a recent loss of taste or smell, which should raise suspicion for COVID-19. When monitoring vital signs, pay careful attention for any decompensation in a patient’s pulse oximetry. Whenever possible, order COVID-19 testing for any patient you suspect may be infected.

Outpatient clinicians should work closely in a collaborative manner with a patient’s eating disorder treatment team. Psychiatrists, primary care physicians, psychotherapists, nutritionists, and other clinicians should all follow CDC/WHO guidelines regarding COVID-19, provide surveillance, and communicate any suspicions to the medical team. Eating disorder treatment programs, including residential centers, partial hospital programs (PHP), and intensive outpatient programs (IOP), must enhance monitoring for COVID-19, and exercise caution by practicing social distancing and providing adequate personal protective equipment for patients and staff. To reduce the spread of COVID-19, many IOPs and PHPs have transitioned to virtual treatment. Residential centers must carefully screen patients before admission to weigh the risks and benefits of inpatient vs outpatient care.

Bottom Line

Differences in the immune system of patients with an eating disorder do not necessarily confer a higher or lower risk of infection. Symptoms of some infections can mimic the symptoms of anorexia nervosa. Recognizing infections in patients with eating disorders is critical because compared with the general population, they have higher rates of infection-related morbidity and mortality.

Related Resources

• Congress J, Madaan V. 6 ‘M’s to keep in mind when you next see a patient with anorexia nervosa. Current Psychiatry. 2014;13(5):58-59.
• Westmoreland P. Eating disorders: Masterclass lecture part I. Psychcast (podcast). https://www.mdedge.com/podcasts/psychcast/eating-disorders-masterclass-lecture-part-i.

Recent concerns surrounding coronavirus disease 2019 (COVID-19) make it timely to reexamine the complex findings related to eating disorders and the immune system, and the risks for and detection of infection in patients with anorexia nervosa (AN) and similar disorders. To date, there are no published studies evaluating patients with eating disorders and COVID-19. However, it may be helpful to review the data on the infectious process in this patient population to improve patient communication, enhance surveillance and detection, and possibly reduce morbidity and mortality.

The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) issued warnings that individuals who are older, have underlying medical conditions, and/or are immunocompromised face the greatest risk of serious complications and death as a result of COVID-19, the disease process caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to malnutrition, patients with eating disorders, especially AN, may be perceived to have an increased risk of medical conditions and infection. Despite many studies on specific changes and differences in the immune system of patients with eating disorders, the consequences of these changes remain controversial and inconclusive.

This article reviews research on eating disorders, focusing on published data regarding the effects of AN on the immune system, susceptibility to infections, infectious detection, and morbidity. We also discuss clinical considerations related to COVID-19 and patients with AN.

Infection risks: Conflicting data

In a 1981 study that included 9 participants, Golla et al¹ concluded that patients with AN may have “resistance” to infections based on a suggested protective factor within the immune system of these patients. Because this study has been cited repeatedly in multiple articles about AN and cell-mediated immunity,^2-7 some clinicians have accepted this evidence of resistance to infection in patients with AN, which may lower their suspicion for and detection of infections in patients with AN.

However, studies published both before and after Golla et al¹ have shown statistically significant results that contradict those researchers’ conclusion. A study that compared the medical records of 68 patients with AN with those who did not have AN found no significant difference, and concluded that the rate of infection among patients with AN is the same as among controls.⁸ These researchers noted that infection rates may be higher among patients with later-stage, more severe AN. In a 1986 study of 12 patients with AN, Cason et al⁹ concluded that while cellular immunity function is abnormal in patients with AN, their results were not compatible with prior studies that suggested AN patients were more resistant to infection.^1,2,8

More recently, researchers compared 1,592 patients with eating disorders with 6,368 matched controls; they reviewed prescriptions of antibacterial, antifungal, and antiviral medications as a measure of infection rates.¹⁰ Compared with controls, patients with binge eating disorder (BED), patients with bulimia nervosa (BN), and males with AN more often received prescriptions for antimicrobial medications. There was no statistically significant difference between controls and females with AN, which is consistent with other reports of no increased or decreased risk of infection among females with AN. In terms of antiviral use, this study showed an increased prescription of antivirals only in the BN group.

Several other studies examining the rate of infection in patients with AN concluded that there is neither an increased nor decreased rate of infection in patients with AN, and that the rate of infection in this population is similar to that of the general population.^8,10-12 Because studies that have included patients with AN have evaluated only symptomatic viral infections, some researchers have proposed that patients with AN may show lower rates of symptomatic viral infection but higher rates of asymptomatic infection, as evidenced by higher viral titers.⁶ Further research is required. Despite controversy regarding infection rates, studies have found that patients with AN have increased rates of morbidity and mortality from infections.^6,12-16

Continue to: Obstacles to detecting infections

Obstacles to detecting infections

Several factors can complicate the surveillance and detection of infections in patients with eating disorders, especially those with AN. These include:

• an accepted predisposition to infection secondary to malnutrition
• a lack of visual or reported infectious symptoms
• misrepresentation and assumptions from published research.

Clinicians who report fewer observed cases of infections among patients with AN may be overlooking comorbid disease processes due to a bias from the literature and/or a lack of awareness of symptom parameters in patients with AN.

Features of AN include a loss of adipose tissue responsible for pro-inflammatory cytokines, and excessive exercise, which stimulates anti-inflammatory myokines. This can modulate the experience of illness that impacts the core features of disease,¹⁷ possibly reducing symptomatic presentation of infections.

Fever. The presence and intensity of fever may be altered in patients with eating disorders, especially those with AN. In a study of 311 inpatients with AN, researchers found that patients with AN had a significant delay in fever response in AN.¹² Of 23 patients with an active bacterial infection, all but 5 had a fever <37°C, with some as low as 35.5°C. A detectable fever response and unexplained fevers were found in 2 of the 6 patients with a viral infection. A series of case studies found that patients with AN with bacterial infections also had a delayed fever response.¹⁸

For patients with infections that commonly present with fever, such as COVID-19, a delayed fever response can delay or evade the detection of infection, thus increasing potential complications as well viral exposure to others. Thus, clinicians should use caution when ruling out COVID-19 or other infections because of a lack of significant fever.

Continue to: Overlapping symptoms

Overlapping symptoms. The symptoms of viral infection can mimic the symptoms of AN, which further complicates screening and diagnosis of infection in these patients. Although up to 80% of individuals infected with COVID-19 may be asymptomatic or have a mild presentation, the most common reported symptoms are fever (92.6%), shortness of breath (50.8%), expectoration (41.4%), fatigue (46.4%), dry cough (33.3%), and myalgia (21.4%).^19-21 Gastrointestinal (GI) symptoms have been reported in patients with COVID-19, as well as a loss of taste and smell.

Commonly reported physical symptoms of AN include an intolerance to cold, general fatigue, muscle aches and pains, restlessness, emesis, and a multitude of GI complaints. Patients with AN also have been reported to experience shortness of breath due to conditions such as respiratory muscle weakness,²² nutritional emphysema,²³ and anxiety and panic attack.²⁴ These conditions could lead to an increased susceptibility to COVID-19 and increased complications during treatment. Cardiac abnormalities, which are common in patients with AN and BN, may increase the risk of adverse events. While these symptoms may be an important part of screening for diseases such as COVID-19, suspicion of infection also may be lower because of the overlap of AN symptomology, underlying conditions, and a delayed fever response.

Laboratory findings. Laboratory testing results for patients with COVID-19 include lower lymphocyte counts, higher leukocyte counts, elevated levels of infection-related biomarkers and inflammatory cytokines, and significantly decreased T-cell counts.¹⁹ Similar values are also found in patients with AN.

The similar clinical presentations and laboratory values of AN and COVID-19 could lead to delayed diagnosis, increased disease transmission, cross-contamination of facilities, and higher incidences of medical complications and mortality.

The immunology of AN and correlations with COVID-19

Many studies examining the immune system of patients with eating disorders, especially those with AN, have discovered changes and differences in both cell-mediated and humoral response to infections.^{1,3,5,7,9,11,16,21,25-27} Whether these differences represent a dysfunctional immune system, an immunocompromised state, or even a protective factor remains unclear.

Continue to: While some studies have reported...

While some studies have reported that AN represents an immunocompromised state, others describe the immune system of patients with AN as dysfunctional or simply altered.^9,11,22,28 Some studies have found that patients with AN had delayed reactions to pathogen skin exposures compared with healthy controls, which provides evidence of an impaired cell-mediated immune system.^9,27,29

Some studies have considered the consequences of infection and immunologic findings as markers of or contributing to the onset of AN.^2,30,31 Numerous studies have noted abnormalities in AN with regards to cell-mediated immunity, the humoral system, the lymphoreticular system, and the innate immune system, and potential contributions from increased oxidative stress, a chronically activated sympathetic nervous system and hypothalamic-pituitary-adrenal axis, altered intestinal microbiota, and an abnormal bone marrow microenvironment.²

Box 1

Box 1^19,25,32-34 describes some of the initial immunologic findings reported in patients with COVID-19. In Box 2,^{5,8,11,13,14,19,26,28,35-40} we discuss reports that describe the immunologic overlay of COVID-19 and AN.

Box 2

Malnutrition and the immune system

Differences in the type of malnutrition observed in low-weight patients with AN may help explain why patients with AN can maintain a relatively intact cell-mediated immune system.¹ Protein-energy malnutrition (PEM), which is found in typical states of starvation, consists of deficiencies in multiple vitamins, protein, and energy (caloric content), whereas the dietary habits of patients with AN usually result in a deficiency of carbohydrates and fats.⁴¹ Studies that examined the impact of PEM on immunity to influenza infection have suggested that balanced protein energy replenishment may be a strategy for boosting immunity against influenza viral infections.⁴² However, carbohydrates are the primary nutrients for human bone marrow fat cells, which play a crucial role in the maturation of white blood cells. This may account for the leukopenia that is common in patients with AN.^6,43 The protein-sparing aspect of the typical AN diet may account for the immune system changes observed in patients with AN.⁴⁴

Although some studies have proposed that immune deficiencies observed in patients with AN are secondary to malnutrition and return to normal with refeeding,^5,40,45 others have concluded that immune function is not compromised by factors such as nutritional status or body weight in AN.^26,43,46

Continue to: Clinical considerations

 

 

Clinical considerations

Neither the CDC nor the WHO have issued a specific protocol for monitoring for and treating COVID-19 in patients with eating disorders; however, the guidelines offered by these organizations for the general population should be followed for patients with eating disorders.

When screening a patient with an eating disorder, keep in mind that the symptoms of eating disorders, such as AN, may mimic an infectious process. Mood symptoms, such as depression or anxiety, could represent physiological responses to infection. Patients with GI symptoms that typically are considered part of the pathology of an eating disorder should be more carefully considered for COVID-19. Monitor a patient’s basal body temperature, and be mindful that a patient with AN may exhibit a delayed fever response. Be vigilant for a recent loss of taste or smell, which should raise suspicion for COVID-19. When monitoring vital signs, pay careful attention for any decompensation in a patient’s pulse oximetry. Whenever possible, order COVID-19 testing for any patient you suspect may be infected.

Outpatient clinicians should work closely in a collaborative manner with a patient’s eating disorder treatment team. Psychiatrists, primary care physicians, psychotherapists, nutritionists, and other clinicians should all follow CDC/WHO guidelines regarding COVID-19, provide surveillance, and communicate any suspicions to the medical team. Eating disorder treatment programs, including residential centers, partial hospital programs (PHP), and intensive outpatient programs (IOP), must enhance monitoring for COVID-19, and exercise caution by practicing social distancing and providing adequate personal protective equipment for patients and staff. To reduce the spread of COVID-19, many IOPs and PHPs have transitioned to virtual treatment. Residential centers must carefully screen patients before admission to weigh the risks and benefits of inpatient vs outpatient care.

Bottom Line

Differences in the immune system of patients with an eating disorder do not necessarily confer a higher or lower risk of infection. Symptoms of some infections can mimic the symptoms of anorexia nervosa. Recognizing infections in patients with eating disorders is critical because compared with the general population, they have higher rates of infection-related morbidity and mortality.

Related Resources

• Congress J, Madaan V. 6 ‘M’s to keep in mind when you next see a patient with anorexia nervosa. Current Psychiatry. 2014;13(5):58-59.
• Westmoreland P. Eating disorders: Masterclass lecture part I. Psychcast (podcast). https://www.mdedge.com/podcasts/psychcast/eating-disorders-masterclass-lecture-part-i.

Here are the stories our MDedge editors across specialties think you need to know about today:

#WhiteCoats4BlackLives stands up to racism

Participants in the growing #WhiteCoats4BlackLives protest against racism say it is a chance to use their status as trusted messengers, show themselves as allies of people of color, and demonstrate that they are familiar with how racism has contributed to health disparities.

The medical student-run group WhiteCoats4BlackLives has helped organize ongoing, large-scale events at hospitals, medical campuses, and city centers nationwide.“It’s important to use our platform for good,” said Danielle Verghese, MD, a first-year internal medicine resident at Thomas Jefferson University Hospital in Philadelphia, who helped recruit a small group of students, residents, and pharmacy school students to take part in a kneel-in late last month in a city park.

“As a doctor, most people in society regard me with a certain amount of respect and may listen if I say something,” Dr. Verghese said.

Read more.
 

A conversation on race

In this special episode of the Psychcast podast, host Lorenzo Norris, MD, and fourth-year psychiatry resident Brandon C. Newsome, MD, discuss race relations as physicians in the wake of the death of George Floyd. The pair discuss what their patients are experiencing and what they’re experiencing as black physicians.

“Racism – whether or not you witness it, whether or not you utilize it, whether or not you are the subject of it – affects and hurts us all,” Dr. Norris says. “We all have to start to own that. You can’t just stay siloed, because it is going to affect you.” Listen here.
 

Two journals retract studies on HCQ

The Lancet has retracted a highly cited study that suggested hydroxychloroquine (HCQ) may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.

Three authors of the Lancet article wrote in a letter that the action came after concerns were raised about the integrity of the data, and about how the analysis was conducted by Chicago-based Surgisphere Corp and study coauthor Sapan Desai, MD, Surgisphere’s founder and CEO. The authors asked for an independent third-party review of Surgisphere to evaluate the integrity of the trial elements and to replicate the analyses in the article.

“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, as such transfer would violate client agreements and confidentiality requirements,” the authors wrote, leading them to request a retraction of the paper.

In a similar note, the authors requested that the New England Journal of Medicine retract the earlier article as well.

Both journals had already published “Expression of Concern” notices about the articles. The expression of concern followed an open letter, endorsed by more than 200 scientists, ethicists, and clinicians and posted on May 28, questioning the data and ethics of the study.

Read more.

FDA approves antibiotic to treat pneumonia

The Food and Drug Administration has approved Recarbrio (imipenem-cilastatin and relebactam) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia in people aged 18 years and older.

Approval for Recarbrio was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired and ventilator-associated bacterial pneumonia who received either Recarbrio or piperacillin-tazobactam. After 28 days, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam had died.

“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments. These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible,” said Sumathi Nambiar, MD, MPH, of the agency’s Center for Drug Evaluation and Research.

Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

#WhiteCoats4BlackLives stands up to racism

Participants in the growing #WhiteCoats4BlackLives protest against racism say it is a chance to use their status as trusted messengers, show themselves as allies of people of color, and demonstrate that they are familiar with how racism has contributed to health disparities.

The medical student-run group WhiteCoats4BlackLives has helped organize ongoing, large-scale events at hospitals, medical campuses, and city centers nationwide.“It’s important to use our platform for good,” said Danielle Verghese, MD, a first-year internal medicine resident at Thomas Jefferson University Hospital in Philadelphia, who helped recruit a small group of students, residents, and pharmacy school students to take part in a kneel-in late last month in a city park.

“As a doctor, most people in society regard me with a certain amount of respect and may listen if I say something,” Dr. Verghese said.

Read more.
 

A conversation on race

In this special episode of the Psychcast podast, host Lorenzo Norris, MD, and fourth-year psychiatry resident Brandon C. Newsome, MD, discuss race relations as physicians in the wake of the death of George Floyd. The pair discuss what their patients are experiencing and what they’re experiencing as black physicians.

“Racism – whether or not you witness it, whether or not you utilize it, whether or not you are the subject of it – affects and hurts us all,” Dr. Norris says. “We all have to start to own that. You can’t just stay siloed, because it is going to affect you.” Listen here.
 

Two journals retract studies on HCQ

The Lancet has retracted a highly cited study that suggested hydroxychloroquine (HCQ) may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.

Three authors of the Lancet article wrote in a letter that the action came after concerns were raised about the integrity of the data, and about how the analysis was conducted by Chicago-based Surgisphere Corp and study coauthor Sapan Desai, MD, Surgisphere’s founder and CEO. The authors asked for an independent third-party review of Surgisphere to evaluate the integrity of the trial elements and to replicate the analyses in the article.

“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, as such transfer would violate client agreements and confidentiality requirements,” the authors wrote, leading them to request a retraction of the paper.

In a similar note, the authors requested that the New England Journal of Medicine retract the earlier article as well.

Both journals had already published “Expression of Concern” notices about the articles. The expression of concern followed an open letter, endorsed by more than 200 scientists, ethicists, and clinicians and posted on May 28, questioning the data and ethics of the study.

Read more.

FDA approves antibiotic to treat pneumonia

The Food and Drug Administration has approved Recarbrio (imipenem-cilastatin and relebactam) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia in people aged 18 years and older.

Approval for Recarbrio was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired and ventilator-associated bacterial pneumonia who received either Recarbrio or piperacillin-tazobactam. After 28 days, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam had died.

“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments. These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible,” said Sumathi Nambiar, MD, MPH, of the agency’s Center for Drug Evaluation and Research.

Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

#WhiteCoats4BlackLives stands up to racism

Participants in the growing #WhiteCoats4BlackLives protest against racism say it is a chance to use their status as trusted messengers, show themselves as allies of people of color, and demonstrate that they are familiar with how racism has contributed to health disparities.

The medical student-run group WhiteCoats4BlackLives has helped organize ongoing, large-scale events at hospitals, medical campuses, and city centers nationwide.“It’s important to use our platform for good,” said Danielle Verghese, MD, a first-year internal medicine resident at Thomas Jefferson University Hospital in Philadelphia, who helped recruit a small group of students, residents, and pharmacy school students to take part in a kneel-in late last month in a city park.

“As a doctor, most people in society regard me with a certain amount of respect and may listen if I say something,” Dr. Verghese said.

Read more.
 

A conversation on race

In this special episode of the Psychcast podast, host Lorenzo Norris, MD, and fourth-year psychiatry resident Brandon C. Newsome, MD, discuss race relations as physicians in the wake of the death of George Floyd. The pair discuss what their patients are experiencing and what they’re experiencing as black physicians.

“Racism – whether or not you witness it, whether or not you utilize it, whether or not you are the subject of it – affects and hurts us all,” Dr. Norris says. “We all have to start to own that. You can’t just stay siloed, because it is going to affect you.” Listen here.
 

Two journals retract studies on HCQ

The Lancet has retracted a highly cited study that suggested hydroxychloroquine (HCQ) may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.

Three authors of the Lancet article wrote in a letter that the action came after concerns were raised about the integrity of the data, and about how the analysis was conducted by Chicago-based Surgisphere Corp and study coauthor Sapan Desai, MD, Surgisphere’s founder and CEO. The authors asked for an independent third-party review of Surgisphere to evaluate the integrity of the trial elements and to replicate the analyses in the article.

“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, as such transfer would violate client agreements and confidentiality requirements,” the authors wrote, leading them to request a retraction of the paper.

In a similar note, the authors requested that the New England Journal of Medicine retract the earlier article as well.

Both journals had already published “Expression of Concern” notices about the articles. The expression of concern followed an open letter, endorsed by more than 200 scientists, ethicists, and clinicians and posted on May 28, questioning the data and ethics of the study.

Read more.

FDA approves antibiotic to treat pneumonia

The Food and Drug Administration has approved Recarbrio (imipenem-cilastatin and relebactam) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia in people aged 18 years and older.

Approval for Recarbrio was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired and ventilator-associated bacterial pneumonia who received either Recarbrio or piperacillin-tazobactam. After 28 days, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam had died.

“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments. These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible,” said Sumathi Nambiar, MD, MPH, of the agency’s Center for Drug Evaluation and Research.

Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Lillie Shockney, RN, MAS, a two-time breast cancer survivor and adjunct professor at Johns Hopkins School of Nursing in Baltimore, Maryland, mourns the many losses that her patients with advanced cancer now face in the midst of the COVID-19 pandemic. But in the void of the usual support networks and treatment plans, she sees the resurgence of something that has recently been crowded out: hospice.

The pandemic has forced patients and their physicians to reassess the risk/benefit balance of continuing or embarking on yet another cancer treatment.

“It’s one of the pearls that we will get out of this nightmare,” said Ms. Shockney, who recently retired as administrative director of the cancer survivorship programs at the Sidney Kimmel Comprehensive Cancer Center.

“Physicians have been taught to treat the disease – so as long as there’s a treatment they give another treatment,” she told Medscape Medical News during a Zoom call from her home. “But for some patients with advanced disease, those treatments were making them very sick, so they were trading longevity over quality of life.”

Of course, longevity has never been a guarantee with cancer treatment, and even less so now, with the risk of COVID-19.

“This is going to bring them to some hard discussions,” says Brenda Nevidjon, RN, MSN, chief executive officer at the Oncology Nursing Society.

“We’ve known for a long time that there are patients who are on third- and fourth-round treatment options that have very little evidence of prolonging life or quality of life,” she told Medscape Medical News. “Do we bring these people out of their home to a setting where there could be a fair number of COVID-positive patients? Do we expose them to that?”

Across the world, these dilemmas are pushing cancer specialists to initiate discussions of hospice sooner with patients who have advanced disease, and with more clarity than before.

One of the reasons such conversations have often been avoided is that the concept of hospice is generally misunderstood, said Ms. Shockney.

“Patients think ‘you’re giving up on me, you’ve abandoned me’, but hospice is all about preserving the remainder of their quality of life and letting them have time with family and time to fulfill those elements of experiencing a good and peaceful death,” she said.

Indeed, hospice is “a benefit meant for somebody with at least a 6-month horizon,” agrees Ms. Nevidjon. Yet the average length of hospice in the United States is just 5 days. “It’s at the very, very end, and yet for some of these patients the 6 months they could get in hospice might be a better quality of life than the 4 months on another whole plan of chemotherapy. I can’t imagine that on the backside of this pandemic we will not have learned and we won’t start to change practices around initiating more of these conversations.”
 

Silver lining of this pandemic?

It’s too early into the pandemic to have hard data on whether hospice uptake has increased, but “it’s encouraging to hear that hospice is being discussed and offered sooner as an alternative to that third- or fourth-round chemo,” said Lori Bishop, MHA, RN, vice president of palliative and advanced care at the National Hospice and Palliative Care Organization.

“I agree that improving informed-decision discussions and timely access to hospice is a silver lining of the pandemic,” she told Medscape Medical News.

But she points out that today’s hospice looks quite different than it did before the pandemic, with the immediate and very obvious difference being telehealth, which was not widely utilized previously.

In March, the Centers for Medicare & Medicaid Services expanded telehealth options for hospice providers, something that Ms. Bishop and other hospice providers hope will remain in place after the pandemic passes.

“Telehealth visits are offered to replace some in-home visits both to minimize risk of exposure to COVID-19 and reduce the drain on personal protective equipment,” Bishop explained.

“In-patient hospice programs are also finding unique ways to provide support and connect patients to their loved ones: visitors are allowed but limited to one or two. Music and pet therapy are being provided through the window or virtually and devices such as iPads are being used to help patients connect with loved ones,” she said.

Telehealth links patients out of loneliness, but the one thing it cannot do is provide the comfort of touch – an important part of any hospice program.

“Hand-holding ... I miss that a lot,” says Ms. Shockney, her eyes filling with tears. “When you take somebody’s hand, you don’t even have to speak; that connection, and eye contact, is all you need to help that person emotionally heal.”

This article first appeared on Medscape.com.

Lillie Shockney, RN, MAS, a two-time breast cancer survivor and adjunct professor at Johns Hopkins School of Nursing in Baltimore, Maryland, mourns the many losses that her patients with advanced cancer now face in the midst of the COVID-19 pandemic. But in the void of the usual support networks and treatment plans, she sees the resurgence of something that has recently been crowded out: hospice.

The pandemic has forced patients and their physicians to reassess the risk/benefit balance of continuing or embarking on yet another cancer treatment.

“It’s one of the pearls that we will get out of this nightmare,” said Ms. Shockney, who recently retired as administrative director of the cancer survivorship programs at the Sidney Kimmel Comprehensive Cancer Center.

“Physicians have been taught to treat the disease – so as long as there’s a treatment they give another treatment,” she told Medscape Medical News during a Zoom call from her home. “But for some patients with advanced disease, those treatments were making them very sick, so they were trading longevity over quality of life.”

Of course, longevity has never been a guarantee with cancer treatment, and even less so now, with the risk of COVID-19.

“This is going to bring them to some hard discussions,” says Brenda Nevidjon, RN, MSN, chief executive officer at the Oncology Nursing Society.

“We’ve known for a long time that there are patients who are on third- and fourth-round treatment options that have very little evidence of prolonging life or quality of life,” she told Medscape Medical News. “Do we bring these people out of their home to a setting where there could be a fair number of COVID-positive patients? Do we expose them to that?”

Across the world, these dilemmas are pushing cancer specialists to initiate discussions of hospice sooner with patients who have advanced disease, and with more clarity than before.

One of the reasons such conversations have often been avoided is that the concept of hospice is generally misunderstood, said Ms. Shockney.

“Patients think ‘you’re giving up on me, you’ve abandoned me’, but hospice is all about preserving the remainder of their quality of life and letting them have time with family and time to fulfill those elements of experiencing a good and peaceful death,” she said.

Indeed, hospice is “a benefit meant for somebody with at least a 6-month horizon,” agrees Ms. Nevidjon. Yet the average length of hospice in the United States is just 5 days. “It’s at the very, very end, and yet for some of these patients the 6 months they could get in hospice might be a better quality of life than the 4 months on another whole plan of chemotherapy. I can’t imagine that on the backside of this pandemic we will not have learned and we won’t start to change practices around initiating more of these conversations.”
 

Silver lining of this pandemic?

It’s too early into the pandemic to have hard data on whether hospice uptake has increased, but “it’s encouraging to hear that hospice is being discussed and offered sooner as an alternative to that third- or fourth-round chemo,” said Lori Bishop, MHA, RN, vice president of palliative and advanced care at the National Hospice and Palliative Care Organization.

“I agree that improving informed-decision discussions and timely access to hospice is a silver lining of the pandemic,” she told Medscape Medical News.

But she points out that today’s hospice looks quite different than it did before the pandemic, with the immediate and very obvious difference being telehealth, which was not widely utilized previously.

In March, the Centers for Medicare & Medicaid Services expanded telehealth options for hospice providers, something that Ms. Bishop and other hospice providers hope will remain in place after the pandemic passes.

“Telehealth visits are offered to replace some in-home visits both to minimize risk of exposure to COVID-19 and reduce the drain on personal protective equipment,” Bishop explained.

“In-patient hospice programs are also finding unique ways to provide support and connect patients to their loved ones: visitors are allowed but limited to one or two. Music and pet therapy are being provided through the window or virtually and devices such as iPads are being used to help patients connect with loved ones,” she said.

Telehealth links patients out of loneliness, but the one thing it cannot do is provide the comfort of touch – an important part of any hospice program.

“Hand-holding ... I miss that a lot,” says Ms. Shockney, her eyes filling with tears. “When you take somebody’s hand, you don’t even have to speak; that connection, and eye contact, is all you need to help that person emotionally heal.”

This article first appeared on Medscape.com.

Lillie Shockney, RN, MAS, a two-time breast cancer survivor and adjunct professor at Johns Hopkins School of Nursing in Baltimore, Maryland, mourns the many losses that her patients with advanced cancer now face in the midst of the COVID-19 pandemic. But in the void of the usual support networks and treatment plans, she sees the resurgence of something that has recently been crowded out: hospice.

The pandemic has forced patients and their physicians to reassess the risk/benefit balance of continuing or embarking on yet another cancer treatment.

“It’s one of the pearls that we will get out of this nightmare,” said Ms. Shockney, who recently retired as administrative director of the cancer survivorship programs at the Sidney Kimmel Comprehensive Cancer Center.

“Physicians have been taught to treat the disease – so as long as there’s a treatment they give another treatment,” she told Medscape Medical News during a Zoom call from her home. “But for some patients with advanced disease, those treatments were making them very sick, so they were trading longevity over quality of life.”

Of course, longevity has never been a guarantee with cancer treatment, and even less so now, with the risk of COVID-19.

“This is going to bring them to some hard discussions,” says Brenda Nevidjon, RN, MSN, chief executive officer at the Oncology Nursing Society.

“We’ve known for a long time that there are patients who are on third- and fourth-round treatment options that have very little evidence of prolonging life or quality of life,” she told Medscape Medical News. “Do we bring these people out of their home to a setting where there could be a fair number of COVID-positive patients? Do we expose them to that?”

Across the world, these dilemmas are pushing cancer specialists to initiate discussions of hospice sooner with patients who have advanced disease, and with more clarity than before.

One of the reasons such conversations have often been avoided is that the concept of hospice is generally misunderstood, said Ms. Shockney.

“Patients think ‘you’re giving up on me, you’ve abandoned me’, but hospice is all about preserving the remainder of their quality of life and letting them have time with family and time to fulfill those elements of experiencing a good and peaceful death,” she said.

Indeed, hospice is “a benefit meant for somebody with at least a 6-month horizon,” agrees Ms. Nevidjon. Yet the average length of hospice in the United States is just 5 days. “It’s at the very, very end, and yet for some of these patients the 6 months they could get in hospice might be a better quality of life than the 4 months on another whole plan of chemotherapy. I can’t imagine that on the backside of this pandemic we will not have learned and we won’t start to change practices around initiating more of these conversations.”
 

Silver lining of this pandemic?

It’s too early into the pandemic to have hard data on whether hospice uptake has increased, but “it’s encouraging to hear that hospice is being discussed and offered sooner as an alternative to that third- or fourth-round chemo,” said Lori Bishop, MHA, RN, vice president of palliative and advanced care at the National Hospice and Palliative Care Organization.

“I agree that improving informed-decision discussions and timely access to hospice is a silver lining of the pandemic,” she told Medscape Medical News.

But she points out that today’s hospice looks quite different than it did before the pandemic, with the immediate and very obvious difference being telehealth, which was not widely utilized previously.

In March, the Centers for Medicare & Medicaid Services expanded telehealth options for hospice providers, something that Ms. Bishop and other hospice providers hope will remain in place after the pandemic passes.

“Telehealth visits are offered to replace some in-home visits both to minimize risk of exposure to COVID-19 and reduce the drain on personal protective equipment,” Bishop explained.

“In-patient hospice programs are also finding unique ways to provide support and connect patients to their loved ones: visitors are allowed but limited to one or two. Music and pet therapy are being provided through the window or virtually and devices such as iPads are being used to help patients connect with loved ones,” she said.

Telehealth links patients out of loneliness, but the one thing it cannot do is provide the comfort of touch – an important part of any hospice program.

“Hand-holding ... I miss that a lot,” says Ms. Shockney, her eyes filling with tears. “When you take somebody’s hand, you don’t even have to speak; that connection, and eye contact, is all you need to help that person emotionally heal.”

This article first appeared on Medscape.com.

More evidence has linked the Kawasaki-like multisystem inflammatory syndrome in children to COVID-19 and suggests that black children have a greater risk of the condition, according to a study published in the BMJ.

A small observational study in Paris found more than half of the 21 children who were admitted for the condition at the city’s pediatric hospital for COVID-19 patients were of African ancestry.

“The observation of a higher proportion of patients of African ancestry is consistent with recent findings, suggesting an effect of either social and living conditions or genetic susceptibility,” wrote Julie Toubiana, MD, PhD, of the University of Paris and the Pasteur Institute, and colleagues.

The findings did not surprise Edward M. Behrens, MD, chief of the division of rheumatology at Children’s Hospital of Philadelphia, whose institution has seen similar disparities that he attributes to social disadvantages.

“Infection rate will be higher in vulnerable populations that are less able to socially distance, have disproportionate numbers of essential workers, and have less access to health care and other resources,” Dr. Behrens said in an interview. “While there may be a role for genetics, environment – including social disparities – is almost certainly playing a role.”

Although the study’s small size is a limitation, he said, “the features described seem to mirror the experience of our center and what has been discussed more broadly amongst U.S. physicians.”

Byron Whyte, MD, a pediatrician in private practice in southeast Washington, found the differences in race interesting, but said the study was too small to draw any conclusions or generalize to the United States. But social disparities related to race are likely similar in France as they are in the United States, he said.

The prospective observational study assessed the clinical and demographic characteristics of all patients under age 18 who met the criteria for Kawasaki disease and were admitted between April 27 and May 20 to the Necker Hospital for Sick Children in Paris.

The 21 children had an average age of 8 years (ranging from 3 to 16), and 57% had at least one parent from sub-Saharan Africa or a Caribbean island; 14% had parents from Asia (two from China and one from Sri Lanka). The authors noted in their discussion that past U.S. and U.K. studies of Kawasaki disease have found a 2.5 times greater risk in Asian-American children and 1.5 times greater risk in African-American children compared with children with European ancestry.

Most of the patients (81%) needed intensive care, with 57% presenting with Kawasaki disease shock syndrome and 67% with myocarditis. Dr. Toubiana and associates also noted that “gastrointestinal symptoms were also unusually common, affecting all of our 21 patients.”

Only nine of the children reported having symptoms of a viral-like illness when they were admitted, primarily headache, cough, coryza, and fever, plus anosmia in one child. Among those children, the Kawasaki symptoms began a median 45 days after onset of the viral symptoms (range 18-79 days).

Only two children showed no positive test result for current COVID-19 infection or antibodies. Eight (38%) of the children had positive PCR tests for SARS-CoV2, and 19 (90%) had positive tests for IgG antibodies. The two patients with both negative tests did not require intensive care and did not have myocarditis.

About half the patients (52%) met all the criteria of Kawasaki disease, and the other 10 had “incomplete Kawasaki disease.” The most common Kawasaki symptoms were the polymorphous skin rash, occurring in 76% of the patients, changes to the lips and oral cavity (76%), and bilateral bulbar conjunctival injection (81%). Three patients (14%) had pleural effusion, and 10 of them (48%) had pericardial effusion, Dr. Toubiana and associates reported.

But Dr. Behrens said he disagrees with the assertion that the illness described in the paper and what he is seeing at Children’s Hospital of Philadelphia is related to Kawasaki disease.

“Most experts here in the U.S. seem to agree this is not Kawasaki disease, but a distinct clinical syndrome called multisystem inflammatory syndrome in children, or MIS-C, that seems to have some overlap with the most nonspecific features of Kawasaki disease,” said Dr. Behrens, who is the Joseph Lee Hollander Chair in Pediatric Rheumatology at Children’s Hospital of Philadelphia. He has coauthored a study currently under review and available as a preprint soon that examines the biologic mechanisms underlying MIS-C.

Neither Dr. Behrens nor Dr. Whyte believed the findings had clinical implications that might change practice, but Dr. Whyte said he will be paying closer attention to the black children he treats – 99% of his practice – who are recovering from COVID-19.

“And, because we know that the concerns of African Americans are often overlooked in health care,” Dr. Whyte said, physicians should “pay a little more attention to symptom reporting on those kids, since there is a possibility that those kids would need hospitalization.”

All the patients in the study were treated with intravenous immunoglobulin, and corticosteroids were administered to 10 of them (48%). Their median hospital stay was 8 days (5 days in intensive care), and all were discharged without any deaths.

“Only one patient had symptoms suggestive of acute covid-19 and most had positive serum test results for IgG antibodies, suggesting that the development of Kawasaki disease in these patients is more likely to be the result of a postviral immunological reaction,” Dr. Toubiana and associates said.

The research received no external funding, and neither the authors nor other quoted physicians had any relevant financial disclosures.

SOURCE: Toubiana J et al. BMJ. 2020 Jun 3, doi: 10.1136 bmj.m2094.

More evidence has linked the Kawasaki-like multisystem inflammatory syndrome in children to COVID-19 and suggests that black children have a greater risk of the condition, according to a study published in the BMJ.

A small observational study in Paris found more than half of the 21 children who were admitted for the condition at the city’s pediatric hospital for COVID-19 patients were of African ancestry.

“The observation of a higher proportion of patients of African ancestry is consistent with recent findings, suggesting an effect of either social and living conditions or genetic susceptibility,” wrote Julie Toubiana, MD, PhD, of the University of Paris and the Pasteur Institute, and colleagues.

The findings did not surprise Edward M. Behrens, MD, chief of the division of rheumatology at Children’s Hospital of Philadelphia, whose institution has seen similar disparities that he attributes to social disadvantages.

“Infection rate will be higher in vulnerable populations that are less able to socially distance, have disproportionate numbers of essential workers, and have less access to health care and other resources,” Dr. Behrens said in an interview. “While there may be a role for genetics, environment – including social disparities – is almost certainly playing a role.”

Although the study’s small size is a limitation, he said, “the features described seem to mirror the experience of our center and what has been discussed more broadly amongst U.S. physicians.”

Byron Whyte, MD, a pediatrician in private practice in southeast Washington, found the differences in race interesting, but said the study was too small to draw any conclusions or generalize to the United States. But social disparities related to race are likely similar in France as they are in the United States, he said.

The prospective observational study assessed the clinical and demographic characteristics of all patients under age 18 who met the criteria for Kawasaki disease and were admitted between April 27 and May 20 to the Necker Hospital for Sick Children in Paris.

The 21 children had an average age of 8 years (ranging from 3 to 16), and 57% had at least one parent from sub-Saharan Africa or a Caribbean island; 14% had parents from Asia (two from China and one from Sri Lanka). The authors noted in their discussion that past U.S. and U.K. studies of Kawasaki disease have found a 2.5 times greater risk in Asian-American children and 1.5 times greater risk in African-American children compared with children with European ancestry.

Most of the patients (81%) needed intensive care, with 57% presenting with Kawasaki disease shock syndrome and 67% with myocarditis. Dr. Toubiana and associates also noted that “gastrointestinal symptoms were also unusually common, affecting all of our 21 patients.”

Only nine of the children reported having symptoms of a viral-like illness when they were admitted, primarily headache, cough, coryza, and fever, plus anosmia in one child. Among those children, the Kawasaki symptoms began a median 45 days after onset of the viral symptoms (range 18-79 days).

Only two children showed no positive test result for current COVID-19 infection or antibodies. Eight (38%) of the children had positive PCR tests for SARS-CoV2, and 19 (90%) had positive tests for IgG antibodies. The two patients with both negative tests did not require intensive care and did not have myocarditis.

About half the patients (52%) met all the criteria of Kawasaki disease, and the other 10 had “incomplete Kawasaki disease.” The most common Kawasaki symptoms were the polymorphous skin rash, occurring in 76% of the patients, changes to the lips and oral cavity (76%), and bilateral bulbar conjunctival injection (81%). Three patients (14%) had pleural effusion, and 10 of them (48%) had pericardial effusion, Dr. Toubiana and associates reported.

But Dr. Behrens said he disagrees with the assertion that the illness described in the paper and what he is seeing at Children’s Hospital of Philadelphia is related to Kawasaki disease.

“Most experts here in the U.S. seem to agree this is not Kawasaki disease, but a distinct clinical syndrome called multisystem inflammatory syndrome in children, or MIS-C, that seems to have some overlap with the most nonspecific features of Kawasaki disease,” said Dr. Behrens, who is the Joseph Lee Hollander Chair in Pediatric Rheumatology at Children’s Hospital of Philadelphia. He has coauthored a study currently under review and available as a preprint soon that examines the biologic mechanisms underlying MIS-C.

Neither Dr. Behrens nor Dr. Whyte believed the findings had clinical implications that might change practice, but Dr. Whyte said he will be paying closer attention to the black children he treats – 99% of his practice – who are recovering from COVID-19.

“And, because we know that the concerns of African Americans are often overlooked in health care,” Dr. Whyte said, physicians should “pay a little more attention to symptom reporting on those kids, since there is a possibility that those kids would need hospitalization.”

All the patients in the study were treated with intravenous immunoglobulin, and corticosteroids were administered to 10 of them (48%). Their median hospital stay was 8 days (5 days in intensive care), and all were discharged without any deaths.

“Only one patient had symptoms suggestive of acute covid-19 and most had positive serum test results for IgG antibodies, suggesting that the development of Kawasaki disease in these patients is more likely to be the result of a postviral immunological reaction,” Dr. Toubiana and associates said.

The research received no external funding, and neither the authors nor other quoted physicians had any relevant financial disclosures.

SOURCE: Toubiana J et al. BMJ. 2020 Jun 3, doi: 10.1136 bmj.m2094.

More evidence has linked the Kawasaki-like multisystem inflammatory syndrome in children to COVID-19 and suggests that black children have a greater risk of the condition, according to a study published in the BMJ.

A small observational study in Paris found more than half of the 21 children who were admitted for the condition at the city’s pediatric hospital for COVID-19 patients were of African ancestry.

“The observation of a higher proportion of patients of African ancestry is consistent with recent findings, suggesting an effect of either social and living conditions or genetic susceptibility,” wrote Julie Toubiana, MD, PhD, of the University of Paris and the Pasteur Institute, and colleagues.

The findings did not surprise Edward M. Behrens, MD, chief of the division of rheumatology at Children’s Hospital of Philadelphia, whose institution has seen similar disparities that he attributes to social disadvantages.

“Infection rate will be higher in vulnerable populations that are less able to socially distance, have disproportionate numbers of essential workers, and have less access to health care and other resources,” Dr. Behrens said in an interview. “While there may be a role for genetics, environment – including social disparities – is almost certainly playing a role.”

Although the study’s small size is a limitation, he said, “the features described seem to mirror the experience of our center and what has been discussed more broadly amongst U.S. physicians.”

Byron Whyte, MD, a pediatrician in private practice in southeast Washington, found the differences in race interesting, but said the study was too small to draw any conclusions or generalize to the United States. But social disparities related to race are likely similar in France as they are in the United States, he said.

The prospective observational study assessed the clinical and demographic characteristics of all patients under age 18 who met the criteria for Kawasaki disease and were admitted between April 27 and May 20 to the Necker Hospital for Sick Children in Paris.

The 21 children had an average age of 8 years (ranging from 3 to 16), and 57% had at least one parent from sub-Saharan Africa or a Caribbean island; 14% had parents from Asia (two from China and one from Sri Lanka). The authors noted in their discussion that past U.S. and U.K. studies of Kawasaki disease have found a 2.5 times greater risk in Asian-American children and 1.5 times greater risk in African-American children compared with children with European ancestry.

Most of the patients (81%) needed intensive care, with 57% presenting with Kawasaki disease shock syndrome and 67% with myocarditis. Dr. Toubiana and associates also noted that “gastrointestinal symptoms were also unusually common, affecting all of our 21 patients.”

Only nine of the children reported having symptoms of a viral-like illness when they were admitted, primarily headache, cough, coryza, and fever, plus anosmia in one child. Among those children, the Kawasaki symptoms began a median 45 days after onset of the viral symptoms (range 18-79 days).

Only two children showed no positive test result for current COVID-19 infection or antibodies. Eight (38%) of the children had positive PCR tests for SARS-CoV2, and 19 (90%) had positive tests for IgG antibodies. The two patients with both negative tests did not require intensive care and did not have myocarditis.

About half the patients (52%) met all the criteria of Kawasaki disease, and the other 10 had “incomplete Kawasaki disease.” The most common Kawasaki symptoms were the polymorphous skin rash, occurring in 76% of the patients, changes to the lips and oral cavity (76%), and bilateral bulbar conjunctival injection (81%). Three patients (14%) had pleural effusion, and 10 of them (48%) had pericardial effusion, Dr. Toubiana and associates reported.

But Dr. Behrens said he disagrees with the assertion that the illness described in the paper and what he is seeing at Children’s Hospital of Philadelphia is related to Kawasaki disease.

“Most experts here in the U.S. seem to agree this is not Kawasaki disease, but a distinct clinical syndrome called multisystem inflammatory syndrome in children, or MIS-C, that seems to have some overlap with the most nonspecific features of Kawasaki disease,” said Dr. Behrens, who is the Joseph Lee Hollander Chair in Pediatric Rheumatology at Children’s Hospital of Philadelphia. He has coauthored a study currently under review and available as a preprint soon that examines the biologic mechanisms underlying MIS-C.

Neither Dr. Behrens nor Dr. Whyte believed the findings had clinical implications that might change practice, but Dr. Whyte said he will be paying closer attention to the black children he treats – 99% of his practice – who are recovering from COVID-19.

“And, because we know that the concerns of African Americans are often overlooked in health care,” Dr. Whyte said, physicians should “pay a little more attention to symptom reporting on those kids, since there is a possibility that those kids would need hospitalization.”

All the patients in the study were treated with intravenous immunoglobulin, and corticosteroids were administered to 10 of them (48%). Their median hospital stay was 8 days (5 days in intensive care), and all were discharged without any deaths.

“Only one patient had symptoms suggestive of acute covid-19 and most had positive serum test results for IgG antibodies, suggesting that the development of Kawasaki disease in these patients is more likely to be the result of a postviral immunological reaction,” Dr. Toubiana and associates said.

The research received no external funding, and neither the authors nor other quoted physicians had any relevant financial disclosures.

SOURCE: Toubiana J et al. BMJ. 2020 Jun 3, doi: 10.1136 bmj.m2094.