Ob.Gyn. News

Use of systemic anticoagulation may improve the chance of survival in patients hospitalized with the COVID-19 virus, a large study from the epicenter of the U.S. outbreak suggests.

Among nearly 3,000 patients with COVID-19 admitted to New York City’s Mount Sinai Health System beginning in mid-March, median survival increased from 14 days to 21 days with the addition of anticoagulation.

The results were particularly striking among sicker patients who required mechanical ventilation, in whom in-hospital mortality fell from 62.7% to 29.1% and median survival jumped from 9 days to 21 days.

Interestingly, the association with anticoagulation and improved survival remained even after adjusting for mechanical ventilation, the authors reported May 6 in the Journal of the American College of Cardiology.

“It’s important for the community to know, first of all, how this should be approached and, second, it’s really opening a door to a new reality,” senior corresponding author Valentin Fuster, MD, PhD, director of Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and JACC editor-in-chief.

“I can tell you any family of mine who will have this disease absolutely will be on antithrombotic therapy and, actually, so are all of the patients at Mount Sinai now,” he said in an interview. COVID-19 is thought to promote thrombosis but the exact role of anticoagulation in the management of COVID-19 and optimal regimen are unknown.

In late March, the International Society on Thrombosis and Haemostasis recommended that all hospitalized COVID-19 patients, even those not in the ICU, should receive prophylactic-dose low-molecular-weight heparin (LMWH), unless they have contraindications.

Last month, international consensus-based recommendations were published for the diagnosis and management of thrombotic disease in patients with COVID-19.

In early March, however, data were scare and only a minimal number of patients were receiving anticoagulants at Mount Sinai.

“But after a few weeks, we reached an intuitive feeling that anticoagulation was of benefit and, at the same time, the literature was beginning to say clots were important in this disease,” Dr. Fuster said. “So we took a very straightforward approach and set up a policy in our institution that all COVID-19 patients should be on antithrombotic therapy. It was a decision made without data, but it was a feeling.”

For the present study, the researchers examined mortality and bleeding among 2,773 patients hospitalized at Mount Sinai with confirmed COVID-19 between March 14 and April 11.

Of these, 786 (28%) received systemic anticoagulation including subcutaneous heparin, LMWH, fractionated heparin, and the novel oral anticoagulants apixaban and dabigatran, for a median of 3 days (range, 2-7 days). Tissue plasminogen activator was also used in some ICU cases.

Major bleeding was defined as hemoglobin less than 7 g/dL and any red blood cell transfusion; at least two units of red blood cell transfusion within 48 hours; or a diagnosis code for major bleeding, notably including intracranial hemorrhage.

Patients treated with anticoagulation were more likely to require invasive mechanical ventilation (29.8% vs. 8.1%) and to have significantly increased prothrombin time, activated partial thromboplastin time, lactate dehydrogenase, ferritin, C-reactive protein, and d-dimer values. In-hospital mortality was 22.5% with anticoagulation and 22.8% without anticoagulation (median survival, 14 days vs. 21 days).

In multivariate analysis, longer anticoagulation duration was associated with a 14% lower adjusted risk of in-hospital death (hazard ratio, 0.86 per day; 95% confidence interval, 0.82-0.89; P < .001).

The model adjusted for several potential confounders such as age, ethnicity, body mass index, and prehospital anticoagulation use. To adjust for differential length of stay and anticoagulation initiation, anticoagulation duration was used as a covariate and intubation was treated as a time-dependent variable.

Bleeding events were similar in patients treated with and without anticoagulation (3% vs. 1.9%; P = .2) but were more common among the 375 intubated patients than among nonintubated patients (7.5% vs. 1.35%; P value not given). “The most important thing was there was no increase in bleeding,” said Dr. Fuster.

Additional support for a possible survival benefit was published April 27 and included 449 patients with severe COVID-19 treated with heparin (mostly LMWH) for at least 7 days in Hunan, China. Overall, 28-day mortality was similar between heparin users and nonusers (30.3% vs. 29.7%) but was significantly lower among heparin users who had a Sepsis-Induced Coagulopathy score of at least 4 (40% vs. 64.2%; P = .02) or d-dimer greater than sixfold the upper limit of normal (32.8% vs. 52.4%; P = .01).

In multivariate analysis, d-dimer, prothrombin time, and age were positively correlated with 28-day mortality, and platelet count was negatively correlated with 28-day mortality.

Victor F. Tapson, MD, who directs the pulmonary embolism response team at Cedars-Sinai Medical Center in Los Angeles and was not involved with the study, said, “The Chinese data were not enough for me to anticoagulate patients therapeutically” but the Mount Sinai data strengthen the case.

“They’re wise to call this a ‘suggestion of improved outcomes,’ but it’s pretty compelling that those patients who were on anticoagulation had improved survival after adjusting for mechanical ventilation,” he said in an interview. “These are sicker patients and sicker patients may get anticoagulated more, but they may bleed more. The bleed risks were a little different but they didn’t seem too concerning.”

“I think this helps move us forward some that we should consider anticoagulating with therapeutic anticoagulation certain patients that meet certain criteria,” Dr. Tapson said. “An easy example is a patient who comes to the hospital, has active cancer and is on a DOAC [direct oral anticoagulant], and comes up with COVID.”

At the same time, some clinicians want to increase prophylactic anticoagulation “using enoxaparin 40 mg once a day and maybe go to twice a day – not quite therapeutic doses but increased prophylaxis,” he observed. Anticoagulation was given at “relatively low doses” in the Mount Sinai study but that is evolving in light of the reassuring bleeding data, Dr. Fuster said. They now have three enoxaparin regimens and, for example, give patients who don’t require intensive care enoxaparin 30 mg twice a day, up from 40 mg a day initially.

Patients are also stratified by factors such as renal failure and obesity, creating an intermediate group between those not initially needing intensive care and ICU cases.

In the coming weeks, the researchers will evaluate anticoagulation regimens and a broader array of outcomes among 5,000 patients, two-thirds of whom received anticoagulation after Mount Sinai enacted its anticoagulation policy. “We’re now going to look at the difference between all these [regimens],” Dr. Fuster said. “My personal feeling and, for feasibility issues, I hope the winner is subcutaneous heparin.”

Three randomized trials are also planned. “Three questions we really want to ask are: what to give in the hospital, what to give those who go home after the hospital, and what to give those who are not hospitalized,” he said.

The work was supported by U54 TR001433-05, National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Fuster has disclosed no relevant financial relationships. Dr. Tapson reported consulting and clinical trial work for BMS, Janssen, Daiichi Medical, ECOS/BTG, Inari, and Penumbra.

A version of this article originally appeared on Medscape.com.

Use of systemic anticoagulation may improve the chance of survival in patients hospitalized with the COVID-19 virus, a large study from the epicenter of the U.S. outbreak suggests.

Among nearly 3,000 patients with COVID-19 admitted to New York City’s Mount Sinai Health System beginning in mid-March, median survival increased from 14 days to 21 days with the addition of anticoagulation.

The results were particularly striking among sicker patients who required mechanical ventilation, in whom in-hospital mortality fell from 62.7% to 29.1% and median survival jumped from 9 days to 21 days.

Interestingly, the association with anticoagulation and improved survival remained even after adjusting for mechanical ventilation, the authors reported May 6 in the Journal of the American College of Cardiology.

“It’s important for the community to know, first of all, how this should be approached and, second, it’s really opening a door to a new reality,” senior corresponding author Valentin Fuster, MD, PhD, director of Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and JACC editor-in-chief.

“I can tell you any family of mine who will have this disease absolutely will be on antithrombotic therapy and, actually, so are all of the patients at Mount Sinai now,” he said in an interview. COVID-19 is thought to promote thrombosis but the exact role of anticoagulation in the management of COVID-19 and optimal regimen are unknown.

In late March, the International Society on Thrombosis and Haemostasis recommended that all hospitalized COVID-19 patients, even those not in the ICU, should receive prophylactic-dose low-molecular-weight heparin (LMWH), unless they have contraindications.

Last month, international consensus-based recommendations were published for the diagnosis and management of thrombotic disease in patients with COVID-19.

In early March, however, data were scare and only a minimal number of patients were receiving anticoagulants at Mount Sinai.

“But after a few weeks, we reached an intuitive feeling that anticoagulation was of benefit and, at the same time, the literature was beginning to say clots were important in this disease,” Dr. Fuster said. “So we took a very straightforward approach and set up a policy in our institution that all COVID-19 patients should be on antithrombotic therapy. It was a decision made without data, but it was a feeling.”

For the present study, the researchers examined mortality and bleeding among 2,773 patients hospitalized at Mount Sinai with confirmed COVID-19 between March 14 and April 11.

Of these, 786 (28%) received systemic anticoagulation including subcutaneous heparin, LMWH, fractionated heparin, and the novel oral anticoagulants apixaban and dabigatran, for a median of 3 days (range, 2-7 days). Tissue plasminogen activator was also used in some ICU cases.

Major bleeding was defined as hemoglobin less than 7 g/dL and any red blood cell transfusion; at least two units of red blood cell transfusion within 48 hours; or a diagnosis code for major bleeding, notably including intracranial hemorrhage.

Patients treated with anticoagulation were more likely to require invasive mechanical ventilation (29.8% vs. 8.1%) and to have significantly increased prothrombin time, activated partial thromboplastin time, lactate dehydrogenase, ferritin, C-reactive protein, and d-dimer values. In-hospital mortality was 22.5% with anticoagulation and 22.8% without anticoagulation (median survival, 14 days vs. 21 days).

In multivariate analysis, longer anticoagulation duration was associated with a 14% lower adjusted risk of in-hospital death (hazard ratio, 0.86 per day; 95% confidence interval, 0.82-0.89; P < .001).

The model adjusted for several potential confounders such as age, ethnicity, body mass index, and prehospital anticoagulation use. To adjust for differential length of stay and anticoagulation initiation, anticoagulation duration was used as a covariate and intubation was treated as a time-dependent variable.

Bleeding events were similar in patients treated with and without anticoagulation (3% vs. 1.9%; P = .2) but were more common among the 375 intubated patients than among nonintubated patients (7.5% vs. 1.35%; P value not given). “The most important thing was there was no increase in bleeding,” said Dr. Fuster.

Additional support for a possible survival benefit was published April 27 and included 449 patients with severe COVID-19 treated with heparin (mostly LMWH) for at least 7 days in Hunan, China. Overall, 28-day mortality was similar between heparin users and nonusers (30.3% vs. 29.7%) but was significantly lower among heparin users who had a Sepsis-Induced Coagulopathy score of at least 4 (40% vs. 64.2%; P = .02) or d-dimer greater than sixfold the upper limit of normal (32.8% vs. 52.4%; P = .01).

In multivariate analysis, d-dimer, prothrombin time, and age were positively correlated with 28-day mortality, and platelet count was negatively correlated with 28-day mortality.

Victor F. Tapson, MD, who directs the pulmonary embolism response team at Cedars-Sinai Medical Center in Los Angeles and was not involved with the study, said, “The Chinese data were not enough for me to anticoagulate patients therapeutically” but the Mount Sinai data strengthen the case.

“They’re wise to call this a ‘suggestion of improved outcomes,’ but it’s pretty compelling that those patients who were on anticoagulation had improved survival after adjusting for mechanical ventilation,” he said in an interview. “These are sicker patients and sicker patients may get anticoagulated more, but they may bleed more. The bleed risks were a little different but they didn’t seem too concerning.”

“I think this helps move us forward some that we should consider anticoagulating with therapeutic anticoagulation certain patients that meet certain criteria,” Dr. Tapson said. “An easy example is a patient who comes to the hospital, has active cancer and is on a DOAC [direct oral anticoagulant], and comes up with COVID.”

At the same time, some clinicians want to increase prophylactic anticoagulation “using enoxaparin 40 mg once a day and maybe go to twice a day – not quite therapeutic doses but increased prophylaxis,” he observed. Anticoagulation was given at “relatively low doses” in the Mount Sinai study but that is evolving in light of the reassuring bleeding data, Dr. Fuster said. They now have three enoxaparin regimens and, for example, give patients who don’t require intensive care enoxaparin 30 mg twice a day, up from 40 mg a day initially.

Patients are also stratified by factors such as renal failure and obesity, creating an intermediate group between those not initially needing intensive care and ICU cases.

In the coming weeks, the researchers will evaluate anticoagulation regimens and a broader array of outcomes among 5,000 patients, two-thirds of whom received anticoagulation after Mount Sinai enacted its anticoagulation policy. “We’re now going to look at the difference between all these [regimens],” Dr. Fuster said. “My personal feeling and, for feasibility issues, I hope the winner is subcutaneous heparin.”

Three randomized trials are also planned. “Three questions we really want to ask are: what to give in the hospital, what to give those who go home after the hospital, and what to give those who are not hospitalized,” he said.

The work was supported by U54 TR001433-05, National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Fuster has disclosed no relevant financial relationships. Dr. Tapson reported consulting and clinical trial work for BMS, Janssen, Daiichi Medical, ECOS/BTG, Inari, and Penumbra.

A version of this article originally appeared on Medscape.com.

Use of systemic anticoagulation may improve the chance of survival in patients hospitalized with the COVID-19 virus, a large study from the epicenter of the U.S. outbreak suggests.

Among nearly 3,000 patients with COVID-19 admitted to New York City’s Mount Sinai Health System beginning in mid-March, median survival increased from 14 days to 21 days with the addition of anticoagulation.

The results were particularly striking among sicker patients who required mechanical ventilation, in whom in-hospital mortality fell from 62.7% to 29.1% and median survival jumped from 9 days to 21 days.

Interestingly, the association with anticoagulation and improved survival remained even after adjusting for mechanical ventilation, the authors reported May 6 in the Journal of the American College of Cardiology.

“It’s important for the community to know, first of all, how this should be approached and, second, it’s really opening a door to a new reality,” senior corresponding author Valentin Fuster, MD, PhD, director of Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and JACC editor-in-chief.

“I can tell you any family of mine who will have this disease absolutely will be on antithrombotic therapy and, actually, so are all of the patients at Mount Sinai now,” he said in an interview. COVID-19 is thought to promote thrombosis but the exact role of anticoagulation in the management of COVID-19 and optimal regimen are unknown.

In late March, the International Society on Thrombosis and Haemostasis recommended that all hospitalized COVID-19 patients, even those not in the ICU, should receive prophylactic-dose low-molecular-weight heparin (LMWH), unless they have contraindications.

Last month, international consensus-based recommendations were published for the diagnosis and management of thrombotic disease in patients with COVID-19.

In early March, however, data were scare and only a minimal number of patients were receiving anticoagulants at Mount Sinai.

“But after a few weeks, we reached an intuitive feeling that anticoagulation was of benefit and, at the same time, the literature was beginning to say clots were important in this disease,” Dr. Fuster said. “So we took a very straightforward approach and set up a policy in our institution that all COVID-19 patients should be on antithrombotic therapy. It was a decision made without data, but it was a feeling.”

For the present study, the researchers examined mortality and bleeding among 2,773 patients hospitalized at Mount Sinai with confirmed COVID-19 between March 14 and April 11.

Of these, 786 (28%) received systemic anticoagulation including subcutaneous heparin, LMWH, fractionated heparin, and the novel oral anticoagulants apixaban and dabigatran, for a median of 3 days (range, 2-7 days). Tissue plasminogen activator was also used in some ICU cases.

Major bleeding was defined as hemoglobin less than 7 g/dL and any red blood cell transfusion; at least two units of red blood cell transfusion within 48 hours; or a diagnosis code for major bleeding, notably including intracranial hemorrhage.

Patients treated with anticoagulation were more likely to require invasive mechanical ventilation (29.8% vs. 8.1%) and to have significantly increased prothrombin time, activated partial thromboplastin time, lactate dehydrogenase, ferritin, C-reactive protein, and d-dimer values. In-hospital mortality was 22.5% with anticoagulation and 22.8% without anticoagulation (median survival, 14 days vs. 21 days).

In multivariate analysis, longer anticoagulation duration was associated with a 14% lower adjusted risk of in-hospital death (hazard ratio, 0.86 per day; 95% confidence interval, 0.82-0.89; P < .001).

The model adjusted for several potential confounders such as age, ethnicity, body mass index, and prehospital anticoagulation use. To adjust for differential length of stay and anticoagulation initiation, anticoagulation duration was used as a covariate and intubation was treated as a time-dependent variable.

Bleeding events were similar in patients treated with and without anticoagulation (3% vs. 1.9%; P = .2) but were more common among the 375 intubated patients than among nonintubated patients (7.5% vs. 1.35%; P value not given). “The most important thing was there was no increase in bleeding,” said Dr. Fuster.

Additional support for a possible survival benefit was published April 27 and included 449 patients with severe COVID-19 treated with heparin (mostly LMWH) for at least 7 days in Hunan, China. Overall, 28-day mortality was similar between heparin users and nonusers (30.3% vs. 29.7%) but was significantly lower among heparin users who had a Sepsis-Induced Coagulopathy score of at least 4 (40% vs. 64.2%; P = .02) or d-dimer greater than sixfold the upper limit of normal (32.8% vs. 52.4%; P = .01).

In multivariate analysis, d-dimer, prothrombin time, and age were positively correlated with 28-day mortality, and platelet count was negatively correlated with 28-day mortality.

Victor F. Tapson, MD, who directs the pulmonary embolism response team at Cedars-Sinai Medical Center in Los Angeles and was not involved with the study, said, “The Chinese data were not enough for me to anticoagulate patients therapeutically” but the Mount Sinai data strengthen the case.

“They’re wise to call this a ‘suggestion of improved outcomes,’ but it’s pretty compelling that those patients who were on anticoagulation had improved survival after adjusting for mechanical ventilation,” he said in an interview. “These are sicker patients and sicker patients may get anticoagulated more, but they may bleed more. The bleed risks were a little different but they didn’t seem too concerning.”

“I think this helps move us forward some that we should consider anticoagulating with therapeutic anticoagulation certain patients that meet certain criteria,” Dr. Tapson said. “An easy example is a patient who comes to the hospital, has active cancer and is on a DOAC [direct oral anticoagulant], and comes up with COVID.”

At the same time, some clinicians want to increase prophylactic anticoagulation “using enoxaparin 40 mg once a day and maybe go to twice a day – not quite therapeutic doses but increased prophylaxis,” he observed. Anticoagulation was given at “relatively low doses” in the Mount Sinai study but that is evolving in light of the reassuring bleeding data, Dr. Fuster said. They now have three enoxaparin regimens and, for example, give patients who don’t require intensive care enoxaparin 30 mg twice a day, up from 40 mg a day initially.

Patients are also stratified by factors such as renal failure and obesity, creating an intermediate group between those not initially needing intensive care and ICU cases.

In the coming weeks, the researchers will evaluate anticoagulation regimens and a broader array of outcomes among 5,000 patients, two-thirds of whom received anticoagulation after Mount Sinai enacted its anticoagulation policy. “We’re now going to look at the difference between all these [regimens],” Dr. Fuster said. “My personal feeling and, for feasibility issues, I hope the winner is subcutaneous heparin.”

Three randomized trials are also planned. “Three questions we really want to ask are: what to give in the hospital, what to give those who go home after the hospital, and what to give those who are not hospitalized,” he said.

The work was supported by U54 TR001433-05, National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Fuster has disclosed no relevant financial relationships. Dr. Tapson reported consulting and clinical trial work for BMS, Janssen, Daiichi Medical, ECOS/BTG, Inari, and Penumbra.

A version of this article originally appeared on Medscape.com.

No form of human misery can be allowed to go unexploited, and the pandemic, it seems, is no exception.

As part of Operation Quack Hack, the Food and Drug Administration has stepped up its investigation and enforcement efforts against companies and individuals that are “taking advantage of widespread fear among consumers during the COVID-19 pandemic” by selling fake products and treatments for coronavirus.

As of May 7, 2020, the agency had issued 42 warning letters to companies that were “selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19,” the FDA announced in a written statement. Of those 42 products, 29 are no longer being sold with any sort of COVID-19 claim.

Since the beginning of the pandemic, Operation Quack Hack has uncovered hundreds of such products – drugs, testing kits, and personal protective equipment – being sold online, and complaints were sent to domain-name registrars and Internet marketplaces that have, in most cases, removed the postings, the FDA said.

“We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the statement said.

rfranki@mdedge.com

No form of human misery can be allowed to go unexploited, and the pandemic, it seems, is no exception.

As part of Operation Quack Hack, the Food and Drug Administration has stepped up its investigation and enforcement efforts against companies and individuals that are “taking advantage of widespread fear among consumers during the COVID-19 pandemic” by selling fake products and treatments for coronavirus.

As of May 7, 2020, the agency had issued 42 warning letters to companies that were “selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19,” the FDA announced in a written statement. Of those 42 products, 29 are no longer being sold with any sort of COVID-19 claim.

Since the beginning of the pandemic, Operation Quack Hack has uncovered hundreds of such products – drugs, testing kits, and personal protective equipment – being sold online, and complaints were sent to domain-name registrars and Internet marketplaces that have, in most cases, removed the postings, the FDA said.

“We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the statement said.

rfranki@mdedge.com

No form of human misery can be allowed to go unexploited, and the pandemic, it seems, is no exception.

As part of Operation Quack Hack, the Food and Drug Administration has stepped up its investigation and enforcement efforts against companies and individuals that are “taking advantage of widespread fear among consumers during the COVID-19 pandemic” by selling fake products and treatments for coronavirus.

As of May 7, 2020, the agency had issued 42 warning letters to companies that were “selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19,” the FDA announced in a written statement. Of those 42 products, 29 are no longer being sold with any sort of COVID-19 claim.

Since the beginning of the pandemic, Operation Quack Hack has uncovered hundreds of such products – drugs, testing kits, and personal protective equipment – being sold online, and complaints were sent to domain-name registrars and Internet marketplaces that have, in most cases, removed the postings, the FDA said.

“We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the statement said.

rfranki@mdedge.com

An additional 75,000 Americans could die by suicide, drugs, or alcohol abuse because of the COVID-19 pandemic, projections from a new national report released today suggest.

The number of “deaths of despair” could be even higher if the country fails to take bold action to address the mental health toll of unemployment, isolation, and uncertainty, according to the report from the Well Being Trust (WBT) and the Robert Graham Center for Policy Studies in Family Medicine and Primary Care.

“If nothing happens and nothing improves – ie, the worst-case scenario – we could be looking at an additional 150,000 people who died who didn’t have to,” Benjamin Miller, PsyD, WBT chief strategy officer, told Medscape Medical News.

“We can prevent these deaths. We know how and have a bevy of evidence-based solutions. We lack the resources to really stand this up in a way that can most positively impact communities,” Miller added.

Slow recovery, quick recovery scenarios

For the analysis, Miller and colleagues combined information on the number of deaths from suicide, alcohol, and drugs from 2018 as a baseline (n = 181,686). They projected levels of unemployment from 2020 to 2029 and then used economic modeling to estimate the additional annual number of deaths.

Across nine different scenarios, the number of additional deaths of despair range from 27,644 (quick recovery, smallest impact of unemployment on suicide, alcohol-, and drug-related deaths) to 154,037 (slow recovery, greatest impact of unemployment on these deaths), with 75,000 being the most likely.

The report offers several policy solutions to prevent a surge in “avoidable” deaths. They include finding ways to ameliorate the effects of unemployment and provide meaningful work to those who are out of work. Making access to care easier and fully integrating mental health and addiction care into primary and clinical care as well as community settings are also essential.

These solutions should also serve to prevent drug and alcohol misuse and suicide in normal times, the researchers say.

Miller believes it’s time for the federal government to fully support a framework of excellence in mental health and well-being and to invest in mental health now.

“In the short term, we need at least $48 billion to keep the lights on in the current system,” he said.

“This is because 92.6% of mental health organizations have had to reduce their operations in some capacity, 61.8% have had to completely close at least one program, and 31.0% have had to turn away patients. This scenario is not optimal for people who will need a system to help them right now during a crisis,” he added.

In the long term, $150 billion is needed for a “massive structural redesign” of the US mental health system, Miller said.

“This means bringing mental health fully into all facets of our healthcare system, of our community. It will take robust investment in creating new mechanisms for care ― those that are team-based, create a new type of workforce to deliver that care, and one that is seamless across clinical and community settings,” said Miller.

A version of this article first appeared on Medscape.com.

An additional 75,000 Americans could die by suicide, drugs, or alcohol abuse because of the COVID-19 pandemic, projections from a new national report released today suggest.

The number of “deaths of despair” could be even higher if the country fails to take bold action to address the mental health toll of unemployment, isolation, and uncertainty, according to the report from the Well Being Trust (WBT) and the Robert Graham Center for Policy Studies in Family Medicine and Primary Care.

“If nothing happens and nothing improves – ie, the worst-case scenario – we could be looking at an additional 150,000 people who died who didn’t have to,” Benjamin Miller, PsyD, WBT chief strategy officer, told Medscape Medical News.

“We can prevent these deaths. We know how and have a bevy of evidence-based solutions. We lack the resources to really stand this up in a way that can most positively impact communities,” Miller added.

Slow recovery, quick recovery scenarios

For the analysis, Miller and colleagues combined information on the number of deaths from suicide, alcohol, and drugs from 2018 as a baseline (n = 181,686). They projected levels of unemployment from 2020 to 2029 and then used economic modeling to estimate the additional annual number of deaths.

Across nine different scenarios, the number of additional deaths of despair range from 27,644 (quick recovery, smallest impact of unemployment on suicide, alcohol-, and drug-related deaths) to 154,037 (slow recovery, greatest impact of unemployment on these deaths), with 75,000 being the most likely.

The report offers several policy solutions to prevent a surge in “avoidable” deaths. They include finding ways to ameliorate the effects of unemployment and provide meaningful work to those who are out of work. Making access to care easier and fully integrating mental health and addiction care into primary and clinical care as well as community settings are also essential.

These solutions should also serve to prevent drug and alcohol misuse and suicide in normal times, the researchers say.

Miller believes it’s time for the federal government to fully support a framework of excellence in mental health and well-being and to invest in mental health now.

“In the short term, we need at least $48 billion to keep the lights on in the current system,” he said.

“This is because 92.6% of mental health organizations have had to reduce their operations in some capacity, 61.8% have had to completely close at least one program, and 31.0% have had to turn away patients. This scenario is not optimal for people who will need a system to help them right now during a crisis,” he added.

In the long term, $150 billion is needed for a “massive structural redesign” of the US mental health system, Miller said.

“This means bringing mental health fully into all facets of our healthcare system, of our community. It will take robust investment in creating new mechanisms for care ― those that are team-based, create a new type of workforce to deliver that care, and one that is seamless across clinical and community settings,” said Miller.

A version of this article first appeared on Medscape.com.

An additional 75,000 Americans could die by suicide, drugs, or alcohol abuse because of the COVID-19 pandemic, projections from a new national report released today suggest.

The number of “deaths of despair” could be even higher if the country fails to take bold action to address the mental health toll of unemployment, isolation, and uncertainty, according to the report from the Well Being Trust (WBT) and the Robert Graham Center for Policy Studies in Family Medicine and Primary Care.

“If nothing happens and nothing improves – ie, the worst-case scenario – we could be looking at an additional 150,000 people who died who didn’t have to,” Benjamin Miller, PsyD, WBT chief strategy officer, told Medscape Medical News.

“We can prevent these deaths. We know how and have a bevy of evidence-based solutions. We lack the resources to really stand this up in a way that can most positively impact communities,” Miller added.

Slow recovery, quick recovery scenarios

For the analysis, Miller and colleagues combined information on the number of deaths from suicide, alcohol, and drugs from 2018 as a baseline (n = 181,686). They projected levels of unemployment from 2020 to 2029 and then used economic modeling to estimate the additional annual number of deaths.

Across nine different scenarios, the number of additional deaths of despair range from 27,644 (quick recovery, smallest impact of unemployment on suicide, alcohol-, and drug-related deaths) to 154,037 (slow recovery, greatest impact of unemployment on these deaths), with 75,000 being the most likely.

The report offers several policy solutions to prevent a surge in “avoidable” deaths. They include finding ways to ameliorate the effects of unemployment and provide meaningful work to those who are out of work. Making access to care easier and fully integrating mental health and addiction care into primary and clinical care as well as community settings are also essential.

These solutions should also serve to prevent drug and alcohol misuse and suicide in normal times, the researchers say.

Miller believes it’s time for the federal government to fully support a framework of excellence in mental health and well-being and to invest in mental health now.

“In the short term, we need at least $48 billion to keep the lights on in the current system,” he said.

“This is because 92.6% of mental health organizations have had to reduce their operations in some capacity, 61.8% have had to completely close at least one program, and 31.0% have had to turn away patients. This scenario is not optimal for people who will need a system to help them right now during a crisis,” he added.

In the long term, $150 billion is needed for a “massive structural redesign” of the US mental health system, Miller said.

“This means bringing mental health fully into all facets of our healthcare system, of our community. It will take robust investment in creating new mechanisms for care ― those that are team-based, create a new type of workforce to deliver that care, and one that is seamless across clinical and community settings,” said Miller.

A version of this article first appeared on Medscape.com.

A novel clinical presentation in children involving symptoms seen with atypical Kawasaki disease and toxic shock syndrome may be linked to COVID-19 infection, according to reports from National Health Service England, The Lancet, and the New York City health department.

Courtesy NIAID-RML

Fifteen children in New York City hospitals have presented with the condition, provisionally called pediatric multisystem inflammatory syndrome, between April 17 and May 1, according to a health alert from New York City health department deputy commissioner Demetre C. Daskalakis, MD, MPH, on May 4. On May 5, the New York state department of health released a health advisory that 64 suspected cases had been reported in children in New York state hospitals, including New York City.

The New York City reports follow a case study published April 7 in Hospital Pediatrics about the presentation. There also was a statement from the U.K.’s Paediatric Intensive Care Society (PICS) on April 27 that noted “blood parameters consistent with severe COVID-19 in children” as well as abdominal pain, gastrointestinal symptoms, and cardiac inflammation.

“Whilst it is too early to say with confidence, features appear to include high CRP [C-reactive protein], high [erythrocyte sedimentation rate] and high ferritin,” the PICS release stated. The cardiac inflammation consists of “myocarditis with raised troponin and [prohormone brain natriuretic peptide],” according to the PICS statement. “Some have an appearance of their coronary arteries in keeping with Kawasaki disease.”

The initial 15 New York City patients reportedly all had “subjective or measured fever, and more than half reported rash, abdominal pain, vomiting, or diarrhea,” but fewer than half had respiratory symptoms.

The case study described a 6-month-old infant who was admitted and diagnosed with classic Kawasaki disease, who also tested positive for COVID-19 with fever and mild respiratory symptoms, reported Veena G. Jones, MD, a pediatric hospitalist in Palo Alto, Calif., and associates.

While many of the U.K. children presenting with the symptoms had a positive polymerase chain reaction tests for infection from SARS-CoV-2, some also had a negative test. Polymerase chain reaction testing in New York City was positive for 4 children and negative for 11 children, but 6 of the those who tested negative had positive serology tests, potentially pointing to postinfection sequelae.

At press time, more cases were reported from the United Kingdom in The Lancet. In London, eight children with hyperinflammatory shock, showing features similar to atypical Kawasaki disease, Kawasaki disease shock syndrome, or toxic shock syndrome, presented within 10 days to Evelina London Children’s Hospital Paediatric ICU, Shelley Riphagen, MBChB, and colleagues revealed.

Clinically, their presentations were similar, with persistent fever, rash, conjunctivitis, peripheral edema, extremity pain, and gastrointestinal symptoms. They all developed warm vasoplegic shock that did not respond to volume resuscitation; noradrenaline and milrinone were administered for hemodynamic support. Seven of the children needed mechanical ventilation for cardiovascular stabilization, although most of them had no significant respiratory involvement.

Of note was development of small pleural, pericardial, and ascitic effusion – “suggestive of a diffuse inflammatory process,” Dr. Riphagen and associates wrote. None of the children initially was positive for SARS-CoV-2; laboratory evidence of infection or inflammation included “elevated concentrations of CRP, procalcitonin, ferritin, triglycerides or d-dimers.”

“A common echocardiographic finding was echobright coronary vessels,” they wrote. “One child developed arrhythmia with refractory shock, requiring extracorporeal life support, and died from a large cerebrovascular infarct.”

As the article went to press, the doctors in that same ICU had seen more than 20 children with similar clinical presentations, Dr. Riphagen and associates reported, and the first 10 tested positive for SARS-CoV-2 antibody, including the 8 described above.

“Most of the children appear to have antibodies to the novel coronavirus, even when they do not have virus detectable in their nose,” said Audrey John, MD, PhD, chief of the division of pediatric infectious diseases at Children’s Hospital of Philadelphia, where clinicians have seen several cases similar to those described by NHS England and the New York City health department. “This suggests that these symptoms are ‘postinfectious,’ likely due to an abnormal immune response that happens after viral infection.”

She noted at the time of her interview, however, that fewer than 100 U.S. pediatric cases appear to have been reported.

“While our understanding is evolving, given the scope of the COVID-19 pandemic, this suggests that this kind of severe disease in children is very rare indeed,” Dr. John said. “Because this syndrome is so newly described, we have to continue to be cautious in attributing this syndrome to COVID-19, as there are many other diseases that look quite similar.”

She advised clinicians to be “wary of attributing fever/rash/shock to this syndrome, as the differential is broad, and we do not want to fail to recognize and treat true toxic shock or tick-borne disease.”

Dawn Nolt, MD, MPH, an associate professor of pediatrics in infectious diseases at Oregon Health & Science University’s Doernbecher Children’s Hospital, Portland, also underscored the need to avoid drawing conclusions too quickly.

“At this time, there is no causality established between SARS-COV-2 and these inflammatory syndromes other than a temporal association,” said Dr. Nolt, whose hospital has not yet seen any of these cases. “If there is a link, then the symptoms may be from a ‘direct hit’ of the virus on tissues, or from an overly exuberant immune response.”

None of the initial 15 New York City children died, although 5 needed mechanical ventilation and over half needed blood pressure support. The one child in London died from a large cerebrovascular infarct.

If the cases are connected to COVID-19, one explanation for the presentation may be related to the leading hypothesis “that SARS-CoV-2 may stimulate the immune system in such a way to promote vasculitis,” Dr. Nolt said in an interview.

“It is unusual that this particular constellation was not reported from the known pediatric cases out of China, where the COVID-19 pandemic originated,” Dr. Nolt said. “If there is a link between SARS-CoV-2 and these inflammatory syndromes, this may have resulted from genetic/host differences, changes in the SARS-CoV-2 virus, or other factors yet to be determined.”

The New York City bulletin recommended that clinicians immediately refer children presenting with the described symptoms to a specialist in pediatric infectious disease, rheumatology, or critical care.

“Early diagnosis and treatment of patients meeting full or partial criteria for Kawasaki disease is critical to preventing end-organ damage and other long-term complications,” the bulletin stated. It recommended aspirin and intravenous immunoglobulin for those who met Kawasaki criteria.

Dr. John said that children with the presentation appear to be responding well to intravenous immunoglobulin and/or steroids. She further emphasized that virtually all pediatric patients recover from COVID-19.

“Physicians should advise families to bring their children and teens back in for evaluation if they develop new fever, rash, or abdominal pain and diarrhea,” Dr. John said. “Families should not be afraid to seek care when their kids are sick. Our pediatric hospitals and EDs are open for business and working hard to protect staff and patients.”

A Kawasaki syndrome diagnosis requires at least 5 days of a fever at 101-104° F or higher along with four of the following five symptoms: rash over the torso; redness and swelling on palms and soles of the feet with later skin peeling; bloodshot, light-sensitive eyes; swollen lymph glands in the neck; and irritation and inflammation of the mouth, lips and throat, sometimes with “strawberry” tongue, according to the American Heart Association.

A press release from the AHA noted that Kawasaki disease is the most common cause of acquired heart disease in developed countries, but the condition remains rare.

Kawasaki disease’s etiology is unknown, but “some evidence suggests an infectious trigger, with winter-spring seasonality of the disease,” wrote the case study authors, noting that past research has linked Kawasaki disease with previous or concurrent infections of rhinovirus/enterovirus, parainfluenza, respiratory syncytial virus, influenza, adenovirus, and the four common human coronavirus strains.

“We have to remember that our experience with this pandemic is less than 12 months,” Dr. Nolt said. “We are still accumulating information, and any additional manifestations, particularly severe ones, adds to our ability to more quickly detect and treat children.”

Dr. Nolt and Dr. John had no disclosures.

SOURCES: Jones VG et al. Hosp Pediatr. 2020 Apr 7. doi: 10.1542/hpeds.2020-0123; Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.

A novel clinical presentation in children involving symptoms seen with atypical Kawasaki disease and toxic shock syndrome may be linked to COVID-19 infection, according to reports from National Health Service England, The Lancet, and the New York City health department.

Courtesy NIAID-RML

Fifteen children in New York City hospitals have presented with the condition, provisionally called pediatric multisystem inflammatory syndrome, between April 17 and May 1, according to a health alert from New York City health department deputy commissioner Demetre C. Daskalakis, MD, MPH, on May 4. On May 5, the New York state department of health released a health advisory that 64 suspected cases had been reported in children in New York state hospitals, including New York City.

The New York City reports follow a case study published April 7 in Hospital Pediatrics about the presentation. There also was a statement from the U.K.’s Paediatric Intensive Care Society (PICS) on April 27 that noted “blood parameters consistent with severe COVID-19 in children” as well as abdominal pain, gastrointestinal symptoms, and cardiac inflammation.

“Whilst it is too early to say with confidence, features appear to include high CRP [C-reactive protein], high [erythrocyte sedimentation rate] and high ferritin,” the PICS release stated. The cardiac inflammation consists of “myocarditis with raised troponin and [prohormone brain natriuretic peptide],” according to the PICS statement. “Some have an appearance of their coronary arteries in keeping with Kawasaki disease.”

The initial 15 New York City patients reportedly all had “subjective or measured fever, and more than half reported rash, abdominal pain, vomiting, or diarrhea,” but fewer than half had respiratory symptoms.

The case study described a 6-month-old infant who was admitted and diagnosed with classic Kawasaki disease, who also tested positive for COVID-19 with fever and mild respiratory symptoms, reported Veena G. Jones, MD, a pediatric hospitalist in Palo Alto, Calif., and associates.

While many of the U.K. children presenting with the symptoms had a positive polymerase chain reaction tests for infection from SARS-CoV-2, some also had a negative test. Polymerase chain reaction testing in New York City was positive for 4 children and negative for 11 children, but 6 of the those who tested negative had positive serology tests, potentially pointing to postinfection sequelae.

At press time, more cases were reported from the United Kingdom in The Lancet. In London, eight children with hyperinflammatory shock, showing features similar to atypical Kawasaki disease, Kawasaki disease shock syndrome, or toxic shock syndrome, presented within 10 days to Evelina London Children’s Hospital Paediatric ICU, Shelley Riphagen, MBChB, and colleagues revealed.

Clinically, their presentations were similar, with persistent fever, rash, conjunctivitis, peripheral edema, extremity pain, and gastrointestinal symptoms. They all developed warm vasoplegic shock that did not respond to volume resuscitation; noradrenaline and milrinone were administered for hemodynamic support. Seven of the children needed mechanical ventilation for cardiovascular stabilization, although most of them had no significant respiratory involvement.

Of note was development of small pleural, pericardial, and ascitic effusion – “suggestive of a diffuse inflammatory process,” Dr. Riphagen and associates wrote. None of the children initially was positive for SARS-CoV-2; laboratory evidence of infection or inflammation included “elevated concentrations of CRP, procalcitonin, ferritin, triglycerides or d-dimers.”

“A common echocardiographic finding was echobright coronary vessels,” they wrote. “One child developed arrhythmia with refractory shock, requiring extracorporeal life support, and died from a large cerebrovascular infarct.”

As the article went to press, the doctors in that same ICU had seen more than 20 children with similar clinical presentations, Dr. Riphagen and associates reported, and the first 10 tested positive for SARS-CoV-2 antibody, including the 8 described above.

“Most of the children appear to have antibodies to the novel coronavirus, even when they do not have virus detectable in their nose,” said Audrey John, MD, PhD, chief of the division of pediatric infectious diseases at Children’s Hospital of Philadelphia, where clinicians have seen several cases similar to those described by NHS England and the New York City health department. “This suggests that these symptoms are ‘postinfectious,’ likely due to an abnormal immune response that happens after viral infection.”

She noted at the time of her interview, however, that fewer than 100 U.S. pediatric cases appear to have been reported.

“While our understanding is evolving, given the scope of the COVID-19 pandemic, this suggests that this kind of severe disease in children is very rare indeed,” Dr. John said. “Because this syndrome is so newly described, we have to continue to be cautious in attributing this syndrome to COVID-19, as there are many other diseases that look quite similar.”

She advised clinicians to be “wary of attributing fever/rash/shock to this syndrome, as the differential is broad, and we do not want to fail to recognize and treat true toxic shock or tick-borne disease.”

Dawn Nolt, MD, MPH, an associate professor of pediatrics in infectious diseases at Oregon Health & Science University’s Doernbecher Children’s Hospital, Portland, also underscored the need to avoid drawing conclusions too quickly.

“At this time, there is no causality established between SARS-COV-2 and these inflammatory syndromes other than a temporal association,” said Dr. Nolt, whose hospital has not yet seen any of these cases. “If there is a link, then the symptoms may be from a ‘direct hit’ of the virus on tissues, or from an overly exuberant immune response.”

None of the initial 15 New York City children died, although 5 needed mechanical ventilation and over half needed blood pressure support. The one child in London died from a large cerebrovascular infarct.

If the cases are connected to COVID-19, one explanation for the presentation may be related to the leading hypothesis “that SARS-CoV-2 may stimulate the immune system in such a way to promote vasculitis,” Dr. Nolt said in an interview.

“It is unusual that this particular constellation was not reported from the known pediatric cases out of China, where the COVID-19 pandemic originated,” Dr. Nolt said. “If there is a link between SARS-CoV-2 and these inflammatory syndromes, this may have resulted from genetic/host differences, changes in the SARS-CoV-2 virus, or other factors yet to be determined.”

The New York City bulletin recommended that clinicians immediately refer children presenting with the described symptoms to a specialist in pediatric infectious disease, rheumatology, or critical care.

“Early diagnosis and treatment of patients meeting full or partial criteria for Kawasaki disease is critical to preventing end-organ damage and other long-term complications,” the bulletin stated. It recommended aspirin and intravenous immunoglobulin for those who met Kawasaki criteria.

Dr. John said that children with the presentation appear to be responding well to intravenous immunoglobulin and/or steroids. She further emphasized that virtually all pediatric patients recover from COVID-19.

“Physicians should advise families to bring their children and teens back in for evaluation if they develop new fever, rash, or abdominal pain and diarrhea,” Dr. John said. “Families should not be afraid to seek care when their kids are sick. Our pediatric hospitals and EDs are open for business and working hard to protect staff and patients.”

A Kawasaki syndrome diagnosis requires at least 5 days of a fever at 101-104° F or higher along with four of the following five symptoms: rash over the torso; redness and swelling on palms and soles of the feet with later skin peeling; bloodshot, light-sensitive eyes; swollen lymph glands in the neck; and irritation and inflammation of the mouth, lips and throat, sometimes with “strawberry” tongue, according to the American Heart Association.

A press release from the AHA noted that Kawasaki disease is the most common cause of acquired heart disease in developed countries, but the condition remains rare.

Kawasaki disease’s etiology is unknown, but “some evidence suggests an infectious trigger, with winter-spring seasonality of the disease,” wrote the case study authors, noting that past research has linked Kawasaki disease with previous or concurrent infections of rhinovirus/enterovirus, parainfluenza, respiratory syncytial virus, influenza, adenovirus, and the four common human coronavirus strains.

“We have to remember that our experience with this pandemic is less than 12 months,” Dr. Nolt said. “We are still accumulating information, and any additional manifestations, particularly severe ones, adds to our ability to more quickly detect and treat children.”

Dr. Nolt and Dr. John had no disclosures.

SOURCES: Jones VG et al. Hosp Pediatr. 2020 Apr 7. doi: 10.1542/hpeds.2020-0123; Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.

A novel clinical presentation in children involving symptoms seen with atypical Kawasaki disease and toxic shock syndrome may be linked to COVID-19 infection, according to reports from National Health Service England, The Lancet, and the New York City health department.

Courtesy NIAID-RML

Fifteen children in New York City hospitals have presented with the condition, provisionally called pediatric multisystem inflammatory syndrome, between April 17 and May 1, according to a health alert from New York City health department deputy commissioner Demetre C. Daskalakis, MD, MPH, on May 4. On May 5, the New York state department of health released a health advisory that 64 suspected cases had been reported in children in New York state hospitals, including New York City.

The New York City reports follow a case study published April 7 in Hospital Pediatrics about the presentation. There also was a statement from the U.K.’s Paediatric Intensive Care Society (PICS) on April 27 that noted “blood parameters consistent with severe COVID-19 in children” as well as abdominal pain, gastrointestinal symptoms, and cardiac inflammation.

“Whilst it is too early to say with confidence, features appear to include high CRP [C-reactive protein], high [erythrocyte sedimentation rate] and high ferritin,” the PICS release stated. The cardiac inflammation consists of “myocarditis with raised troponin and [prohormone brain natriuretic peptide],” according to the PICS statement. “Some have an appearance of their coronary arteries in keeping with Kawasaki disease.”

The initial 15 New York City patients reportedly all had “subjective or measured fever, and more than half reported rash, abdominal pain, vomiting, or diarrhea,” but fewer than half had respiratory symptoms.

The case study described a 6-month-old infant who was admitted and diagnosed with classic Kawasaki disease, who also tested positive for COVID-19 with fever and mild respiratory symptoms, reported Veena G. Jones, MD, a pediatric hospitalist in Palo Alto, Calif., and associates.

While many of the U.K. children presenting with the symptoms had a positive polymerase chain reaction tests for infection from SARS-CoV-2, some also had a negative test. Polymerase chain reaction testing in New York City was positive for 4 children and negative for 11 children, but 6 of the those who tested negative had positive serology tests, potentially pointing to postinfection sequelae.

At press time, more cases were reported from the United Kingdom in The Lancet. In London, eight children with hyperinflammatory shock, showing features similar to atypical Kawasaki disease, Kawasaki disease shock syndrome, or toxic shock syndrome, presented within 10 days to Evelina London Children’s Hospital Paediatric ICU, Shelley Riphagen, MBChB, and colleagues revealed.

Clinically, their presentations were similar, with persistent fever, rash, conjunctivitis, peripheral edema, extremity pain, and gastrointestinal symptoms. They all developed warm vasoplegic shock that did not respond to volume resuscitation; noradrenaline and milrinone were administered for hemodynamic support. Seven of the children needed mechanical ventilation for cardiovascular stabilization, although most of them had no significant respiratory involvement.

Of note was development of small pleural, pericardial, and ascitic effusion – “suggestive of a diffuse inflammatory process,” Dr. Riphagen and associates wrote. None of the children initially was positive for SARS-CoV-2; laboratory evidence of infection or inflammation included “elevated concentrations of CRP, procalcitonin, ferritin, triglycerides or d-dimers.”

“A common echocardiographic finding was echobright coronary vessels,” they wrote. “One child developed arrhythmia with refractory shock, requiring extracorporeal life support, and died from a large cerebrovascular infarct.”

As the article went to press, the doctors in that same ICU had seen more than 20 children with similar clinical presentations, Dr. Riphagen and associates reported, and the first 10 tested positive for SARS-CoV-2 antibody, including the 8 described above.

“Most of the children appear to have antibodies to the novel coronavirus, even when they do not have virus detectable in their nose,” said Audrey John, MD, PhD, chief of the division of pediatric infectious diseases at Children’s Hospital of Philadelphia, where clinicians have seen several cases similar to those described by NHS England and the New York City health department. “This suggests that these symptoms are ‘postinfectious,’ likely due to an abnormal immune response that happens after viral infection.”

She noted at the time of her interview, however, that fewer than 100 U.S. pediatric cases appear to have been reported.

“While our understanding is evolving, given the scope of the COVID-19 pandemic, this suggests that this kind of severe disease in children is very rare indeed,” Dr. John said. “Because this syndrome is so newly described, we have to continue to be cautious in attributing this syndrome to COVID-19, as there are many other diseases that look quite similar.”

She advised clinicians to be “wary of attributing fever/rash/shock to this syndrome, as the differential is broad, and we do not want to fail to recognize and treat true toxic shock or tick-borne disease.”

Dawn Nolt, MD, MPH, an associate professor of pediatrics in infectious diseases at Oregon Health & Science University’s Doernbecher Children’s Hospital, Portland, also underscored the need to avoid drawing conclusions too quickly.

“At this time, there is no causality established between SARS-COV-2 and these inflammatory syndromes other than a temporal association,” said Dr. Nolt, whose hospital has not yet seen any of these cases. “If there is a link, then the symptoms may be from a ‘direct hit’ of the virus on tissues, or from an overly exuberant immune response.”

None of the initial 15 New York City children died, although 5 needed mechanical ventilation and over half needed blood pressure support. The one child in London died from a large cerebrovascular infarct.

If the cases are connected to COVID-19, one explanation for the presentation may be related to the leading hypothesis “that SARS-CoV-2 may stimulate the immune system in such a way to promote vasculitis,” Dr. Nolt said in an interview.

“It is unusual that this particular constellation was not reported from the known pediatric cases out of China, where the COVID-19 pandemic originated,” Dr. Nolt said. “If there is a link between SARS-CoV-2 and these inflammatory syndromes, this may have resulted from genetic/host differences, changes in the SARS-CoV-2 virus, or other factors yet to be determined.”

The New York City bulletin recommended that clinicians immediately refer children presenting with the described symptoms to a specialist in pediatric infectious disease, rheumatology, or critical care.

“Early diagnosis and treatment of patients meeting full or partial criteria for Kawasaki disease is critical to preventing end-organ damage and other long-term complications,” the bulletin stated. It recommended aspirin and intravenous immunoglobulin for those who met Kawasaki criteria.

Dr. John said that children with the presentation appear to be responding well to intravenous immunoglobulin and/or steroids. She further emphasized that virtually all pediatric patients recover from COVID-19.

“Physicians should advise families to bring their children and teens back in for evaluation if they develop new fever, rash, or abdominal pain and diarrhea,” Dr. John said. “Families should not be afraid to seek care when their kids are sick. Our pediatric hospitals and EDs are open for business and working hard to protect staff and patients.”

A Kawasaki syndrome diagnosis requires at least 5 days of a fever at 101-104° F or higher along with four of the following five symptoms: rash over the torso; redness and swelling on palms and soles of the feet with later skin peeling; bloodshot, light-sensitive eyes; swollen lymph glands in the neck; and irritation and inflammation of the mouth, lips and throat, sometimes with “strawberry” tongue, according to the American Heart Association.

A press release from the AHA noted that Kawasaki disease is the most common cause of acquired heart disease in developed countries, but the condition remains rare.

Kawasaki disease’s etiology is unknown, but “some evidence suggests an infectious trigger, with winter-spring seasonality of the disease,” wrote the case study authors, noting that past research has linked Kawasaki disease with previous or concurrent infections of rhinovirus/enterovirus, parainfluenza, respiratory syncytial virus, influenza, adenovirus, and the four common human coronavirus strains.

“We have to remember that our experience with this pandemic is less than 12 months,” Dr. Nolt said. “We are still accumulating information, and any additional manifestations, particularly severe ones, adds to our ability to more quickly detect and treat children.”

Dr. Nolt and Dr. John had no disclosures.

SOURCES: Jones VG et al. Hosp Pediatr. 2020 Apr 7. doi: 10.1542/hpeds.2020-0123; Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.

A couple of weeks ago, I posted a silly picture of myself with one N95 mask and asked the folks on Twitter what else I might need. In a matter of a few days, I had filled out a form online for volunteering through the Society of Critical Care Medicine, been assigned to work at a hospital in New York City, and booked a hotel and flight.

Courtesy Arghavan Salles, MD

I was going to volunteer, although I wasn’t sure of exactly what I would be doing. I’m trained as a bariatric surgeon – not obviously suited for critical care, but arguably even less suited for medicine wards.

I undoubtedly would have been less prepared if I hadn’t sought guidance on what to bring with me and generally what to expect. Less than a day after seeking advice, two local women physicians donated N95s, face shields, gowns, bouffants, and coveralls to me. I also received a laminated photo of myself to attach to my gown in the mail from a stranger I met online.

Others suggested I bring goggles, chocolate, protein bars, hand sanitizer, powdered laundry detergent, and alcohol wipes. After running around all over town, I was able find everything but the wipes.

Just as others helped me achieve my goal of volunteering, I hope I can guide those who would like to do similar work by sharing details about my experience and other information I have collected about volunteering.

Below I answer some questions that those considering volunteering might have, including why I went, who I contacted to set this up, who paid for my flight, and what I observed in the hospital.
 

Motivation and logistics

I am currently serving in a nonclinical role at my institution. So when the pandemic hit the United States, I felt an immense amount of guilt for not being on the front lines caring for patients. I offered my services to local hospitals and registered for the California Health Corps. I live in northern California, which was the first part of the country to shelter in place. Since my home was actually relatively spared, my services weren’t needed.

As the weeks passed, I was slowly getting more and more fit, exercising in my house since there was little else I could do, and the guilt became a cloud gathering over my head.

I decided to volunteer in a place where demands for help were higher – New York. I tried very hard to sign up to volunteer through the state’s registry for health care volunteers, but was unable to do so. Coincidentally, around that same time, I saw on Twitter that Josh Mugele, MD, emergency medicine physician and program director of the emergency medicine residency at Northeast Georgia Medical Center in Gainesville, was on his way to New York. He shared the Society of Critical Care Medicine’s form for volunteering with me, and in less than 48 hours, I was assigned to a hospital in New York City. Five days later I was on a plane from San Francisco to my destination on the opposite side of the country. The airline paid for my flight.

This is not the only path to volunteering. Another volunteer, Sara Pauk, MD, ob.gyn. at the University of Washington, Seattle, found her volunteer role through contacting the New York City Health and Hospitals system directly. Other who have volunteered told me they had contacted specific hospitals or worked with agencies that were placing physicians.
 

PPE

Courtesy Arghavan Salles. MD

The Brooklyn hospital where I volunteered provided me with two sets of scrubs and two N95s. Gowns were variably available on our unit, and there was no eye protection. As a colleague of mine, Ben Daxon, MD, anesthesia and critical care physician at the Mayo Clinic in Rochester, Minn., had suggested, anyone volunteering in this context should bring personal protective equipment (PPE) – That includes gowns, bouffants/scrub caps, eye protection, masks, and scrubs.

The “COVID corner”

Once I arrived in New York, I did not feel particularly safe in my hotel, so I moved to another the next day. Then I had to sort out how to keep the whole room from being contaminated. I created a “COVID corner” right by the door where I kept almost everything that had been outside the door.

Every time I walked in the door, I immediately took off my shoes and left them in that corner. I could not find alcohol wipes, even after looking around in the city, so I relied on time to kill the virus, which I presumed was on everything that came from outside.

Courtesy Arghavan Salles, MD

Groceries stayed by the door for 48-72 hours if possible. After that, I would move them to the “clean” parts of the room. I wore the same outfit to and from the hospital everyday, putting it on right before I left and taking it off immediately after walking into the room (and then proceeding directly to the shower). Those clothes – “my COVID outfit” – lived in the COVID corner. Anything else I wore, including exercise clothes and underwear, got washed right after I wore it.

At the hospital, I would change into scrubs and leave my COVID outfit in a plastic bag inside my handbag. Note: I fully accepted that my handbag was now a COVID handbag. I kept a pair of clogs in the hospital for daily wear. Without alcohol wipes, my room did not feel clean. But I did start to become at peace with my system, even though it was inferior to the system I use in my own home.

Meal time

In addition to bringing snacks from home, I gathered some meal items at a grocery store during my first day in New York. These included water, yogurt, a few protein drinks, fruit, and some mini chocolate croissants. It’s a pandemic – chocolate is encouraged, right?

Neither any of the volunteers I knew nor I had access to a kitchen, so this was about the best I could do.

My first week I worked nights and ate sporadically. A couple of days I bought bagel sandwiches on the way back to the hotel in the morning. Other times, I would eat yogurt or a protein bar.

I had trouble sleeping, so I would wake up early and either do yoga in my room or go for a run in a nearby park. Usually I didn’t plan well enough to eat before I went into the hospital, so I would take yogurt, some fruit, and a croissant with me as I headed out. It was hard eating on the run with a mask on my face.

When I switched to working days, I actually ordered proper dinners from local Thai, Mexican, and Indian restaurants. I paid around $20 a meal.

One night I even had dinner with a coworker who was staying at a hotel close to mine – what a luxury! Prior to all this I had been sheltering in place alone for weeks, so in that sense, this experience was a delight. I interacted with other people, in person, every day!
 

My commute

My hotel was about 20 minutes from the hospital. Well-meaning folks informed me that Hertz had free car rentals and Uber had discounts for health care workers. When I investigated these options, I found that only employees of certain hospitals were eligible. As a volunteer, I was not eligible.

Courtesy Arghavan Salles, MD

I ultimately took Uber back and forth, and I was lucky that a few friends had sent me Uber gift cards to defray the costs. Most days, I paid about $20 each way, although 1 day there actually was “surge pricing.” The grand total for the trip was close to $800.

Many of the Uber drivers had put up plastic partitions – reminiscent of the plastic Dexter would use to contain his crime scenes – to increase their separation from their passengers. It was a bit eerie, but also somewhat welcome.
 

New normal

The actual work at the hospital in Brooklyn where I volunteered was different from usual practice in numerous ways. One of the things I immediately noticed was how difficult it was to get chest x-rays. After placing an emergent chest tube for a tension pneumothorax, it took about 6 hours to get a chest x-ray to assess placement.

Because code medications were needed much more frequently than normal times, these medications were kept in an open supply closet for ease of access. Many of the ventilators looked like they were from the 1970s. (They had been borrowed from the Federal Emergency Management Agency.)

What was most distinct about this work was the sheer volume of deaths and dying patients -- at least one death on our unit occurred every day I was there -- and the way families communicated with their loved ones. Countless times I held my phone over the faces of my unconscious patients to let their family profess their love and beg them to fight. While I have had to deliver bad news over the phone many times in my career, I have never had to intrude on families’ last conversations with their dying loved ones or witness that conversation occurring via a tiny screen.
 

Reentry

In many ways, I am lucky that I do not do clinical work in my hometown. So while other volunteers were figuring out how many more vacation days they would have to use, or whether they would have to take unpaid leave, and when and how they would get tested, all I had to do was prepare to go back home and quarantine myself for a couple of weeks.

I used up 2 weeks of vacation to volunteer in New York, but luckily, I could resume my normal work the day after I returned home.

Obviously, living in the pandemic is unique to anything we have ever experienced. Recognizing that, I recorded video diaries the whole time I was in New York. I laughed (like when I tried to fit all of my PPE on my tiny head), and I cried – several times. I suppose 1 day I may actually watch them and be reminded of what it was like to have been able to serve in this historic moment. Until then, they will remain locked up on the same phone that served as the only communication vehicle between my patients and their loved ones.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University.

A couple of weeks ago, I posted a silly picture of myself with one N95 mask and asked the folks on Twitter what else I might need. In a matter of a few days, I had filled out a form online for volunteering through the Society of Critical Care Medicine, been assigned to work at a hospital in New York City, and booked a hotel and flight.

Courtesy Arghavan Salles, MD

I was going to volunteer, although I wasn’t sure of exactly what I would be doing. I’m trained as a bariatric surgeon – not obviously suited for critical care, but arguably even less suited for medicine wards.

I undoubtedly would have been less prepared if I hadn’t sought guidance on what to bring with me and generally what to expect. Less than a day after seeking advice, two local women physicians donated N95s, face shields, gowns, bouffants, and coveralls to me. I also received a laminated photo of myself to attach to my gown in the mail from a stranger I met online.

Others suggested I bring goggles, chocolate, protein bars, hand sanitizer, powdered laundry detergent, and alcohol wipes. After running around all over town, I was able find everything but the wipes.

Just as others helped me achieve my goal of volunteering, I hope I can guide those who would like to do similar work by sharing details about my experience and other information I have collected about volunteering.

Below I answer some questions that those considering volunteering might have, including why I went, who I contacted to set this up, who paid for my flight, and what I observed in the hospital.
 

Motivation and logistics

I am currently serving in a nonclinical role at my institution. So when the pandemic hit the United States, I felt an immense amount of guilt for not being on the front lines caring for patients. I offered my services to local hospitals and registered for the California Health Corps. I live in northern California, which was the first part of the country to shelter in place. Since my home was actually relatively spared, my services weren’t needed.

As the weeks passed, I was slowly getting more and more fit, exercising in my house since there was little else I could do, and the guilt became a cloud gathering over my head.

I decided to volunteer in a place where demands for help were higher – New York. I tried very hard to sign up to volunteer through the state’s registry for health care volunteers, but was unable to do so. Coincidentally, around that same time, I saw on Twitter that Josh Mugele, MD, emergency medicine physician and program director of the emergency medicine residency at Northeast Georgia Medical Center in Gainesville, was on his way to New York. He shared the Society of Critical Care Medicine’s form for volunteering with me, and in less than 48 hours, I was assigned to a hospital in New York City. Five days later I was on a plane from San Francisco to my destination on the opposite side of the country. The airline paid for my flight.

This is not the only path to volunteering. Another volunteer, Sara Pauk, MD, ob.gyn. at the University of Washington, Seattle, found her volunteer role through contacting the New York City Health and Hospitals system directly. Other who have volunteered told me they had contacted specific hospitals or worked with agencies that were placing physicians.
 

PPE

Courtesy Arghavan Salles. MD

The Brooklyn hospital where I volunteered provided me with two sets of scrubs and two N95s. Gowns were variably available on our unit, and there was no eye protection. As a colleague of mine, Ben Daxon, MD, anesthesia and critical care physician at the Mayo Clinic in Rochester, Minn., had suggested, anyone volunteering in this context should bring personal protective equipment (PPE) – That includes gowns, bouffants/scrub caps, eye protection, masks, and scrubs.

The “COVID corner”

Once I arrived in New York, I did not feel particularly safe in my hotel, so I moved to another the next day. Then I had to sort out how to keep the whole room from being contaminated. I created a “COVID corner” right by the door where I kept almost everything that had been outside the door.

Every time I walked in the door, I immediately took off my shoes and left them in that corner. I could not find alcohol wipes, even after looking around in the city, so I relied on time to kill the virus, which I presumed was on everything that came from outside.

Courtesy Arghavan Salles, MD

Groceries stayed by the door for 48-72 hours if possible. After that, I would move them to the “clean” parts of the room. I wore the same outfit to and from the hospital everyday, putting it on right before I left and taking it off immediately after walking into the room (and then proceeding directly to the shower). Those clothes – “my COVID outfit” – lived in the COVID corner. Anything else I wore, including exercise clothes and underwear, got washed right after I wore it.

At the hospital, I would change into scrubs and leave my COVID outfit in a plastic bag inside my handbag. Note: I fully accepted that my handbag was now a COVID handbag. I kept a pair of clogs in the hospital for daily wear. Without alcohol wipes, my room did not feel clean. But I did start to become at peace with my system, even though it was inferior to the system I use in my own home.

Meal time

In addition to bringing snacks from home, I gathered some meal items at a grocery store during my first day in New York. These included water, yogurt, a few protein drinks, fruit, and some mini chocolate croissants. It’s a pandemic – chocolate is encouraged, right?

Neither any of the volunteers I knew nor I had access to a kitchen, so this was about the best I could do.

My first week I worked nights and ate sporadically. A couple of days I bought bagel sandwiches on the way back to the hotel in the morning. Other times, I would eat yogurt or a protein bar.

I had trouble sleeping, so I would wake up early and either do yoga in my room or go for a run in a nearby park. Usually I didn’t plan well enough to eat before I went into the hospital, so I would take yogurt, some fruit, and a croissant with me as I headed out. It was hard eating on the run with a mask on my face.

When I switched to working days, I actually ordered proper dinners from local Thai, Mexican, and Indian restaurants. I paid around $20 a meal.

One night I even had dinner with a coworker who was staying at a hotel close to mine – what a luxury! Prior to all this I had been sheltering in place alone for weeks, so in that sense, this experience was a delight. I interacted with other people, in person, every day!
 

My commute

My hotel was about 20 minutes from the hospital. Well-meaning folks informed me that Hertz had free car rentals and Uber had discounts for health care workers. When I investigated these options, I found that only employees of certain hospitals were eligible. As a volunteer, I was not eligible.

Courtesy Arghavan Salles, MD

I ultimately took Uber back and forth, and I was lucky that a few friends had sent me Uber gift cards to defray the costs. Most days, I paid about $20 each way, although 1 day there actually was “surge pricing.” The grand total for the trip was close to $800.

Many of the Uber drivers had put up plastic partitions – reminiscent of the plastic Dexter would use to contain his crime scenes – to increase their separation from their passengers. It was a bit eerie, but also somewhat welcome.
 

New normal

The actual work at the hospital in Brooklyn where I volunteered was different from usual practice in numerous ways. One of the things I immediately noticed was how difficult it was to get chest x-rays. After placing an emergent chest tube for a tension pneumothorax, it took about 6 hours to get a chest x-ray to assess placement.

Because code medications were needed much more frequently than normal times, these medications were kept in an open supply closet for ease of access. Many of the ventilators looked like they were from the 1970s. (They had been borrowed from the Federal Emergency Management Agency.)

What was most distinct about this work was the sheer volume of deaths and dying patients -- at least one death on our unit occurred every day I was there -- and the way families communicated with their loved ones. Countless times I held my phone over the faces of my unconscious patients to let their family profess their love and beg them to fight. While I have had to deliver bad news over the phone many times in my career, I have never had to intrude on families’ last conversations with their dying loved ones or witness that conversation occurring via a tiny screen.
 

Reentry

In many ways, I am lucky that I do not do clinical work in my hometown. So while other volunteers were figuring out how many more vacation days they would have to use, or whether they would have to take unpaid leave, and when and how they would get tested, all I had to do was prepare to go back home and quarantine myself for a couple of weeks.

I used up 2 weeks of vacation to volunteer in New York, but luckily, I could resume my normal work the day after I returned home.

Obviously, living in the pandemic is unique to anything we have ever experienced. Recognizing that, I recorded video diaries the whole time I was in New York. I laughed (like when I tried to fit all of my PPE on my tiny head), and I cried – several times. I suppose 1 day I may actually watch them and be reminded of what it was like to have been able to serve in this historic moment. Until then, they will remain locked up on the same phone that served as the only communication vehicle between my patients and their loved ones.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University.

A couple of weeks ago, I posted a silly picture of myself with one N95 mask and asked the folks on Twitter what else I might need. In a matter of a few days, I had filled out a form online for volunteering through the Society of Critical Care Medicine, been assigned to work at a hospital in New York City, and booked a hotel and flight.

Courtesy Arghavan Salles, MD

I was going to volunteer, although I wasn’t sure of exactly what I would be doing. I’m trained as a bariatric surgeon – not obviously suited for critical care, but arguably even less suited for medicine wards.

I undoubtedly would have been less prepared if I hadn’t sought guidance on what to bring with me and generally what to expect. Less than a day after seeking advice, two local women physicians donated N95s, face shields, gowns, bouffants, and coveralls to me. I also received a laminated photo of myself to attach to my gown in the mail from a stranger I met online.

Others suggested I bring goggles, chocolate, protein bars, hand sanitizer, powdered laundry detergent, and alcohol wipes. After running around all over town, I was able find everything but the wipes.

Just as others helped me achieve my goal of volunteering, I hope I can guide those who would like to do similar work by sharing details about my experience and other information I have collected about volunteering.

Below I answer some questions that those considering volunteering might have, including why I went, who I contacted to set this up, who paid for my flight, and what I observed in the hospital.
 

Motivation and logistics

I am currently serving in a nonclinical role at my institution. So when the pandemic hit the United States, I felt an immense amount of guilt for not being on the front lines caring for patients. I offered my services to local hospitals and registered for the California Health Corps. I live in northern California, which was the first part of the country to shelter in place. Since my home was actually relatively spared, my services weren’t needed.

As the weeks passed, I was slowly getting more and more fit, exercising in my house since there was little else I could do, and the guilt became a cloud gathering over my head.

I decided to volunteer in a place where demands for help were higher – New York. I tried very hard to sign up to volunteer through the state’s registry for health care volunteers, but was unable to do so. Coincidentally, around that same time, I saw on Twitter that Josh Mugele, MD, emergency medicine physician and program director of the emergency medicine residency at Northeast Georgia Medical Center in Gainesville, was on his way to New York. He shared the Society of Critical Care Medicine’s form for volunteering with me, and in less than 48 hours, I was assigned to a hospital in New York City. Five days later I was on a plane from San Francisco to my destination on the opposite side of the country. The airline paid for my flight.

This is not the only path to volunteering. Another volunteer, Sara Pauk, MD, ob.gyn. at the University of Washington, Seattle, found her volunteer role through contacting the New York City Health and Hospitals system directly. Other who have volunteered told me they had contacted specific hospitals or worked with agencies that were placing physicians.
 

PPE

Courtesy Arghavan Salles. MD

The Brooklyn hospital where I volunteered provided me with two sets of scrubs and two N95s. Gowns were variably available on our unit, and there was no eye protection. As a colleague of mine, Ben Daxon, MD, anesthesia and critical care physician at the Mayo Clinic in Rochester, Minn., had suggested, anyone volunteering in this context should bring personal protective equipment (PPE) – That includes gowns, bouffants/scrub caps, eye protection, masks, and scrubs.

The “COVID corner”

Once I arrived in New York, I did not feel particularly safe in my hotel, so I moved to another the next day. Then I had to sort out how to keep the whole room from being contaminated. I created a “COVID corner” right by the door where I kept almost everything that had been outside the door.

Every time I walked in the door, I immediately took off my shoes and left them in that corner. I could not find alcohol wipes, even after looking around in the city, so I relied on time to kill the virus, which I presumed was on everything that came from outside.

Courtesy Arghavan Salles, MD

Groceries stayed by the door for 48-72 hours if possible. After that, I would move them to the “clean” parts of the room. I wore the same outfit to and from the hospital everyday, putting it on right before I left and taking it off immediately after walking into the room (and then proceeding directly to the shower). Those clothes – “my COVID outfit” – lived in the COVID corner. Anything else I wore, including exercise clothes and underwear, got washed right after I wore it.

At the hospital, I would change into scrubs and leave my COVID outfit in a plastic bag inside my handbag. Note: I fully accepted that my handbag was now a COVID handbag. I kept a pair of clogs in the hospital for daily wear. Without alcohol wipes, my room did not feel clean. But I did start to become at peace with my system, even though it was inferior to the system I use in my own home.

Meal time

In addition to bringing snacks from home, I gathered some meal items at a grocery store during my first day in New York. These included water, yogurt, a few protein drinks, fruit, and some mini chocolate croissants. It’s a pandemic – chocolate is encouraged, right?

Neither any of the volunteers I knew nor I had access to a kitchen, so this was about the best I could do.

My first week I worked nights and ate sporadically. A couple of days I bought bagel sandwiches on the way back to the hotel in the morning. Other times, I would eat yogurt or a protein bar.

I had trouble sleeping, so I would wake up early and either do yoga in my room or go for a run in a nearby park. Usually I didn’t plan well enough to eat before I went into the hospital, so I would take yogurt, some fruit, and a croissant with me as I headed out. It was hard eating on the run with a mask on my face.

When I switched to working days, I actually ordered proper dinners from local Thai, Mexican, and Indian restaurants. I paid around $20 a meal.

One night I even had dinner with a coworker who was staying at a hotel close to mine – what a luxury! Prior to all this I had been sheltering in place alone for weeks, so in that sense, this experience was a delight. I interacted with other people, in person, every day!
 

My commute

My hotel was about 20 minutes from the hospital. Well-meaning folks informed me that Hertz had free car rentals and Uber had discounts for health care workers. When I investigated these options, I found that only employees of certain hospitals were eligible. As a volunteer, I was not eligible.

Courtesy Arghavan Salles, MD

I ultimately took Uber back and forth, and I was lucky that a few friends had sent me Uber gift cards to defray the costs. Most days, I paid about $20 each way, although 1 day there actually was “surge pricing.” The grand total for the trip was close to $800.

Many of the Uber drivers had put up plastic partitions – reminiscent of the plastic Dexter would use to contain his crime scenes – to increase their separation from their passengers. It was a bit eerie, but also somewhat welcome.
 

New normal

The actual work at the hospital in Brooklyn where I volunteered was different from usual practice in numerous ways. One of the things I immediately noticed was how difficult it was to get chest x-rays. After placing an emergent chest tube for a tension pneumothorax, it took about 6 hours to get a chest x-ray to assess placement.

Because code medications were needed much more frequently than normal times, these medications were kept in an open supply closet for ease of access. Many of the ventilators looked like they were from the 1970s. (They had been borrowed from the Federal Emergency Management Agency.)

What was most distinct about this work was the sheer volume of deaths and dying patients -- at least one death on our unit occurred every day I was there -- and the way families communicated with their loved ones. Countless times I held my phone over the faces of my unconscious patients to let their family profess their love and beg them to fight. While I have had to deliver bad news over the phone many times in my career, I have never had to intrude on families’ last conversations with their dying loved ones or witness that conversation occurring via a tiny screen.
 

Reentry

In many ways, I am lucky that I do not do clinical work in my hometown. So while other volunteers were figuring out how many more vacation days they would have to use, or whether they would have to take unpaid leave, and when and how they would get tested, all I had to do was prepare to go back home and quarantine myself for a couple of weeks.

I used up 2 weeks of vacation to volunteer in New York, but luckily, I could resume my normal work the day after I returned home.

Obviously, living in the pandemic is unique to anything we have ever experienced. Recognizing that, I recorded video diaries the whole time I was in New York. I laughed (like when I tried to fit all of my PPE on my tiny head), and I cried – several times. I suppose 1 day I may actually watch them and be reminded of what it was like to have been able to serve in this historic moment. Until then, they will remain locked up on the same phone that served as the only communication vehicle between my patients and their loved ones.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University.

As the COVID-19 pandemic has swept across the world, a striking difference has been seen between the sexes. But why are men so much more susceptible to severe outcomes from COVID-19 than women?

Suspicions naturally turn to the sex hormones, and there have been suggestions that estrogen may be protective against COVID-19 in females and/or that androgens worsen COVID-19 outcomes in males.

New data supporting the androgen theory come from a study in Italy.

These researchers found that patients with prostate cancer being treated with androgen deprivation therapy (ADT) were less likely to become infected with COVID-19 and die from the disease than other groups, including other patients with cancer.

The findings suggest that androgens somehow make the virus more virulent and that this exacerbates the severity of disease in men, they say. They also speculate that ADT may be protective against COVID-19.

The study was published online May 7 in Annals of Oncology.

The team analyzed data from 68 hospitals in the Veneto region, one of the areas in Italy most severely affected by the COVID-19 pandemic.

They found data on 9280 patients with laboratory-confirmed SARS-CoV-2 infection — of whom 4532 were males.

Women in the region were actually slightly more likely to be infected with COVID-19 than men, 56% vs 44%, the researchers point out.

However, men were more prone to develop more severe forms of the disease: 60% of men vs 40% of women required hospitalization, rising to 78% of men vs 22% of women who required intensive care. Also, more men died than women (62% vs 38%).

The team then turned their focus onto patients with cancer.

Of the entire male population of Veneto, those with cancer had an almost twofold higher risk of becoming infected with COVID-19 than men without cancer (P < .0001).

However, when the team looked specifically at men with prostate cancer in the region, they found “strikingly, only 4 out of 5273 patients receiving ADT developed SARS-CoV-2 infection and none of these patients died.”

This compared to 37,161 men with prostate cancer who were not receiving ADT, among whom 114 men developed COVID-19 and 18 died.

Among another 79,661 patients in the Veneto region with cancer other than prostate cancer, 312 developed COVID-19 and 57 died.

“This is the first paper to suggest a link between ADT and COVID-19,” commented lead author Andrea Alimonti, MD, PhD, Università della Svizzera Italiana in Lugano, Switzerland.

“Patients with prostate cancer receiving ADT had a significant fourfold reduced risk of COVID-19 infections compared to patients who did not receive ADT. An even greater difference (fivefold reduction in risk) was found when we compared prostate cancer patients receiving ADT to patients with any other type of cancer,” he said.

The finding raises “the hypothesis that androgen levels can facilitate coronavirus infections and increase the severity of symptoms, as has been seen in male patients,” he said.

“These data are very interesting and raise a fascinating hypothesis,” said Richard Martin, PhD, professor of clinical epidemiology at the University of Bristol, UK, commenting about the study. “But they do need independent validation in other large population-wide datasets...with appropriate statistical analysis including adjustment for important risk factors for SARS-CoV-2.”

He noted that the Italian study results were not adjusted for potential confounders, for example, age, body mass index, and cardiometabolic comorbidities, that are strong risk factors for SARS-CoV-2. In addition, men taking ADT may have been more likely to self-isolate and so be at reduced risk of getting the infection, he suggested.
 

How Do Androgens Interact With the Virus?

Alimonti and colleagues offer a mechanistic explanation of how androgens interact with the virus.

Coronavirus gains entry into the human cell by binding its viral spike (S) proteins to ACE2 and on S protein priming by TMPRSS2. TMPRSS2 is a member of a family of proteins called type II transmembrane serine proteases, which are involved in a number of processes including cancer and viral infections, they explain.

“Intriguingly, TMPRSS2 is an androgen-regulated gene that is upregulated in prostate cancer where it supports tumor progression,” they point out.

There is also evidence that the same androgen receptor regulates TMPRSS2 expression in nonprostatic tissues, including the lungs.

“[This] may explain the increased susceptibility of men to develop SARS-CoV-2 severe infections when compared to women,” the authors speculate.

Because ADT is known to decrease TMPRSS2 levels, they suggest that androgen receptor antagonists “could be used to block or decrease the severity of SARS-CoV-2 infection in male patients.”

They go even further and suggest that men without prostate cancer at high risk for COVID-19 could take ADT to prevent infection.

For men who do become infected with COVID-19, ADT might also help reduce symptom severity, they add.

Given that the effects of androgen receptor antagonists are reversible, “they could be used transiently (eg, 1 month) in patients affected by SARS-CoV-2, thereby reducing the risk of side effects due to long-term administration,” the authors suggest.
 

Another Theory: Is Estrogen Protective?

Another theory to explain the male/female difference for severe COVID-19 is that the female hormone estrogen may be protective.

“People have to stop putting estrogen in that ‘female hormone box’ because it’s a molecule that we all use as humans, it’s just not women,” Sharon Nachman, MD, told Medscape Medical News.

“Looking at estrogen as having potentially important immune effects is part of thinking outside the box,” she said.

Nachman is associate dean for research at the Renaissance School of Medicine, Stony Brook University in New York, and is working together with Antonios Gasparis, MD, professor of surgery at the same center.

They are exploring the use of a transdermal estrogen patch in patients with COVID-19 in a randomized trial with a placebo-controlled arm. They are recruiting patients who present to their emergency department with signs and symptoms of COVID-19, and enroll them into the trial if they are interested.

“We are testing everyone as well, but we are starting patients on the medication at the time of entry as opposed to waiting until we have a test result back,” Nachman explained.

The primary objective of the study is to evaluate whether the transdermal patch, applied to the skin for 7 days, might reduce the need for intubation in men and women infected with COVID-19 versus standard of care.

The product is the same single-use transdermal estradiol patch (Climara, 25 cm², Bayer) prescribed for postmenopausal women and will be used at the same dose, which is known to be safe.

After the patch is removed, patients will be carefully tracked for symptoms over the next 45 days to see if the patch reduced symptom severity, and if so, in which patients.

Nachman would have preferred to enroll patients before they had overt symptoms, but this simply isn’t possible in a medical center where symptomatic patients present, she told Medscape Medical News.

However, she does know that even at their own medical center, the odds are stacked against male COVID-19 patients — and something is needed to mitigate its severity in this patient group.

As they were developing the protocol for the current study, the team decided to see who was in their ICU during a single study day.

The answer: mostly males. Intubation and death rates in men in their ICU for that single day was approximately 80% compared with only 20% among women.

“We have a new horrific pathogen that is pandemic and we’re all probably going to get it, it’s just a question of when and how sick we’ll be from it,” Nachman said.

Alimonti and coauthors have reported no relevant financial relationships, as did Goulder and Nachman.

This article first appeared on Medscape.com.

As the COVID-19 pandemic has swept across the world, a striking difference has been seen between the sexes. But why are men so much more susceptible to severe outcomes from COVID-19 than women?

Suspicions naturally turn to the sex hormones, and there have been suggestions that estrogen may be protective against COVID-19 in females and/or that androgens worsen COVID-19 outcomes in males.

New data supporting the androgen theory come from a study in Italy.

These researchers found that patients with prostate cancer being treated with androgen deprivation therapy (ADT) were less likely to become infected with COVID-19 and die from the disease than other groups, including other patients with cancer.

The findings suggest that androgens somehow make the virus more virulent and that this exacerbates the severity of disease in men, they say. They also speculate that ADT may be protective against COVID-19.

The study was published online May 7 in Annals of Oncology.

The team analyzed data from 68 hospitals in the Veneto region, one of the areas in Italy most severely affected by the COVID-19 pandemic.

They found data on 9280 patients with laboratory-confirmed SARS-CoV-2 infection — of whom 4532 were males.

Women in the region were actually slightly more likely to be infected with COVID-19 than men, 56% vs 44%, the researchers point out.

However, men were more prone to develop more severe forms of the disease: 60% of men vs 40% of women required hospitalization, rising to 78% of men vs 22% of women who required intensive care. Also, more men died than women (62% vs 38%).

The team then turned their focus onto patients with cancer.

Of the entire male population of Veneto, those with cancer had an almost twofold higher risk of becoming infected with COVID-19 than men without cancer (P < .0001).

However, when the team looked specifically at men with prostate cancer in the region, they found “strikingly, only 4 out of 5273 patients receiving ADT developed SARS-CoV-2 infection and none of these patients died.”

This compared to 37,161 men with prostate cancer who were not receiving ADT, among whom 114 men developed COVID-19 and 18 died.

Among another 79,661 patients in the Veneto region with cancer other than prostate cancer, 312 developed COVID-19 and 57 died.

“This is the first paper to suggest a link between ADT and COVID-19,” commented lead author Andrea Alimonti, MD, PhD, Università della Svizzera Italiana in Lugano, Switzerland.

“Patients with prostate cancer receiving ADT had a significant fourfold reduced risk of COVID-19 infections compared to patients who did not receive ADT. An even greater difference (fivefold reduction in risk) was found when we compared prostate cancer patients receiving ADT to patients with any other type of cancer,” he said.

The finding raises “the hypothesis that androgen levels can facilitate coronavirus infections and increase the severity of symptoms, as has been seen in male patients,” he said.

“These data are very interesting and raise a fascinating hypothesis,” said Richard Martin, PhD, professor of clinical epidemiology at the University of Bristol, UK, commenting about the study. “But they do need independent validation in other large population-wide datasets...with appropriate statistical analysis including adjustment for important risk factors for SARS-CoV-2.”

He noted that the Italian study results were not adjusted for potential confounders, for example, age, body mass index, and cardiometabolic comorbidities, that are strong risk factors for SARS-CoV-2. In addition, men taking ADT may have been more likely to self-isolate and so be at reduced risk of getting the infection, he suggested.
 

How Do Androgens Interact With the Virus?

Alimonti and colleagues offer a mechanistic explanation of how androgens interact with the virus.

Coronavirus gains entry into the human cell by binding its viral spike (S) proteins to ACE2 and on S protein priming by TMPRSS2. TMPRSS2 is a member of a family of proteins called type II transmembrane serine proteases, which are involved in a number of processes including cancer and viral infections, they explain.

“Intriguingly, TMPRSS2 is an androgen-regulated gene that is upregulated in prostate cancer where it supports tumor progression,” they point out.

There is also evidence that the same androgen receptor regulates TMPRSS2 expression in nonprostatic tissues, including the lungs.

“[This] may explain the increased susceptibility of men to develop SARS-CoV-2 severe infections when compared to women,” the authors speculate.

Because ADT is known to decrease TMPRSS2 levels, they suggest that androgen receptor antagonists “could be used to block or decrease the severity of SARS-CoV-2 infection in male patients.”

They go even further and suggest that men without prostate cancer at high risk for COVID-19 could take ADT to prevent infection.

For men who do become infected with COVID-19, ADT might also help reduce symptom severity, they add.

Given that the effects of androgen receptor antagonists are reversible, “they could be used transiently (eg, 1 month) in patients affected by SARS-CoV-2, thereby reducing the risk of side effects due to long-term administration,” the authors suggest.
 

Another Theory: Is Estrogen Protective?

Another theory to explain the male/female difference for severe COVID-19 is that the female hormone estrogen may be protective.

“People have to stop putting estrogen in that ‘female hormone box’ because it’s a molecule that we all use as humans, it’s just not women,” Sharon Nachman, MD, told Medscape Medical News.

“Looking at estrogen as having potentially important immune effects is part of thinking outside the box,” she said.

Nachman is associate dean for research at the Renaissance School of Medicine, Stony Brook University in New York, and is working together with Antonios Gasparis, MD, professor of surgery at the same center.

They are exploring the use of a transdermal estrogen patch in patients with COVID-19 in a randomized trial with a placebo-controlled arm. They are recruiting patients who present to their emergency department with signs and symptoms of COVID-19, and enroll them into the trial if they are interested.

“We are testing everyone as well, but we are starting patients on the medication at the time of entry as opposed to waiting until we have a test result back,” Nachman explained.

The primary objective of the study is to evaluate whether the transdermal patch, applied to the skin for 7 days, might reduce the need for intubation in men and women infected with COVID-19 versus standard of care.

The product is the same single-use transdermal estradiol patch (Climara, 25 cm², Bayer) prescribed for postmenopausal women and will be used at the same dose, which is known to be safe.

After the patch is removed, patients will be carefully tracked for symptoms over the next 45 days to see if the patch reduced symptom severity, and if so, in which patients.

Nachman would have preferred to enroll patients before they had overt symptoms, but this simply isn’t possible in a medical center where symptomatic patients present, she told Medscape Medical News.

However, she does know that even at their own medical center, the odds are stacked against male COVID-19 patients — and something is needed to mitigate its severity in this patient group.

As they were developing the protocol for the current study, the team decided to see who was in their ICU during a single study day.

The answer: mostly males. Intubation and death rates in men in their ICU for that single day was approximately 80% compared with only 20% among women.

“We have a new horrific pathogen that is pandemic and we’re all probably going to get it, it’s just a question of when and how sick we’ll be from it,” Nachman said.

Alimonti and coauthors have reported no relevant financial relationships, as did Goulder and Nachman.

This article first appeared on Medscape.com.

As the COVID-19 pandemic has swept across the world, a striking difference has been seen between the sexes. But why are men so much more susceptible to severe outcomes from COVID-19 than women?

Suspicions naturally turn to the sex hormones, and there have been suggestions that estrogen may be protective against COVID-19 in females and/or that androgens worsen COVID-19 outcomes in males.

New data supporting the androgen theory come from a study in Italy.

These researchers found that patients with prostate cancer being treated with androgen deprivation therapy (ADT) were less likely to become infected with COVID-19 and die from the disease than other groups, including other patients with cancer.

The findings suggest that androgens somehow make the virus more virulent and that this exacerbates the severity of disease in men, they say. They also speculate that ADT may be protective against COVID-19.

The study was published online May 7 in Annals of Oncology.

The team analyzed data from 68 hospitals in the Veneto region, one of the areas in Italy most severely affected by the COVID-19 pandemic.

They found data on 9280 patients with laboratory-confirmed SARS-CoV-2 infection — of whom 4532 were males.

Women in the region were actually slightly more likely to be infected with COVID-19 than men, 56% vs 44%, the researchers point out.

However, men were more prone to develop more severe forms of the disease: 60% of men vs 40% of women required hospitalization, rising to 78% of men vs 22% of women who required intensive care. Also, more men died than women (62% vs 38%).

The team then turned their focus onto patients with cancer.

Of the entire male population of Veneto, those with cancer had an almost twofold higher risk of becoming infected with COVID-19 than men without cancer (P < .0001).

However, when the team looked specifically at men with prostate cancer in the region, they found “strikingly, only 4 out of 5273 patients receiving ADT developed SARS-CoV-2 infection and none of these patients died.”

This compared to 37,161 men with prostate cancer who were not receiving ADT, among whom 114 men developed COVID-19 and 18 died.

Among another 79,661 patients in the Veneto region with cancer other than prostate cancer, 312 developed COVID-19 and 57 died.

“This is the first paper to suggest a link between ADT and COVID-19,” commented lead author Andrea Alimonti, MD, PhD, Università della Svizzera Italiana in Lugano, Switzerland.

“Patients with prostate cancer receiving ADT had a significant fourfold reduced risk of COVID-19 infections compared to patients who did not receive ADT. An even greater difference (fivefold reduction in risk) was found when we compared prostate cancer patients receiving ADT to patients with any other type of cancer,” he said.

The finding raises “the hypothesis that androgen levels can facilitate coronavirus infections and increase the severity of symptoms, as has been seen in male patients,” he said.

“These data are very interesting and raise a fascinating hypothesis,” said Richard Martin, PhD, professor of clinical epidemiology at the University of Bristol, UK, commenting about the study. “But they do need independent validation in other large population-wide datasets...with appropriate statistical analysis including adjustment for important risk factors for SARS-CoV-2.”

He noted that the Italian study results were not adjusted for potential confounders, for example, age, body mass index, and cardiometabolic comorbidities, that are strong risk factors for SARS-CoV-2. In addition, men taking ADT may have been more likely to self-isolate and so be at reduced risk of getting the infection, he suggested.
 

How Do Androgens Interact With the Virus?

Alimonti and colleagues offer a mechanistic explanation of how androgens interact with the virus.

Coronavirus gains entry into the human cell by binding its viral spike (S) proteins to ACE2 and on S protein priming by TMPRSS2. TMPRSS2 is a member of a family of proteins called type II transmembrane serine proteases, which are involved in a number of processes including cancer and viral infections, they explain.

“Intriguingly, TMPRSS2 is an androgen-regulated gene that is upregulated in prostate cancer where it supports tumor progression,” they point out.

There is also evidence that the same androgen receptor regulates TMPRSS2 expression in nonprostatic tissues, including the lungs.

“[This] may explain the increased susceptibility of men to develop SARS-CoV-2 severe infections when compared to women,” the authors speculate.

Because ADT is known to decrease TMPRSS2 levels, they suggest that androgen receptor antagonists “could be used to block or decrease the severity of SARS-CoV-2 infection in male patients.”

They go even further and suggest that men without prostate cancer at high risk for COVID-19 could take ADT to prevent infection.

For men who do become infected with COVID-19, ADT might also help reduce symptom severity, they add.

Given that the effects of androgen receptor antagonists are reversible, “they could be used transiently (eg, 1 month) in patients affected by SARS-CoV-2, thereby reducing the risk of side effects due to long-term administration,” the authors suggest.
 

Another Theory: Is Estrogen Protective?

Another theory to explain the male/female difference for severe COVID-19 is that the female hormone estrogen may be protective.

“People have to stop putting estrogen in that ‘female hormone box’ because it’s a molecule that we all use as humans, it’s just not women,” Sharon Nachman, MD, told Medscape Medical News.

“Looking at estrogen as having potentially important immune effects is part of thinking outside the box,” she said.

Nachman is associate dean for research at the Renaissance School of Medicine, Stony Brook University in New York, and is working together with Antonios Gasparis, MD, professor of surgery at the same center.

They are exploring the use of a transdermal estrogen patch in patients with COVID-19 in a randomized trial with a placebo-controlled arm. They are recruiting patients who present to their emergency department with signs and symptoms of COVID-19, and enroll them into the trial if they are interested.

“We are testing everyone as well, but we are starting patients on the medication at the time of entry as opposed to waiting until we have a test result back,” Nachman explained.

The primary objective of the study is to evaluate whether the transdermal patch, applied to the skin for 7 days, might reduce the need for intubation in men and women infected with COVID-19 versus standard of care.

The product is the same single-use transdermal estradiol patch (Climara, 25 cm², Bayer) prescribed for postmenopausal women and will be used at the same dose, which is known to be safe.

After the patch is removed, patients will be carefully tracked for symptoms over the next 45 days to see if the patch reduced symptom severity, and if so, in which patients.

Nachman would have preferred to enroll patients before they had overt symptoms, but this simply isn’t possible in a medical center where symptomatic patients present, she told Medscape Medical News.

However, she does know that even at their own medical center, the odds are stacked against male COVID-19 patients — and something is needed to mitigate its severity in this patient group.

As they were developing the protocol for the current study, the team decided to see who was in their ICU during a single study day.

The answer: mostly males. Intubation and death rates in men in their ICU for that single day was approximately 80% compared with only 20% among women.

“We have a new horrific pathogen that is pandemic and we’re all probably going to get it, it’s just a question of when and how sick we’ll be from it,” Nachman said.

Alimonti and coauthors have reported no relevant financial relationships, as did Goulder and Nachman.

This article first appeared on Medscape.com.

Many ICUs are very busy dealing with the pandemic these days, and a recent survey shows that clinicians in the ICU are feeling the stress.

They are worried about getting infected, and they are even more worried about infecting family members, according to the Society for Critical Care Medicine, which surveyed members of four professional organizations – the American Association of Critical-Care Nurses, American College of Chest Physicians, American Thoracic Society, and the SCCM – April 7-22, 2020.

Four items in the survey assessed respondents’ level of stress or concern on a scale of 1-10:

• Personal stress before the COVID-19 pandemic.
• Personal stress as a result of COVID-19 pandemic.
• Concern about personally being exposed to COVID-19.
• Concern about exposing family members to COVID-19.

Personal stress rose from a median of 3 before the pandemic to a current 8, a level that was equaled by personal concerns about being exposed and surpassed (10) by concerns about exposing family members, the SCCM reported in a blog post.

Most of the respondents “are taking special measures to limit the potential spread of the virus to their loved ones, including implementing a decontamination routine before interacting with families,” the SCCM wrote.

The most common strategy, employed by 72% of ICU clinicians, is changing clothes before/after work. Showering before joining family was mentioned by 64% of providers, followed by limiting contact until decontamination (57%) and using hand sanitizer before entering home (51%), the SCCM said.

More extreme measures included self-isolating within their homes (16%) and staying in alternative housing away from their families (12%), the SCCM said, based on data for 9,120 clinicians in the United States.

Most of the respondents (88%) reported having cared for a patient with confirmed or presumed COVID-19. Nurses made up the majority (91%) of the sample, which also included nurse practitioners and physician assistants (4.5%) and physicians (2.9%), as well as smaller numbers of respiratory therapists, pharmacists, and emergency medicine flight personnel.

The results of the survey “underline the personal sacrifices of critical care clinicians during the COVID-19 response and suggest the need to help them proactively manage stress,” the SCCM wrote.