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COVID-19 vaccine standards questioned at FDA advisory meeting
The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).
Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.
FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
‘Time for a reset’
Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.
President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.
“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”
Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.
Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.
“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.
In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
Risks of a ‘rushed vaccine’
Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.
In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.
“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.
“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.
This article first appeared on Medscape.com.
The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).
Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.
FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
‘Time for a reset’
Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.
President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.
“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”
Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.
Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.
“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.
In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
Risks of a ‘rushed vaccine’
Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.
In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.
“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.
“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.
This article first appeared on Medscape.com.
The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).
Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.
FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
‘Time for a reset’
Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.
President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.
“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”
Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.
Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.
“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.
In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
Risks of a ‘rushed vaccine’
Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.
In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.
“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.
“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.
This article first appeared on Medscape.com.
Data on potential risks of COVID-19 in psoriasis patients limited, but reassuring
The available according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.
For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.
The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.
Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.
Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”
Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.
The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”
This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.
The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.
Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.
In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.
For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.
Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.
Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.
“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.
Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.
This publication and Global Academy for Medical Education are owned by the same parent company.
The available according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.
For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.
The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.
Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.
Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”
Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.
The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”
This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.
The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.
Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.
In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.
For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.
Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.
Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.
“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.
Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.
This publication and Global Academy for Medical Education are owned by the same parent company.
The available according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.
For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.
The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.
Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.
Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”
Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.
The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”
This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.
The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.
Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.
In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.
For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.
Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.
Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.
“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.
Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
CDC expands definition of COVID-19 exposure from ‘close contact’
New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.
“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.
Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.
In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
Beware of brief encounters?
On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.
The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.
On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.
Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.
During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
No interaction is 100% safe
“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.
“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.
“I know these are numbers, but these are also people,” Dr. Butler added.
“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”
Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.
Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
A note of optimism
Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”
“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.
“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.
New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.
“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.
Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.
In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
Beware of brief encounters?
On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.
The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.
On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.
Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.
During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
No interaction is 100% safe
“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.
“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.
“I know these are numbers, but these are also people,” Dr. Butler added.
“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”
Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.
Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
A note of optimism
Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”
“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.
“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.
New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.
“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.
Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.
In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
Beware of brief encounters?
On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.
The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.
On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.
Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.
During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
No interaction is 100% safe
“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.
“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.
“I know these are numbers, but these are also people,” Dr. Butler added.
“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”
Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.
Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
A note of optimism
Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”
“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.
“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.
FDA approves remdesivir, first treatment for COVID-19
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
Rinse and repeat? Mouthwash might mitigate COVID-19 spread
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Cardiogenic shock rate soars in COVID-positive ACS
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
FROM TCT 2020
Bronchoscopy can be conducted safely patients with severe COVID-19
Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.
Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.
“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”
Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”
For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.
Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.
The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.
The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.
The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.
About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.
“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”
Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.
“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”
The authors reported having no financial disclosures.
SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.
Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.
Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.
“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”
Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”
For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.
Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.
The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.
The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.
The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.
About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.
“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”
Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.
“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”
The authors reported having no financial disclosures.
SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.
Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.
Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.
“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”
Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”
For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.
Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.
The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.
The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.
The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.
About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.
“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”
Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.
“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”
The authors reported having no financial disclosures.
SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.
FROM CHEST
Brazil confirms death of volunteer in COVID-19 vaccine trial
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
Survey: Acceptance of COVID-19 vaccine dips below 50%
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Latest week brings 44,000 more children with COVID-19
in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of COVID-19 cases among children was 741,891 as of Oct. 15, which puts the cumulative proportion at 10.9% of the 6.8 million cases reported in all ages by 49 states (New York does not report ages), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.
The 44,258 new cases in children represented 13.3% of all cases reported during the week ending Oct. 15, down from 14.6% the previous week (children make up almost 23% of the total U.S. population), the AAP/CHA data show.
Those data also indicate that there have been almost 986 cases of COVID-19 per 100,000 children in the United States. Corresponding rates among the states range from 181 per 100,000 in Vermont to 2,581 per 100,000 in North Dakota. Tennessee (2,277) and South Carolina (2,212) are the only other states above 2,000, according to the report.
California has reported the most child cases, 89,843 (1,010 per 100,000 children), so far, followed by Florida (44,199), Illinois (42,132), and Tennessee (40,137). Seven other states have had over 20,000 cases each, the AAP and CHA noted.
Measures of severe illness continue to be low, although the data are less comprehensive. Children represent only 1.7% of all COVID-19 hospitalizations (24 states and N.Y.C. reporting) and 0.07% of all deaths (42 states and N.Y.C. reporting). Thirteen states and D.C. have had no deaths yet, while Texas has reported three times as many (27) as any other state (Arizona is next with 9, although N.Y.C. has had 15), the AAP/CHA report said.
in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of COVID-19 cases among children was 741,891 as of Oct. 15, which puts the cumulative proportion at 10.9% of the 6.8 million cases reported in all ages by 49 states (New York does not report ages), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.
The 44,258 new cases in children represented 13.3% of all cases reported during the week ending Oct. 15, down from 14.6% the previous week (children make up almost 23% of the total U.S. population), the AAP/CHA data show.
Those data also indicate that there have been almost 986 cases of COVID-19 per 100,000 children in the United States. Corresponding rates among the states range from 181 per 100,000 in Vermont to 2,581 per 100,000 in North Dakota. Tennessee (2,277) and South Carolina (2,212) are the only other states above 2,000, according to the report.
California has reported the most child cases, 89,843 (1,010 per 100,000 children), so far, followed by Florida (44,199), Illinois (42,132), and Tennessee (40,137). Seven other states have had over 20,000 cases each, the AAP and CHA noted.
Measures of severe illness continue to be low, although the data are less comprehensive. Children represent only 1.7% of all COVID-19 hospitalizations (24 states and N.Y.C. reporting) and 0.07% of all deaths (42 states and N.Y.C. reporting). Thirteen states and D.C. have had no deaths yet, while Texas has reported three times as many (27) as any other state (Arizona is next with 9, although N.Y.C. has had 15), the AAP/CHA report said.
in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of COVID-19 cases among children was 741,891 as of Oct. 15, which puts the cumulative proportion at 10.9% of the 6.8 million cases reported in all ages by 49 states (New York does not report ages), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.
The 44,258 new cases in children represented 13.3% of all cases reported during the week ending Oct. 15, down from 14.6% the previous week (children make up almost 23% of the total U.S. population), the AAP/CHA data show.
Those data also indicate that there have been almost 986 cases of COVID-19 per 100,000 children in the United States. Corresponding rates among the states range from 181 per 100,000 in Vermont to 2,581 per 100,000 in North Dakota. Tennessee (2,277) and South Carolina (2,212) are the only other states above 2,000, according to the report.
California has reported the most child cases, 89,843 (1,010 per 100,000 children), so far, followed by Florida (44,199), Illinois (42,132), and Tennessee (40,137). Seven other states have had over 20,000 cases each, the AAP and CHA noted.
Measures of severe illness continue to be low, although the data are less comprehensive. Children represent only 1.7% of all COVID-19 hospitalizations (24 states and N.Y.C. reporting) and 0.07% of all deaths (42 states and N.Y.C. reporting). Thirteen states and D.C. have had no deaths yet, while Texas has reported three times as many (27) as any other state (Arizona is next with 9, although N.Y.C. has had 15), the AAP/CHA report said.