Δευτέρα 7 Δεκεμβρίου 2020

COVID NEWS-MASK USE DEBATE GOES ON

 


Scientists involved in oversight of the Operation Warp Speed COVID-19 vaccine trials are tempering excitement about efficacy, noting that the studies haven't shown yet whether the products can prevent transmission of the SARS-CoV-2 virus.

"We don't know if people can become infected and thus also transmit even with vaccination," said former US Food and Drug Administration Commissioner Margaret Hamburg, MD, in a November 18 briefing on COVID-19 vaccines sponsored by the American Public Health Association (APHA) and the National Academy of Medicine (NAM).

For that reason and others — including if there isn't significant uptake of vaccine — "people can expect to still be wearing masks, still be asked to follow non-pharmaceutical public health measures that we've all come to know so well," she said. 

It may take a year or more to get the studies to answer the transmission question, said Larry Corey, MD, who helps oversee the vaccine trials as part of the National Institutes of Health's (NIH's) COVID-19 Prevention Network. With vaccination could come what researchers call "behavioral disinhibition" — they may start eating in restaurants, going to theaters, and sporting events without masks, he said.

That's not a good idea, said Corey, who is also president and director emeritus of the Fred Hutchinson Cancer Research Center in Seattle, Washington. Those who have been vaccinated could still continue to asymptomatically and unknowingly shed virus and spread disease. "I want people to start being aware of that," he said.

"An Important Question"

The data from the Pfizer/BioNTech and Moderna vaccines that have been reviewed by Warp Speed and NIH officials "are about protection from symptomatic disease," said Hilary Marston, MD, MPH, who coordinates the National Institute of Allergy and Infectious Diseases' response to outbreaks, including COVID-19.

Marston, who spoke to reporters separately in a meeting convened by the Association of Health Care Journalists (AHCJ), said that additional data down the road may help determine if the vaccines can prevent transmission.

That data will look at the duration of the viral shedding and the amount of virus in nasopharyngeal swabs or nasal swabs over time. "That will give us a sense of the viral burden in breakthrough cases," said Marston, who noted that those infections have been rare in the Pfizer and Moderna studies.

Pfizer reported 170 infections (162 in the placebo group) in 41,000 participants. Moderna, to date, has reported 95 cases (90 in the placebo group) in 30,000 participants.

The protocols, which are similar for the Pfizer trial and the five COVID-19 vaccines that are part of Warp Speed, will take an eventual look at asymptomatic transmission, Marston said. The studies are also conducting blood draws on participants to determine whether they have antigens that aren't in the vaccine — which would indicate a potential infection at some point.

Corey said that the studies aren't designed to assess transmission. They "don't ask that question and there's really no information on this at this point in time," he said during the APHA/NAM briefing.

"We don't know what's the level of nasal carriage that's required for infection, and the duration of that, and what the vaccine does on that," he said. "It's an important question," especially given that polls have shown a reluctance of many Americans to get vaccinated when a COVID-19 shot becomes available.

NIH Director Francis Collins, MD, told health reporters at the AHCJ event that it will take 80% coverage to get to herd immunity, and that is not likely to happen until summer 2021, "if all goes well," he said, adding that it depends on Americans getting the vaccine.

"One of the greatest tragedies you can imagine in our technological society would be if the science says we can get there, and we have the doses, and a significant proportion of Americans turn them down, and then this epidemic goes on and on and on," he said. "I dearly hope that's not what we're looking at."

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

Medscape Medical News © 2020 

Cite this: Can a CO

 

 People who've had COVID-19 are highly unlikely to contract it again for at least six months after their first infection, according to a British study of healthcare workers on the frontline of the fight against the coronavirus pandemic.

The findings should offer some reassurance for the more than 51 million people worldwide who have been infected with the pandemic disease, researchers at the University of Oxford said.

"This is really good news, because we can be confident that, at least in the short term, most people who get COVID-19 won't get it again," said David Eyre, a professor at Oxford's Nuffield Department of Population Health, who co-led the study.

Isolated cases of re-infection with COVID-19, the disease caused by the SARS-CoV-2 virus, had raised concerns that immunity might be short-lived and that recovered patients may swiftly fall sick again.

But the results of this study, carried out in a cohort of UK healthcare workers - who are among those at highest risk of contracting COVID-19 - suggest cases of reinfection are likely to remain extremely rare.

"Being infected with COVID-19 does offer protection against re-infection for most people for at least six months," Eyre said. "We found no new symptomatic infections in any of the participants who had tested positive for antibodies."

The study, part of a major staff testing programme, covered a 30-week period between April and November 2020. Its results have not peer-reviewed by other scientists but were published before review on the MedRxiv website.

During the study, 89 of 11,052 staff without antibodies developed a new infection with symptoms, while none of the 1,246 staff with antibodies developed a symptomatic infection.

Staff with antibodies were also less likely to test positive for COVID-19 without symptoms, the researchers said, with 76 without antibodies testing positive, compared to only three with antibodies. Those three were all well and did not develop COVID-19 symptoms, they added.

"We will continue to follow this cohort of staff carefully to see how long protection lasts and whether previous infection affects the severity of infection if people do get infected again," Eyre said.

Reuters Health Information © 2020 Reuters Ltd.

Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Cite this: COVID-19 Reinfection Unlikely for at Least 6 Months, Study Fin

 

 

 

Let's say you're exposed to the coronavirus. Maybe you test positive and have mild symptoms, or none at all. And let's say you're working in a short-staffed hospital. Do you stay home? It's actually complicated.

But when it comes to what others should do, it's not complicated. We tell people exactly what the guidelines are.

Think back to when members in the White House were exposed to coronavirus. Doctors blasted social media with CDC recommendations. Many public health experts and doctors called for President Trump to isolate after he tested positive. The Infectious Diseases Society of America recommended that Mike Pence quarantine for 14 days because of his exposure even though he tested negative. Now, they're not essential workers, per se; they are not on the front lines in a hospital or clinic, and this is a politically charged example.

But if we just push that tribal mentality aside, I still want to know if healthcare professionals stand by the same CDC guidelines when it comes to their own exposures or if they're around a close contact.

According to the CDC, a close contact is defined as being within 6 feet of someone who's tested positive for at least 15 minutes, starting 2 days prior to their illness onset. That has happened to so many of us, both in the hospital and out.

Let's say you have been exposed and you're scheduled to work shifts in the hospital. There don't seem to be clear guidelines on what you're supposed to do if you're exposed and you test negative. It kind of depends on who you ask. I've heard of people saying that in this exact situation, they were told to quarantine for 10 days. Others said 72 hours. Others were told that they could go right back to work as long as they didn't have any symptoms. But what if you test positive?

According to the CDC, if you test positive and you're asymptomatic, you can come back to work if it's been 10 days since your test.

If you test positive and you have symptoms, you can come back to work if it's been 10 days since your symptoms first appeared, 24 hours since your last fever, and if your symptoms have improved.

These recommendations kind of concern me because, based on how strained our healthcare system is, I don't know how closely they are adhered to.

I read one story about a nurse who tested positive, was coughing and had GI symptoms, but because she was fever free, she was told to come back to work within 2 days. This sends a terrible message and it adds to the reality of "presenteeism," where people go to work when they are sick, and they shouldn't be there because they can't fully, safely do their jobs.

Now, I don't think healthcare professionals are inherently irresponsible, but for many reasons, many of us do show up to work when we're sick, and there are surveys that demonstrate this. People in healthcare cite a lot of different reasons why they feel pressured to do this. They're afraid of letting down their patients or colleagues, they’re afraid of being criticized, or they're afraid they're going to lose continuity of care.

Also, not every hospital service has backup call or a jeopardy system. Some people have seen pay cuts or lost their PTO, or they feel pressured by administration or their colleagues to go back to work faster than they should. In the end, I really hope our colleagues feel supported enough to say, "Hey, you know what? I've been exposed. I may need to quarantine."

This is a loaded topic. I know. We're still in this pandemic and we're heading into cold and flu season. I want to hear from all of you. What do you think we healthcare professionals should actually be doing if we're exposed or if we test positive and still have mild or no symptoms? Also, what changes need to be made to ensure that our colleagues who are sick actually stay home? Comment below.

Alok S. Patel, MD, is a pediatric hospitalist, television producer, media contributor, and digital health enthusiast. He splits his time between New York City and San Francisco as he is on faculty at both Columbia University/Morgan Stanley Children's Hospital and the University of California San Francisco Benioff Children's Hospital. Alok hosts The Hospitalist Retort video blog on Medscape.

Follow Alok Patel on Twitter

Follow Medscape on Facebook, Twitter, Instagram, and YouTube

© 2020 WebMD, LLC

Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: How Long Should Docs and Nurses With COV

 

 

 

 

Abstract and Introduction

Introduction

Pregnant women might be at increased risk for severe coronavirus disease 2019 (COVID-19).[1,2] The COVID-19-Associated Hospitalization Surveillance Network (COVID-NET)[3] collects data on hospitalized pregnant women with laboratory-confirmed SARS-CoV-2, the virus that causes COVID-19; to date, such data have been limited. During March 1–August 22, 2020, approximately one in four hospitalized women aged 15–49 years with COVID-19 was pregnant. Among 598 hospitalized pregnant women with COVID-19, 54.5% were asymptomatic at admission. Among 272 pregnant women with COVID-19 who were symptomatic at hospital admission, 16.2% were admitted to an intensive care unit (ICU), and 8.5% required invasive mechanical ventilation. During COVID-19–associated hospitalizations, 448 of 458 (97.8%) completed pregnancies resulted in a live birth and 10 (2.2%) resulted in a pregnancy loss. Testing policies based on the presence of symptoms might miss COVID-19 infections during pregnancy. Surveillance of pregnant women with COVID-19, including those with asymptomatic infections, is important to understand the short- and long-term consequences of COVID-19 for mothers and newborns. Identifying COVID-19 in women during birth hospitalizations is important to guide preventive measures to protect pregnant women, parents, newborns, other patients, and hospital personnel. Pregnant women and health care providers should be made aware of the potential risks for severe COVID-19 illness, adverse pregnancy outcomes, and ways to prevent infection.

 

 

 

An infectious disease expert panel cautions against routine use of bamlanivimab (Eli Lilly) and notes that remdesivir (Veklury) can shorten the clinical course of COVID-19 — which could be critical as "as hospitals fill up" across the United States.

The group also said the monoclonal antibodies approved for emergency use by the US Food and Drug Administration (FDA) and still in development hold promise, although more clinical trial data are needed.

These and other recommendations appear in updated guidelines from the Infectious Diseases Society of America (IDSA), released November 18 and 22.

A Conditional 'No' on Routine Bamlanivimab

"The guideline panel gave a conditional recommendation against the routine use of bamlanivimab," Adarsh Bhimraj, MD, co-chair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel, said.

On November 10, the FDA issued an emergency use authorization (EUA) for bamlanivimab for use in ambulatory patients with mild to moderate COVID-19.

Dr Adarsh Bhimraj

"We did have a remark that it may be used in patients who have increased risk of severe COVID-19, as it is outlined in the FDA Emergency Use Authorization [EUA] issued last week," he said. He added that use should follow an informed discussion between provider and patient, one in which "the patient puts a very high value on the uncertain benefits and a low value on uncertain adverse events."

The panel's rationale was based in part on interim analysis of the phase 2 BLAZE-1 trial, which found 1.6% of people randomly assigned to bamlanivimab had an emergency department visit or hospitalization compared with 6.3% of those receiving a placebo.

"We thought the estimate was too fragile because the number in each arm was very low. Even a small change in these numbers could make the difference nonsignificant," said Bhimraj, head of the Neurologic Infectious Diseases Section in the Department of Infectious Diseases at the Cleveland Clinic, Cleveland, Ohio.

Awaiting More Data on Antibody Combination

On November 21, the FDA granted an EUA to the casirivimab and imbdevimab monoclonal antibody combination (Regeneron), indicated to treated mild to moderate COVID-19.

"Surprisingly, the preliminary results released in the EUA look a lot like bamlanivimab," Bhimraj said.

Unlike bamlanivimab, for which trial details were published, the panel does not yet have the totality of data on casirivimab and imbdevimab, and therefore is not yet making a recommendation. "We want to be cautious as a guideline panel. We are anxiously awaiting the full publication," he added.

"I do think these monoclonal antibodies show potential for benefit, but as Dr. Bhimraj said, it's very difficult with the relatively small numbers we're talking about," said Rajesh T. Gandhi, MD, co-chair of the IDSA COVID-19 Treatment and Management Guidelines Expert Panel.

Dr Rajesh Gandhi

Remaining questions include the degree of efficacy these antibody therapies will have, as well as which patients are most likely to benefit, added Gandhi, who is also a professor of medicine at Harvard Medical School and director of HIV Clinical Services and Education at Massachusetts General Hospital in Boston.

Furthermore, although there appear to be adequate supplies of remdesivir and dexamethasone, for example, availability and distribution of monoclonal antibodies could present logistic challenges. Prioritizing which high-risk patients receive this therapy and ensuring equity and access to communities most affected by COVID-19, including minority and low socioeconomic populations, need to be addressed, Gandhi said.  

Remdesivir Recommended to Shorten Hospital Stays

The panel's recommendations regarding the use of remdesivir "has largely remained the same," Gandhi said. Evidence indicates recovery is faster with remdesivir at 10 days vs 15 days in people taking a placebo.

In the ACTT-1 trial, for example, participants in the treatment group recovered in a median 10 days vs 15 days in the placebo group.

Therefore, the IDSA panel continues to recommend remdesivir treatment for hospitalized patients with COVID-19.

"As hospitals around the United States fill up, the IDSA panel believes the effect of remdesivir on speeding up recovery could be an important benefit, and that is why we continue to suggest its use," Gandhi said.

When asked about the World Health Organization-sponsored trial that showed no benefit in terms of mortality, he replied, "Remdesivir is not a home run — we need better drugs."  

A Recommendation Against Lopinavir and Ritonavir

In contrast, the panel recommends against use of the lopinavir/ritonavir protease inhibitor combination therapy, based in part on data from a pre-print of the Solidarity study.

The open-label Solidarity trial in 30 countries, sponsored by WHO, assessed hydroxychloroquine, interferon, lopinavir/ritonavir, and remdesivir in people hospitalized with COVID-19.

None of these drugs showed an effect on mortality, Gandhi said. "Better medicines that improve survival are clearly needed."

Dexamethasone remains the only agent demonstrated to reduce mortality in people hospitalized with COVID-19, he added.

Tocilizumab Not for Routine Use

After critical review of the studies that have emerged since the last IDSA recommendation regarding tocilizumab (Actemra) in September, "the panel still stood with the recommendation against routine use of tocilizumab in hospitalized patients with COVID-19," Bhimraj said.

The guidance is based on trials including COVACTA and EMPACTA. Treatment with tocilizumab was not associated with significant differences in mortality. In these and other studies, "we did not really find a significant difference, and that was the reason for the conditional recommendation against routine use of tocilizumab in hospitalized patients," Bhimraj said.

Also, although the trials were blinded, "we know treatment with tocilizumab can cause a reduction in C-reactive protein levels," which could indicate to researchers which participants were receiving active treatment vs placebo, he said.

Jury Still Out on Baricitinib, Remdesivir Combination

The FDA granted an EUA to the combination of remdesivir and baricitinib (Olumiant) on November 19. However, the IDSA panel is reserving its recommendation on this therapeutic combination until more data emerge.

"We still don't have complete results of the ACTT-2 study, and the information we do have is what is available in the EUA," Bhimraj said. The panel expects to issue guidance once the totality of data become available.

Unanswered questions include why investigators chose a 4 mg dose of baricitinib — twice the 2 mg dose commonly used for treating rheumatoid arthritis — and how many patients in the trial also were treated with steroids.

Gandhi agreed that the proportion of patients taking a steroid is "really an important consideration." He added that dexamethasone has become standard of care because it reduces mortality, as well as the number of people requiring oxygen. He said it will be important to know how the baricitinib/remdesivir combination compares with dexamethasone.

"You don't want to give a drug with less certain benefit over a drug for which there is more certain benefit," Gandhi said.

Future Possibilities

"The monoclonal antibodies are important to continue studying, particularly in combinations," Gandhi said. Researchers are investigating formulations other than IV infusion to make therapy more convenient. For example, a subcutaneous injection like insulin would make administration at home more of a possibility.

Investigators are also looking at oral antiviral therapy, inhaled antivirals, and the promise of using interferon therapy. Gandhi added there is also "a lot of work around medications to reduce the excess inflammation that drives very severe COVID-19."

"Exciting News" on AstraZeneca Vaccine

Although not part of the IDSA guidelines, "we saw the news from AstraZeneca this morning, which is exciting," Gandhi said during a media briefing today.

Unlike the Pfizer and Moderna messenger-RNA vaccines, which use the genetic material of the virus to make the virus proteins that elicit an immune response, the AstraZeneca/Oxford University vaccine uses a viral vector to carry the SARS-CoV-2 protein, to which the body produces an immune response.

"I'm thrilled that several different vaccines are showing important effects at rates higher than the FDA benchmark of 50%, and these are well exceeding that," Gandhi said.

"One interesting thing from the [AstraZeneca] press release is they show asymptomatic infection being reduced," he added. "That is critical because we know a lot of transmission of SARS-CoV-2 comes from asymptomatic people."

Reasons for Optimism

In response to a question about whether the experts feel more optimistic about COVID-19, Bhimraj said he is cautiously optimistic. "We have made tremendous progress in therapeutic agents, and in how the world has come together in the middle of a catastrophe to collaborate, setting our differences apart, to do trials. That is commendable."

Gandhi said he felt more optimistic than he did in the spring. He pointed out that physicians and researchers know a lot more about potential blood clotting complications, how to support patients through severe COVID-19 and keep them off a ventilator whenever possible, and how to provide dexamethasone to reduce the risk of death.

Those benefits are in hospitalized patients, however, and "we need ways to prevent people from getting into the hospital, and that is why we are looking at the monoclonal antibodies," Gandhi said. "If borne out in larger trials, that will be a major advance."

"We need to keep our focus on prevention and go back to our idea of flattening the curve. That is critical so our healthcare systems do not get overwhelmed during this massive surge we are in," Gandhi said. "So masking and social distancing are just as important as they always have been."

Bhimraj has disclosed no relevant financial relationships. Gandhi has no disclosures for the past 12 months; in the past 3 years, he has served on scientific advisory boards for Gilead and Merck.

Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and rheumatology. Follow Damian on Twitter:  @MedReporter.

Αναρτήθηκε από στις
Ετικέτες

Δεν υπάρχουν σχόλια:

Δημοσίευση σχολίου

Εγγραφή σε: Σχόλια ανάρτησης (Atom)