In some settings, medical masks may offer similar effectiveness to N95 respirators for preventing COVID-19 infection among health care workers

1. In some settings, medical masks may offer similar effectiveness to N95 respirators for preventing COVID-19 infection among health care workers
Abstract: https://www.acpjournals.org/doi/10.7326/M22-1966
Editorial: https://www.acpjournals.org/doi/10.7326/M22-3219
URL goes live when the embargo lifts
A study of more than 1,000 health care workers was unable to establish whether medical masks are significantly less effective at preventing COVID-19 infection than N95 respirators in hospital settings. The findings varied across countries, which were studied during different times in the pandemic, and uncertainty in the estimates of effect limit definitiveness of findings. The study is published in Annals of Internal Medicine.

Either medical masks or N95 respirators are recommended by the World Health Organization for routine care, whereas only N95 respirators are recommended by the Centers for Disease Control and Prevention for the routine care of patients with COVID-19. It is uncertain if medical masks offer similar protection against COVID-19 compared with N95 respirators.

Researchers from McMaster University studied 1,009 healthcare workers who provided direct care to patients with suspected or confirmed COVID-19 in 29 inpatient or long-term care settings in Canada, Israel, Pakistan, and Egypt. Participants were randomly assigned to universal masking with either a medical mask or a fit-tested N95respirator for 10 weeks. The primary outcome was confirmed COVID-19 on reverse transcriptase polymerase chain reaction (RT-PCR) test. The authors found that confirmed COVID-19 occurred in 10.46 percent of the medical mask group versus 9.27 percent in the N95 respirator group, which ruled out a doubling in hazard of RT-PCR–confirmed COVID-19. However, the results varied by country: 6.11 percent versus 2.22 percent in Canada; 35.29 percent versus 23.53 percent in Israel; 3.26 percent versus 2.13 percent in Pakistan; and 13.62 percent versus 14.56 percent in Egypt. This may have been due to differences in vaccine use, the number of people with previous infection, and the type of variant circulating in the study countries which were enrolled during different times in the pandemic. The authors indicate that while medical masks were found to be not significantly less effective than N95 respirators, and the efficacy estimate was within the noninferiority margin of 2, this margin was wide, and between- country heterogeneity in an unplanned analysis may limit definitive conclusions about noninferiority.

An accompanying editorial by Roger Chou, MD of Oregon Health & Science University highlights that this trial provides the best evidence to date on comparative effectiveness of mask types in preventing COVID-19 infection in health care workers providing routine patient care. The results indicate that medical masks may be similar to N95 respirators in Omicron-era settings with high COVID-19 seroprevalence—but would not have met a more stringent noninferiority threshold. Chou notes that decisions about mask types in health care workers should be informed by the uncertainty around the estimates and continue to account for health care worker preferences about potential trade-offs, N95 respirator availability, and resource constraints.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Mark Loeb, MD, please contact please contact Susan Emigh at emighs@mcmaster.ca or Veronica McGuire at vmcguir@mcmaster.ca.
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 2. ACP issues Rapid, Living Practice Points on treating COVID-19 patients in outpatient settings

Abstract: https://www.acpjournals.org/doi/10.7326/M22-2249
Editorial: https://www.acpjournals.org/doi/10.7326/M22-3317
URL goes live when the embargo lifts

In a new Rapid and Living Practice Points, the American College of Physicians (ACP) summarizes the best available evidence about the use of pharmacologic and biologic treatments of COVID-19 in the outpatient setting. Outpatient Treatment of Confirmed Mild or Moderate COVID-19: Living and Rapid Practice Points from the American College of Physicians (Version 1), is published in Annals of Internal Medicine.

The ACP’s Practice Points focus on patients who can be managed in outpatient settings. Treatments evaluated include antibiotics, antiparasitic agents, antivirals, convalescent plasma, corticosteroids, fluvoxamine and monoclonal antibodies. In the Practice Points, ACP suggests that clinicians consider using the following antiviral treatments in patients with confirmed mild to moderate COVID-19 who are at a high risk for progressing to severe disease:

• Molnupiravir within 5 to 7 days of the onset of symptoms
• Nirmatrelvir-ritonavir combination therapy within 5 days of onset of symptoms
• Remdesivir within 7 days of the onset of symptoms

ACP suggests against the use of certain monoclonal antibodies (casirivimab-imdevimab combination therapy, regdanvimab, sotrovimab) unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation. Finally, ACP suggests against the use of the other reviewed treatments: azithromycin, chloroquine or hydroxychloroquine, convalescent plasma, ciclesonide, fluvoxamine, ivermectin, nitazoxanide, lopinavir-ritonavir combination therapy, or sotrovimab.

The Practice Points note that the informed decision to initiate treatment for COVID-19 in the outpatient setting should be personalized and based on clinical judgment and an informed decision-making approach with the patient on potential treatment benefits, harms, patient level-factors (e.g. risk factors, comorbid conditions, disease severity), and patient preferences.

These Practice Points are based on a systematic review conducted by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Danube University Krems). ACP’s Practice Points are developed by ACP’s Scientific Medical Policy Committee and provide advice to improve the health of individuals and populations and promote high value care based on the best available evidence derived from assessment of scientific work (e.g. clinical guidelines, systematic reviews, individual studies). ACP Practice Points aim to address the value of screening and diagnostic tests and therapeutic interventions for various diseases, and consider known determinants of health, including but not limited to genetic variability, environment, and lifestyle. ACP’s Scientific Medical Policy Committee will maintain these practice points as living by monitoring and assessing the impact of new evidence and updating them as needed.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with someone from ACP, please contact ahachadorian@acponline.org. 

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3. Critical changes in COVID-19 standards of care associated with improved mortality outcomes
Abstract: https://www.acpjournals.org/doi/10.7326/M22-2116
URL goes live when the embargo lifts
An observational study of COVID-19 standard of care (SOC) measures found improvements in recovery and mortality over time in adults hospitalized with COVID-19 and investigated changes in SOC that may explain these improvements. The study is published in Annals of Internal Medicine.

The SOC for patients hospitalized with COVID-19 has evolved rapidly during the pandemic and includes changes in oxygenation practices; airway management; use of prone positioning; anticoagulation practices; and use of antivirals, corticosteroids, and other immunomodulators. These interventions have
affected the morbidity and mortality of patients with COVID-19, but it is difficult to quantify their cumulative effect as the pandemic progresses.

Researchers from the National Institutes of Health and ACTT investigators analyzed clinical outcome data from sequential cohorts of hospitalized patients in the first 4 stages of ACTT (Adaptive COVID-19 Treatment Trial), a series of phase 3 double-blind randomized controlled trials of COVID-19 treatments, to evaluate whether recovery and mortality improved as SOC evolved. Instead of comparing treatment groups within each stage, the authors compared the 3 remdesivir-only groups from the first 3 stages of ACTT. Since ACTT-4 did not include a remdesivir monotherapy arm, recipients of remdesivir + dexamethasone + SOC were compared between ACTT-3 and ACTT-4. The authors found that between ACTT-1 and -2, SOC changes included a dramatic decrease in hydroxychloroquine use and a gradual decrease in empirical antibiotic use. They also found that the odds of baseline intubation in ACTT-2 were 25 percent lower than for comparable ACTT-1 participants. However, they did not find evidence that these changes affected 28-day recovery or mortality. The authors found that recovery and mortality improved from ACTT-2 to ACTT-3. The main observed change in SOC that may explain these improvements was a large increase in the use of dexamethasone. Antibiotics also declined gradually between these stages, but antibiotic use also declined steadily across the other stages without outcome improvements. The authors report no improvements between ACTT-3 and -4 groups. According to the authors, their findings support the exclusion of nonconcurrent controls when analyzing data from platform trials, particularly for COVID-19 treatments and vaccines.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Gail E. Potter, PhD, please contact gail.potter@nih.gov.
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4. Despite fewer overall COVID-19 deaths, more younger people died in second year of the pandemic
Abstract: https://www.acpjournals.org/doi/10.7326/M22-2226
URL goes live when the embargo lifts
A brief research report found that despite 20.8 percent fewer COVID-19 deaths occurring in the second year of the COVID-19 pandemic, 7.4 percent more years of life were lost due to a shift in COVID-19 mortality to relatively younger people. The report is published in Annals of Internal Medicine.

Researchers from Harvard Medical School conducted an analysis of premature mortality caused by the leading causes of death in the United States during the first two years of the COVID-19 pandemic. The authors quantified this shift in mortality age using years of life lost (YLL), which offers an indicator of premature mortality based on the estimated number of years a person would have lived if they had not died prematurely. They found that despite 20.8 percent fewer COVID-19 deaths during March to December 2021 than during March to December 2020, YLL due to COVID-19 increased by 7.4 percent as the age distribution of decedents shifted downward (i.e., relatively younger people were dying). The authors report that YLL per COVID-19 death increased by 35.7 percent but did not change by more than 2.2 percent for any other leading cause of death. According to the authors, understanding this shift in COVID-19 mortality dynamics could inform prevention and treatment approaches, public policy development, and community measures to minimize future effects of COVID-19.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Mark É. Czeisler, PhD, please email Haley Bridger at hbridger@bwh.harvard.edu.
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5. Review concludes that antibodies not a clinically useful measure of protection against SARS-CoV-2 reinfection

Abstract: https://www.acpjournals.org/doi/10.7326/M22-1745 

Based on the final results of a year-long living, rapid review, researchers have definitively concluded that currently available tests to detect SARS-CoV-2 antibodies are not clinically useful as a measure of protection against reinfection. The findings are published in Annals of Internal Medicine.

Researchers from the Agency for Healthcare Research and Quality (AHRQ) synthesized evidence on the SARS-CoV-2 antibody response and reinfection risk with a focus on gaps identified in prior reports. They found that prior infection provided substantial, sustained protection against symptomatic reinfection with the Delta variant and reduced the risk for severe disease due to Omicron variants. They noted that prior infection was less protective against reinfection with Omicron overall, but protection from earlier variants waned rapidly.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Haley K. Holmer, PhD, MPH, please email haley.holmer@va.gov.