Outpatient Treatment of Confirmed COVID-19: Living, Rapid Practice Points From the American College of Physicians (Version 1).

Description: Strategies to manage COVID-19 in the outpatient setting continue to evolve as new data emerge on SARS-CoV-2 variants and the availability of newer treatments. The Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) developed these living, rapid practice points to summarize the best available evidence on the treatment of adults with confirmed COVID-19 in an outpatient setting. These practice points do not evaluate COVID-19 treatments in the inpatient setting or adjunctive COVID-19 treatments in the outpatient setting. Methods: The SMPC developed these living, rapid practice points on the basis of a living, rapid review done by the ACP Center for Evidence Reviews at Cochrane Austria at the University for Continuing Education Krems (Danube University Krems). The SMPC will maintain these practice points as living by monitoring and assessing the impact of new evidence. Practice Point 1: Consider molnupiravir to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 to 7 days of the onset of symptoms and at high risk for progressing to severe disease. Practice Point 2: Consider nirmatrelvir-ritonavir combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease. Practice Point 3: Consider remdesivir to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 7 days of the onset of symptoms and at high risk for progressing to severe disease. Practice Point 4: Do not use azithromycin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 5: Do not use chloroquine or hydroxychloroquine to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 6: Do not use ivermectin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 7: Do not use nitazoxanide to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 8: Do not use lopinavir-ritonavir combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 9: Do not use casirivimab-imdevimab combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation. Practice Point 10: Do not use regdanvimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation. Practice Point 11: Do not use sotrovimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation. Practice Point 12: Do not use convalescent plasma to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 13: Do not use ciclesonide to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 14: Do not use fluvoxamine to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.

Excess deaths by sex and Age Group in the first two years of the COVID-19 pandemic in the United States.

The COVID-19 pandemic hastened hundreds of thousands of deaths in the United States. Many of these excess deaths are directly attributed to COVID-19, but others stem from the pandemic's social, economic, and health care system disruptions. This study compares provisional mortality data for age and sex subgroups across different time windows, with and without COVID-19 deaths, and assesses whether mortality risks are returning to pre-pandemic levels. Using provisional mortality reports from the CDC, we compute mortality risks for 22 age and sex subgroups in 2021 and compare against 2015-2019 using odds ratios. We repeat this comparison for the first twelve full months of the COVID-19 pandemic in the United States (April 2020-March 2021) against the next twelve full months (April 2021-March 2022). Mortality risks for most subgroups were significantly higher in 2021 than in 2015-2019, both with and without deaths involving COVID-19. For ages 25-54, Year 2 (April 2021-March 2022) was more fatal than Year 1 (April 2020-March 2021), whereas total mortality risks for the 65 + age groups declined. Given so many displaced deaths in the first two years of the COVID-19 pandemic, mortality risks in the next few years may fall below pre-pandemic levels. Provisional mortality data suggest this is already happening for the 75 + age groups when excluding COVID-19 deaths.

The Development of Living, Rapid Practice Points: Summary of Methods From the Scientific Medical Policy Committee of the American College of Physicians.

In response to the COVID-19 pandemic, the Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) began developing "practice points" to provide clinical advice based on the best available evidence for the public, patients, clinicians, and public health professionals. As one of the first organizations in the United States to develop evidence-based clinical guidelines, ACP continues to lead and advance the science of evidence-based medicine by implementing new methods to rapidly publish practice points and maintain them as living advice that regularly assesses and incorporates new evidence. The overarching aim of practice points is to answer targeted key questions for which there is a timely need to synthesize evidence for decision making. The SMPC believes these methods can potentially be adapted to address various clinical and public health topics beyond the COVID-19 pandemic. This article presents an overview of the SMPC's living, rapid practice points development process, which includes a rapid systematic review, use of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method, use of stringent policies on the disclosure of interests and management of conflicts of interest, incorporating a public (nonclinician) perspective, and maintenance of the documents as living through ongoing surveillance and synthesis of new evidence as it emerges.

Beyond COVID-19 deaths during the COVID-19 pandemic in the United States.

COVID-19 has disrupted society and health care systems, creating a fertile environment for deaths beyond the virus. The year 2020 will prove to be the most deadly year on record in the United States. Direct deaths due to COVID-19 have been well documented and reported. Older people (those over 65) have been hardest hit, with over 80% of the COVID-19 deaths in this age group. What has been less clear is the impact on those under 65 years old, particularly those under 44 years old. This study considers both COVID-19 deaths and non-COVID-19 deaths during a 39 weeks period beginning 1 March in both 2020 and averaged over the five years from 2015 to 2019. Across 22 age and gender cohorts, death risks are compared using odds ratios. The results indicate that younger people (those under 15 years old) have experienced the same or a reduction in death risk between 2020 and the average from 2015 to 2019, suggesting that societal changes were protective for some of them. With all COVID-19 deaths removed from the 2020 death counts, 15-64 year olds experienced increased death risk between 2020 and the 2015 to 2019 average. For example, 15-44 year old males experienced a significant increase in their death risk, even though the absolute number of COVID-19 deaths for this cohort is small. The key take away from this study is that COVID-19 resulted in a large number of additional deaths in 2020 compared to the average from 2015 to 2019, both directly from the virus and indirectly due to societal responses to the virus.