Activist groups state it is premature to declare new standards of care based on results presented by press release – call for data transparency from U.S. agencies
New York City, April 30, 2020 – Treatment Action Group (TAG) and the PrEP4All Collaboration welcome results from randomized controlled trials of therapies for COVID-19, but are seriously concerned about claims that data from a National Institutes of Allergy and Infectious Diseases (NIAID) study of the Gilead drug remdesivir—briefly described yesterday in a press release—justify an instantaneous change to “a new standard of care” for all studies of treatment for COVID-19 disease.
NIAID Director Anthony S. Fauci, M.D., a member of the White House Coronavirus Task Force, implied that based on the recommendation of the study’s Data Safety Monitoring Board (DSMB), remdesivir would be offered to all participants in the placebo arm of the trial.
Our concerns regarding whether this is sufficient cause for remdesivir to become standard of care in all COVID-19 treatment trials are based on the extremely limited amount of data that was disclosed, which precludes clinicians, scientists, and community members from independently assessing the basis for Dr. Fauci’s remarks.
The National Institutes of Health (NIH) has laudably formed a panel of experts to review information on COVID-19 and issue treatment guidelines, with the first iteration published last week. The panel should rapidly review the remdesivir data and make recommendations regarding appropriate usage. This task is not the responsibility of individual officials within the US government.
The limited information released from the NIAID remdesivir trial, which enrolled 1,063 participants, indicate a modest but statistically significant reduction in recovery time in individuals with COVID-19 compared to placebo (11 versus 15 days) and a non-statistically significant trend toward reduced mortality (8% versus 11.6%). The incidence of adverse events and virological results were not reported.
A separate, smaller randomized controlled trial in China involving 237 participants (published in The Lancet yesterday) did not produce significant results, but there was a hint of faster clinical improvement among participants who started remdesivir less than 10 days after symptom onset. No significant effect on SARS-CoV-2 viral load was observed. Adverse events occurred in 66% of remdesivir recipients but the rate was similar in the placebo group (64%). More participants in the remedesivir group discontinued drug due to adverse events (12% versus 5%), although in some cases these events constituted respiratory failure or acute respiratory distress syndrome.
The results appear encouraging, but it is essential that there is careful review of the full results before making decisions about the standard of care for new and ongoing trials for treating COVID-19 disease. Furthermore, studies should not be described by press release with only limited subsets of crucial data included. Full release of a pre-print paper for consideration, alongside peer review, remain the best practices for scientific consideration of new results in this rapidly evolving crisis. Policy and standard of care practices must not be altered by decree without publication and peer review of the data on which these changes are based.
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About TAG: Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus. TAG works to ensure that all people with HIV, TB, and HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.
About PrEP4All: The PrEP4All Collaboration is an activist think tank dedicated to igniting action to put lifesaving HIV medications into the hands of those who need them most.
 National Institutes of Allergy and Infectious Diseases (News Release). NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19. April 29, 2020. https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
 Remarks by President Trump in Meeting with Governor Edwards of Louisiana. 29 April 2020. https://www.whitehouse.gov/briefings-statements/remarks-president-trump-meeting-governor-edwards-louisiana/
 NIH COVID-19 Treatment Guidelines Panel. COVID-19 Treatment Guidelines. April 21, 2020. https://www.covid19treatmentguidelines.nih.gov/introduction/
 Wang Y, Zhang D, Guanhua Du G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. The Lancet. April 29, 2020. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext