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On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the unapproved drug remdesivir to treat hospitalized patients with severe coronavirus disease 2019 (COVID-19). The authorization was based on a preliminary report from a randomized clinical trial in 1063 patients that found that remdesivir shortened the median time to recovery from 15 days to 11 days.1 Anticipating immediate worldwide demand, the maker of remdesivir, Gilead Sciences, donated 1.5 million doses of remdesivir to countries affected by the pandemic, including the US, which received 607 000 doses (enough to treat approximately 100 000 patients). However, the US and other countries have 2 major problems related to this drug. First, the supply of remdesivir is insufficient to treat all eligible patients, which has required hospitals to ration the drug.2 Second, there remain major gaps in knowledge about the efficacy of remdesivir, including whether it reduces mortality and what subgroups of patients may benefit the most.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Douglas B. White, MD, MAS, Program on Ethics and Decision Making in Critical Illness, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, 3550 Terrace St, Scaife Hall, Room 608, HPU010604, Pittsburgh, PA 15261 (firstname.lastname@example.org).
Published Online: June 24, 2020. doi:10.1001/jama.2020.11464
Conflict of Interest Disclosures: Dr White reported receipt of personal fees from the American Thoracic Society and UpToDate Inc. No other disclosures were reported.
Funding/Support: Dr White received funding for this work from National Institutes of Health grant K24 HL148314.
Role of the Funder/Sponsor: The National Institutes of Health had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication.
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