Gilead Sciences began accepting requests from clinicians for compassionate use of remdesivir on January 25, 2020. To submit a request, clinicians completed an assessment form with demographic and disease-status information about their patient (see the Supplementary Appendix, available with the full text of this article at NEJM.org). Approval of requests was reserved for hospitalized patients who had SARS-CoV-2 infection confirmed by reverse-transcriptase–polymerase-chain-reaction assay and either an oxygen saturation of 94% or less while the patient was breathing ambient air or a need for oxygen support. In addition, patients were required to have a creatinine clearance above 30 ml per minute and serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than five times the upper limit of the normal range, and they had to agree not to use other investigational agents for Covid-19.
In approved cases, the planned treatment was a 10-day course of remdesivir, consisting of a loading dose of 200 mg intravenously on day 1, plus 100 mg daily for the following 9 days. Supportive therapy was to be provided at the discretion of the clinicians. Follow-up was to continue through at least 28 days after the beginning of treatment with remdesivir or until discharge or death. Data that were collected through March 30, 2020, are reported here. This open-label program did not have a predetermined number of patients, number of sites, or duration. Data for some patients included in this analysis have been reported previously.20-22 Details of the study design and conduct can be seen in the protocol (available at NEJM.org).