• Richard D Shih, Dennis G Maki, and Charles H Hennekens.
• Charles E. Schmidt College of Medicine, Florida Atlantic University, Departments of Emergency Medicine, Bethesda Hospital East and Delray Medical Center, USA.
• Contemp Clin Trials Commun. 2020 Dec 1; 20: 100663.

AbstractFrom December 2019 to May 22, 2020 the emerging and ever-increasing pandemic of coronavirus 19 (COVID-19) had no effective and safe treatment. Not surprisingly, remdesivir attracted worldwide attention. In a trial published online ahead of print, of 1063 patients, 541 were assigned at random to remdesivir and 522 to placebo. The primary prespecified endpoint was mean recovery time and patients assigned to remdesivir had a mean recovery time of 11 days versus 15 days for those assigned a random to placebo. (p < 0.001). With respect to mortality, the prespecfied secondary endpoint, 34/538 patients in remdesivir and 54/521 in placebo died after 28 days, yielding a possible 31% reduction that approached but did not achieve statistical significance (p = 0.059). The only other published trial of remdesivir randomized 237 patients in China. In that trial, 178 patients were assigned at random to remdesivir compared to 79 assigned to placebo. Those assigned at random to remdesivir experienced a possible but nonsignificant 23% faster time to clinical improvement of 21 days compared with 23 for those assigned to placebo [hazard ratio 1.23 [95% CI, 0·87-1.75)]. With respect to mortality there was no suggestion of any benefit. In fact, the mortality rate in those receiving remdesivir was 15% (22/150) compared with 13% (10/77) for those assigned to placebo. Ongoing randomized trials should be designed, conducted and analyzed to provide the necessary reliable data on mortality to resolve the remaining clinical uncertainties.© 2020 The Authors.

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