Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
M.D Jason D Goldman, M.P.H David C B Lye, B.S David S Hui, M.D Kristen M Marks, M.D Raffaele Bruno, M.D Rocio Montejano, M.D Christoph D Spinner, M.D Massimo Galli, M.D Mi-Young Ahn, M.D Ronald G Nahass, M.D Yao-Shen Chen, M.D Devi Sengupta, M.D Robert H Hyland, M.D Anu O Osinusi, M.D Huyen Cao, M.S Christiana Blair, Ph.D Xuelian Wei, M.D Anuj Gaggar, Ph.D Diana M Brainard, M.D William J Towner, M.D Jose Muñoz, M.D Kathleen M Mullane, Pharm.D Francisco M Marty, M.D Karen T Tashima, M.D George Diaz, M.D Aruna Subramanian
New England Journal of Medicine, doi:10.1056/nejmoa2015301
BACKGROUND Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19).
METHODS We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale.
RESULTS In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%).
CONCLUSIONS In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined.
Acute respiratory distress syndrome 1 (<1) 5 Respiratory distress 3
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