Goldman, Jason D.Lye, David C.B.Hui, David S.Marks, Kristen M.Bruno, RaffaeleMontejano, RocioSpinner, Christoph D.Galli, MassimoAhn, Mi‑YoungNahass, Ronald G.Chen, Yao-ShenSenGupta, DeviHyland, Robert H.Osinusi, Anu O.Cao, HuyenBlair, ChristianaWei, XuelianGaggar, AnujBrainard, Diana M.Towner, William J.Muñoz Gutiérrez, JoséMullane, Kathleen M.Marty, Francisco M.Tashima, Karen T.Diaz, GeorgeSubramanian, ArunaGS-US-540-5773 Investigators2021-02-222021-02-222020-05-270028-4793https://hdl.handle.net/2445/174122Background: 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. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).11 p.application/pdfeng(c) Massachusetts Medical Society, 2020COVID-19Assaigs clínicsCOVID-19Clinical trialsinfo:eu-repo/semantics/article7014862021-02-22info:eu-repo/semantics/openAccess32459919