• Robert L Gottlieb, Carlos E Vaca, Roger Paredes, Jorge Mera, Brandon J Webb, Gilberto Perez, Godson Oguchi, Pablo Ryan, Bibi U Nielsen, Michael Brown, Ausberto Hidalgo, Yessica Sachdeva, Shilpi Mittal, Olayemi Osiyemi, Jacek Skarbinski, Kavita Juneja, Robert H Hyland, Anu Osinusi, Shuguang Chen, Gregory Camus, Mazin Abdelghany, Santosh Davies, Nicole Behenna-Renton, Frank Duff, Francisco M Marty, Morgan J Katz, Adit A Ginde, Samuel M Brown, Joshua T Schiffer, Joshua A Hill, and GS-US-540-9012 (PINETREE) Investigators.
• From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).
• N. Engl. J. Med. 2022 Jan 27; 386 (4): 305-315.

BackgroundRemdesivir improves clinical outcomes in patients hospitalized with moderate-to-severe coronavirus disease 2019 (Covid-19). Whether the use of remdesivir in symptomatic, nonhospitalized patients with Covid-19 who are at high risk for disease progression prevents hospitalization is uncertain.MethodsWe conducted a randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions). Patients were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or placebo. The primary efficacy end point was a composite of Covid-19-related hospitalization or death from any cause by day 28. The primary safety end point was any adverse event. A secondary end point was a composite of a Covid-19-related medically attended visit or death from any cause by day 28.ResultsA total of 562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%). Covid-19-related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.03 to 0.59; P = 0.008). A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19-related medically attended visit by day 28 (hazard ratio, 0.19; 95% CI, 0.07 to 0.56). No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.ConclusionsAmong nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. (Funded by Gilead Sciences; PINETREE ClinicalTrials.gov number, NCT04501952; EudraCT number, 2020-003510-12.).Copyright © 2021 Massachusetts Medical Society.

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