Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab

  • N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934.
Anil Gupta  1 ,  Yaneicy Gonzalez-Rojas  1 ,  Erick Juarez  1 ,  Manuel Crespo Casal  1 ,  Jaynier Moya  1 ,  Diego R Falci  1 ,  Elias Sarkis  1 ,  Joel Solis  1 ,  Hanzhe Zheng  1 ,  Nicola Scott  1 ,  Andrea L Cathcart  1 ,  Christy M Hebner  1 ,  Jennifer Sager  1 ,  Erik Mogalian  1 ,  Craig Tipple  1 ,  Amanda Peppercorn  1 ,  Elizabeth Alexander  1 ,  Phillip S Pang  1 ,  Almena Free  1 ,  Cynthia Brinson  1 ,  Melissa Aldinger  1 ,  Adrienne E Shapiro  1 ,  COMET-ICE Investigators
Affiliations
  • 1. From the Albion Finch Medical Centre, William Osler Health Centre, Toronto (A.G.); Optimus U (Y.G.-R.) and Florida International Medical Research (E.J.), Miami, Pines Care Research Center, Pembroke Pines (J.M.), and Sarkis Clinical Trials, Gainesville (E.S.) - all in Florida; Álvaro Cunqueiro Hospital, IIS Galicia Sur, Vigo, Spain (M.C.C.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (D.R.F.); Centex Studies, McAllen (J. Solis), and Central Texas Clinical Research, Austin (C.B.) - both in Texas; Vir Biotechnology, San Francisco (H.Z., A.L.C., C.M.H., J. Sager, E.M., E.A., P.S.P., M.A.); GlaxoSmithKline, Stevenage, United Kingdom (N.S., C.T.); GlaxoSmithKline, Cambridge, MA (A.P.); Pinnacle Research Group, Anniston, AL (A.F.); and the Departments of Global Health and Medicine, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle (A.E.S.).
PMID: 34706189 DOI: 10.1056/NEJMoa2107934
Abstract

Background: Coronavirus disease 2019 (Covid-19) disproportionately results in hospitalization or death in older patients and those with underlying conditions. Sotrovimab is a pan-sarbecovirus monoclonal antibody that was designed to prevent progression of Covid-19 in high-risk patients early in the course of disease.

Methods: In this ongoing, multicenter, double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, nonhospitalized patients with symptomatic Covid-19 (≤5 days after the onset of symptoms) and at least one risk factor for disease progression to receive a single infusion of sotrovimab at a dose of 500 mg or placebo. The primary efficacy outcome was hospitalization (for >24 hours) for any cause or death within 29 days after randomization.

Results: In this prespecified interim analysis, which included an intention-to-treat population of 583 patients (291 in the sotrovimab group and 292 in the placebo group), 3 patients (1%) in the sotrovimab group, as compared with 21 patients (7%) in the placebo group, had disease progression leading to hospitalization or death (relative risk reduction, 85%; 97.24% confidence interval, 44 to 96; P = 0.002). In the placebo group, 5 patients were admitted to the intensive care unit, including 1 who died by day 29. Safety was assessed in 868 patients (430 in the sotrovimab group and 438 in the placebo group). Adverse events were reported by 17% of the patients in the sotrovimab group and 19% of those in the placebo group; serious adverse events were less common with sotrovimab than with placebo (in 2% and 6% of the patients, respectively).

Conclusions: Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified. (Funded by Vir Biotechnology and GlaxoSmithKline; COMET-ICE ClinicalTrials.gov number, NCT04545060.).

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