Cited by 1,086SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesRespiratory viral infections research

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

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Gupta, Anil, Gonzalez-Rojas, Yaneicy, Juarez, Erick, Crespo Casal, Manuel, Moya, Jaynier, Falci, Diego R., Sarkis, Elias, Solis, Joel, Zheng, Hanzhe, Scott, Nicola, Cathcart, Andrea L., Hebner, Christy M., Sager, Jennifer, Mogalian, Erik, Tipple, Craig, Peppercorn, Amanda, Alexander, Elizabeth, Pang, Phillip S., Free, Almena, Brinson, Cynthia, Aldinger, Melissa, Shapiro, Adrienne E.·2021·New England Journal of Medicine

DOI 10.1056/nejmoa2107934

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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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Authors: Gupta, A., Gonzalez-Rojas, Y., Juarez, E., Crespo Casal, M., Moya, J., Falci, D. R., Sarkis, E., Solis, J., Zheng, H., Scott, N., Cathcart, A. L., Hebner, C. M., Sager, J., Mogalian, E., Tipple, C., Peppercorn, A., Alexander, E., Pang, P. S., Free, A., Brinson, C., Aldinger, M., & Shapiro, A. E.
Affiliations: William Osler Health System (CA)
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.).
Hospital de Clínicas de Porto Alegre (BR)
The University of Texas at Austin (US)
VIR Biotechnology (United States) (US)
GlaxoSmithKline (United Kingdom) (GB)
GlaxoSmithKline (United States) (US)
University of Washington (US)
Corresponding author: Shapiro, Adrienne E.
ORCID: Pang, Phillip S.
Shapiro, Adrienne E.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2021-11-18
Volume: 385
Issue: 21
Pages: 1941-1950
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2107934
OpenAlex: W3208080692
Cited by: 1,086
References: 25
Citations by year: 2026: 25 · 2025: 72 · 2024: 119 · 2023: 294 · 2022: 509 · 2021: 62
FWCI: 78.13
Type: journal article
Language: en
Open access: green
doi.org
Licence: cc-by-nc-nd
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
medRxiv (acceptedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Funders: Vir Biotechnology, Inc., in collaboration with GlaxoSmithKline
Topics: Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
Keywords: sotrovimab, COVID-19 pandemic, SARS-CoV-2, neutralizing monoclonal antibodies, early treatment, disease progression, hospitalization, mortality, high-risk patients, non-hospitalized patients, presymptomatic treatment, adverse events
MeSH terms: SARS-CoV-2, COVID-19 Drug Treatment, Adult, Aged, Ambulatory Care, Double-Blind Method, Female, Hospitalization, Humans, Infusions, Intravenous, Length of Stay, Male, Middle Aged, Incidence, Disease Progression, Antibodies, Neutralizing, Intention to Treat Analysis, Antibodies, Monoclonal, Humanized

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