New England Journal of Medicine, volume 385, issue 21, pages 1941-1950
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Anil K. 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 J. A. Scott
1
,
A J. 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
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...
Publication type: Journal Article
Publication date: 2021-10-27
Journal:
New England Journal of Medicine
Quartile SCImago
Q1
Quartile WOS
Q1
Impact factor: 158.5
ISSN: 00284793, 15334406
General Medicine
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.).
Top-30
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- We do not take into account publications without a DOI.
- Statistics recalculated only for publications connected to researchers, organizations and labs registered on the platform.
- Statistics recalculated weekly.
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Gupta A. K. et al. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab // New England Journal of Medicine. 2021. Vol. 385. No. 21. pp. 1941-1950.
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Gupta A. K., Gonzalez-Rojas Y., Juarez E., Crespo Casal M., Moya J., Falci D. R., Sarkis E., Solis J., Zheng H., Scott N. J. A., Cathcart A. J., 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. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab // New England Journal of Medicine. 2021. Vol. 385. No. 21. pp. 1941-1950.
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TY - JOUR
DO - 10.1056/NEJMoa2107934
UR - https://doi.org/10.1056/NEJMoa2107934
TI - Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
T2 - New England Journal of Medicine
AU - Gonzalez-Rojas, Yaneicy
AU - Juarez, Erick
AU - Crespo Casal, Manuel
AU - Moya, Jaynier
AU - Sarkis, Elias
AU - Solis, Joel
AU - Zheng, Hanzhe
AU - Hebner, Christy M.
AU - Sager, Jennifer
AU - Mogalian, Erik
AU - Tipple, Craig
AU - Peppercorn, Amanda
AU - Alexander, Elizabeth
AU - Pang, Phillip S.
AU - Free, Almena
AU - Aldinger, Melissa
AU - Shapiro, Adrienne E.
AU - Gupta, Anil K.
AU - Falci, Diego R.
AU - Scott, Nicola J. A.
AU - Cathcart, A J.
AU - Brinson, Cynthia
PY - 2021
DA - 2021/10/27 00:00:00
PB - NEJM Group
SP - 1941-1950
IS - 21
VL - 385
SN - 0028-4793
SN - 1533-4406
ER -
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@article{2021_Gupta,
author = {Yaneicy Gonzalez-Rojas and Erick Juarez and Manuel Crespo Casal and Jaynier Moya and Elias Sarkis and Joel Solis and Hanzhe Zheng and Christy M. Hebner and Jennifer Sager and Erik Mogalian and Craig Tipple and Amanda Peppercorn and Elizabeth Alexander and Phillip S. Pang and Almena Free and Melissa Aldinger and Adrienne E. Shapiro and Anil K. Gupta and Diego R. Falci and Nicola J. A. Scott and A J. Cathcart and Cynthia Brinson},
title = {Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab},
journal = {New England Journal of Medicine},
year = {2021},
volume = {385},
publisher = {NEJM Group},
month = {oct},
url = {https://doi.org/10.1056/NEJMoa2107934},
number = {21},
pages = {1941--1950},
doi = {10.1056/NEJMoa2107934}
}
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Gupta, Anil K., et al. “Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab.” New England Journal of Medicine, vol. 385, no. 21, Oct. 2021, pp. 1941-1950. https://doi.org/10.1056/NEJMoa2107934.
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