tetano
Editor, Senior Moderator
N Engl J Med
. 2021 Oct 27.
doi: 10.1056/NEJMoa2107934. Online ahead of print.
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Anil Gupta[SUP] 1 [/SUP], Yaneicy Gonzalez-Rojas[SUP] 1 [/SUP], Erick Juarez[SUP] 1 [/SUP], Manuel Crespo Casal[SUP] 1 [/SUP], Jaynier Moya[SUP] 1 [/SUP], Diego R Falci[SUP] 1 [/SUP], Elias Sarkis[SUP] 1 [/SUP], Joel Solis[SUP] 1 [/SUP], Hanzhe Zheng[SUP] 1 [/SUP], Nicola Scott[SUP] 1 [/SUP], Andrea L Cathcart[SUP] 1 [/SUP], Christy M Hebner[SUP] 1 [/SUP], Jennifer Sager[SUP] 1 [/SUP], Erik Mogalian[SUP] 1 [/SUP], Craig Tipple[SUP] 1 [/SUP], Amanda Peppercorn[SUP] 1 [/SUP], Elizabeth Alexander[SUP] 1 [/SUP], Phillip S Pang[SUP] 1 [/SUP], Almena Free[SUP] 1 [/SUP], Cynthia Brinson[SUP] 1 [/SUP], Melissa Aldinger[SUP] 1 [/SUP], Adrienne E Shapiro[SUP] 1 [/SUP], COMET-ICE Investigators
Affiliations
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.).
. 2021 Oct 27.
doi: 10.1056/NEJMoa2107934. Online ahead of print.
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Anil Gupta[SUP] 1 [/SUP], Yaneicy Gonzalez-Rojas[SUP] 1 [/SUP], Erick Juarez[SUP] 1 [/SUP], Manuel Crespo Casal[SUP] 1 [/SUP], Jaynier Moya[SUP] 1 [/SUP], Diego R Falci[SUP] 1 [/SUP], Elias Sarkis[SUP] 1 [/SUP], Joel Solis[SUP] 1 [/SUP], Hanzhe Zheng[SUP] 1 [/SUP], Nicola Scott[SUP] 1 [/SUP], Andrea L Cathcart[SUP] 1 [/SUP], Christy M Hebner[SUP] 1 [/SUP], Jennifer Sager[SUP] 1 [/SUP], Erik Mogalian[SUP] 1 [/SUP], Craig Tipple[SUP] 1 [/SUP], Amanda Peppercorn[SUP] 1 [/SUP], Elizabeth Alexander[SUP] 1 [/SUP], Phillip S Pang[SUP] 1 [/SUP], Almena Free[SUP] 1 [/SUP], Cynthia Brinson[SUP] 1 [/SUP], Melissa Aldinger[SUP] 1 [/SUP], Adrienne E Shapiro[SUP] 1 [/SUP], COMET-ICE Investigators
Affiliations
- 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.).