Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab.
N Engl J Med
; 385(21): 1941-1950, 2021 11 18.
Article
in En
| MEDLINE
| ID: mdl-34706189
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 11 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.).
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Disease Progression
/
Antibodies, Neutralizing
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Antibodies, Monoclonal, Humanized
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SARS-CoV-2
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COVID-19 Drug Treatment
Type of study:
Clinical_trials
/
Etiology_studies
/
Incidence_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Adult
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Aged
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Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
N Engl J Med
Year:
2021
Document type:
Article