Sotrovimab, a potential therapeutic agent in fight against COVID-19: NEJM
The study indicates that sotrovimab can be a therapeutic agent for outpatients with Covid-19.
USA: Findings from an interim analysis of the COMET-ICE trial revealed that sotrovimab reduced the risk of disease progression among high-risk patients with mild-to-moderate Covid-19. No safety signals were identified during the trial.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.
The findings of the study were published in The New England Journal of Medicine, on October 27, 2021.
Covid-19 pandemic has reported most hospitalization or death in older patients and those with underlying conditions since its onset. More than 4.8 million people worldwide have died from Covid-19 during the global pandemic. Its management has been challenging for the medical system. In an ongoing, multicenter, double-blind, phase 3 trial, Anil Gupta, and colleagues aimed to evaluate the efficacy and safety of sotrovimab in treating Covid -19.
The researchers randomly assigned, in a 1:1 ratio, non hospitalized 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.
This prespecified interim analysis of the Covid-19 Monoclonal Antibody Efficacy Trial–Intent to Care Early (COMET-ICE) included an intention-to-treat population of 583 patients 291 in the sotrovimab group, and 292 in the placebo group.
The results of the study are:
• 1% i.e 3 patients 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%).
• 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).
Gupta and the team concluded that "among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified."
The study titled, "Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab," is published in the New England Journal of Medicine.