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  • Sotrovimab, a...

Sotrovimab, a potential therapeutic agent in fight against COVID-19: NEJM

Written By : MD Editorial Team |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2021-11-02T09:15:41+05:30  |  Updated On 2 Nov 2021 9:15 AM IST
Sotrovimab, a potential therapeutic agent in fight against COVID-19: NEJM
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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."

Reference:

The study titled, "Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab," is published in the New England Journal of Medicine.

DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2107934


sotrovimabCOVID-19NEJM
Source : New England Journal of Medicine
MD Editorial Team
MD Editorial Team

    Medical Dialogues consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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