Early monoclonal antibody treatment of COVID-19 beneficial for high-risk COVID-19 patients

Sotrovimab (GlaxoSmithKline), a monoclonal antibody, appears to reduce the risk of progression of mild-to-moderate cases of COVID-19 in patients at high risk of progression according to Anil Gupta, MD, from the Albion Finch Medical Centre, William Osler Health Centre, Toronto.

Gupta reported the interim study results¹ on behalf of the COVID-19 Monoclonal Antibody Efficacy Trial–Intent to Care Early (COMET-ICE) investigators.

In this ongoing, multicenter, double-blind, phase 3 trial, outpatients with COVID-19 symptoms for 5 days or less who were at high risk for disease progression were randomized to 1 sotrovimab infusion (dose, 500 mg) or placebo.

The primary study outcome was hospitalization for more than 24 hours for any cause or death within 29 days after random assignment.

Interim analysis results
The interim analysis included 583 patients; 291 were randomized to treatment with sotrovimab and 292 to placebo.

Analysis of the primary outcome showed that COVID-19 progressed in 3 patients treated with sotrovimab compared with 21 patients treated with placebo (1% compared with 7%, respectively; p=0.002) leading to hospitalization or death.

The safety analysis included 868 patients, ie, 430 randomized to sotrovimab and 438 to placebo; 17% and 19%, respectively, reported adverse events; serious adverse events occurred less frequently with sotrovimab (2%) compared with placebo (6%), the investigators reported.

Based on these results, Gupta and colleagues concluded that in this high-risk population of patients with mild-to-moderate cases of COVID-19, sotrovimab reduced the risk of disease progression and no safety signals were identified.

“The results of this interim analysis of COMET-ICE indicate that sotrovimab can be a therapeutic agent for outpatients with COVID-19,” the investigators wrote. “Notably, a 500-mg dose may also permit intramuscular administration, which may increase the convenience of and access to therapeutic antibody agents for patients with COVID-19. Studies are currently under way to evaluate this route of administration.”

Reference

1 Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med; published on October 27, 2021.