(HealthDay News) — Sotrovimab reduces the risk for disease progression in high-risk patients with mild-to-moderate COVID-19, according to a study published online Oct. 27 in the New England Journal of Medicine.
Anil Gupta, M.D., from the William Osler Health Center in Toronto, and colleagues randomly assigned nonhospitalized patients with symptomatic COVID-19 and at least one risk factor for disease progression to receive a single infusion of sotrovimab or placebo in an ongoing, multicenter, double-blind, phase 3 trial.
The researchers found that in the prespecified interim analysis in an intention-to-treat population of 583 patients (291 in the sotrovimab group and 292 in the placebo group), 1 and 7 percent of patients in the sotrovimab and placebo groups, respectively, had disease progression leading to hospitalization or death (relative risk reduction, 85 percent). Five patients in the placebo group were admitted to the intensive care unit, including one who died by day 29.
Safety was assessed among 868 patients (430 in the sotrovimab group and 438 in the placebo group). Adverse events were reported by 17 and 19 percent, respectively, while serious adverse events occurred in 2 and 6 percent of patients, respectively.
“Given its in vitro activity against variants of interest and concern, as well as its ability to neutralize other sarbecoviruses, we speculate that sotrovimab has the potential to remain therapeutically active even as severe acute respiratory syndrome coronavirus 2 continues to evolve,” the authors write.
The study was funded by Vir Biotechnology and GlaxoSmithKline; GSK manufactures sotrovimab.