HealthDay News — For nonhospitalized patients with symptomatic mild-to-moderate COVID-19 and a high risk for progression, risk for all-cause hospitalization or death is reduced with sotrovimab versus placebo, according to a study published online March 14 in the Journal of the American Medical Association.
Anil Gupta, M.D., from the William Osler Health Centre in Toronto, and colleagues randomly assigned nonhospitalized patients with symptomatic, mild-to-moderate COVID-19 and at least one risk factor for progression to an intravenous infusion with either sotrovimab or placebo (528 and 529 patients, respectively). At the prespecified interim analysis, enrollment was stopped early for efficacy.
The researchers observed a significant reduction in all-cause hospitalization lasting longer than 24 hours or death through day 29 with sotrovimab versus placebo (1 versus 6 percent; adjusted relative risk, 0.21). Four of the five secondary outcomes were significantly in favor of sotrovimab, including decreased emergency department visits, hospitalizations, or deaths and reduced progression to severe or critical respiratory COVID-19 (adjusted relative risks, 0.34 and 0.26, respectively). Adverse events occurred infrequently and were similar between the groups (22 and 23 percent for sotrovimab and placebo, respectively).
“The findings support sotrovimab as a treatment option for nonhospitalized, high-risk patients with mild-to-moderate COVID-19, although efficacy against severe acute respiratory syndrome coronavirus 2 variants that have emerged since the study was completed is unknown,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Vir Biotechnology and GlaxoSmithKline, which manufacture sotrovimab and funded the study.