(HealthDay News) — For outpatients with COVID-19 and risk factors for severe disease, REGEN-COV reduces the risk for COVID-19-related hospitalization or death from any cause, according to a study published online Sept. 29 in the New England Journal of Medicine.
David M. Weinreich, M.D., from Regeneron Pharmaceuticals in Tarrytown, New York, and colleagues randomly assigned outpatients with COVID-19 and risk factors for severe disease to receive various doses of intravenous REGEN-COV or placebo.
The researchers found that 1.3 percent of 1,355 patients in the REGEN-COV 2,400-mg group and 4.6 percent of 1,341 in the placebo group had COVID-19-related hospitalization or death from any cause (relative risk reduction, 71.3 percent); among 736 patients in the REGEN-COV 1,200-mg group and 748 in the placebo group, these outcomes occurred in 1.0 and 3.2 percent, respectively (relative risk reduction, 70.4 percent).
With each REGEN-COV dose versus placebo, the median time to resolution of symptoms was four days shorter (10 versus 14 days). Across various subgroups, REGEN-COV was efficacious, including among patients who were severe acute respiratory syndrome coronavirus 2 serum antibody-positive at baseline. Viral load was reduced faster with both REGEN-COV doses versus placebo (least-squares mean difference in viral load from baseline through day 7, −0.71 and −0.86 log10 copies/mL in the 1,200-mg and 2,400-mg groups, respectively).
“The phase 3 clinical outcomes data presented here are consistent with and strengthen these findings showing that early use of REGEN-COV in outpatients with risk factors for severe COVID-19 can lower the risk of hospitalization or death from any cause,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Regeneron Pharmaceuticals; the study was funded by Regeneron Pharmaceuticals and F. Hoffmann-La Roche.