HealthDay News — For nonhospitalized, unvaccinated adults with mild-to-moderate COVID-19 and at least one risk factor for severe disease, molnupiravir reduces the risk for hospitalization or death, according to a study published online Dec. 16 in the New England Journal of Medicine.
Angélica Jayk Bernal, M.D., from IMAT Oncomédica in Monteria, Colombia, and colleagues conducted a phase 3, double-blind, randomized trial to examine the efficacy and safety of molnupiravir treatment started within five days after onset of signs or symptoms in nonhospitalized, unvaccinated adults with mild-to-moderate laboratory-confirmed COVID-19. The 1,433 participants, who had at least one risk factor for severe COVID-19 illness, were randomly assigned to receive either molnupiravir or placebo twice daily for five days (716 and 717, respectively).
The researchers found that at the interim analysis, the superiority of molnupiravir was demonstrated; the risk for hospitalization for any cause or death through day 29 was lower with molnupiravir versus placebo (7.3 versus 14.1 percent; difference, −6.8 percentage points). In an analysis of all participants who had undergone randomization, the percentage of patients who were hospitalized or died through day 29 was also lower in the molnupiravir versus the placebo group (6.8 versus 9.7 percent; difference, −3.0 percentage points). Subgroup analyses results were mainly similar to the overall results. Through day 29, there was one death reported in the molnupiravir group and nine in the placebo group. Adverse events were reported in 30.4 and 33.0 percent of the molnupiravir and placebo groups, respectively.
“Vaccines must be the primary mode of protection against SARS-CoV-2; however, orally bioavailable medications will become an essential tool for physicians in the management of this horrible disease,” writes the author of an accompanying editorial.
Several study authors and the author of the editorial disclosed financial ties to pharmaceutical companies, including Merck, the manufacturer of molnupiravir.