The medical community needs new treatments that can lower the chance of COVID-19 worsening in patients. One emerging, promising treatment is molnupiravir—an oral antiviral.
To evaluate the safety and efficacy of molnupiravir, researchers for the MOVe-OUT Study Group conducted a phase 3, double-blind, randomized, placebo-controlled trial. Study participants began treatment with molnupiravir 5 days after the onset of symptoms. Patients were randomly assigned to receive 800 mg of molnupiravir or placebo twice a day for 5 days.
Participants were non-hospitalized, unvaccinated adults with mild-to-moderate COVID-19 who had at least one risk factor for severe COVID-19. The primary efficacy endpoint was the incidence of hospitalization or death by day 29, and the primary safety endpoint was the incidence of adverse events.
There were a total of 1,433 randomized participants, of which 716 were assigned to receive molnupiravir and 717 to receive placebo. Aside from an imbalance in sex, each group shared similar baseline characteristics.
At the interim analysis, the risk of hospitalization or death through day 29 was significantly lower with molnupiravir. In addition, the percentage of participants who were hospitalized or died through day 29 was lower in the molnupiravir group than in the placebo group. Adverse events occurred in 30% of the molnupiravir group and 33% of the placebo group. Moreover, there were 9 deaths in the placebo group and 1 death in the molnupiravir group by day 29.
Subgroup analysis results were largely consistent with these overall results. However, in some subgroups, such as patients with evidence of previous SARS-CoV-2 infection, those with low baseline viral load, and those with diabetes, the point estimate for the difference favored placebo.
In closing, this study is important because it found that early treatment with molnupiravir lowered the risk of hospitalization or death in unvaccinated, at-risk adults with COVID-19 .
Source: Jayk Bernal, A., Gomes Da Silva, M. M., Musungaie, D. B., Kovalchuk, E., Gonzalez, A., Delos Reyes, V., Martín-Quirós, A., Caraco, Y., Williams-Diaz, A., Brown, M. L., Du, J., Pedley, A., Assaid, C., Strizki, J., Grobler, J. A., Shamsuddin, H. H., Tipping, R., Wan, H., Paschke, A., . . . de Anda, C. (2022). Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients. New England Journal of Medicine, 386(6), 509–520. https://doi.org/10.1056/nejmoa2116044