Results from a Phase 3 study evaluating the efficacy and safety of molnupiravir for post-exposure prophylaxis to prevent COVID-19 have been announced.
The multicenter, randomized, double-blind, placebo-controlled MOVe-AHEAD trial (ClinicalTrials.gov identifier: NCT04939428) enrolled over 1500 participants aged 18 years and older who lived in the same household as someone who tested positive for SARS-CoV-2, had at least 1 sign or symptom of COVID-19, and had not had these signs and symptoms for more than 5 days. Individuals who had received the first dose of a COVID-19 vaccine more than 7 days before enrollment, had prior illness with COVID-19 within the past 6 months, or exhibited signs or symptoms of COVID-19 were excluded from the study.
Participants were randomly assigned to receive 800 mg oral molnupiravir or placebo every 12 hours for 5 days. The results showed that while molnupiravir treatment reduced the odds of developing COVID-19 by 23.6% compared to placebo by day 14, the study missed the primary endpoint and did not achieve a statistically significant reduction in the risk of COVID-19 following a household’s exposure to another person with COVID-19.
The safety profile of molnupiravir was consistent with that observed in previous studies and post-approval data for the treatment of COVID-19. Molnupiravir is currently marketed under the brand name Lagevrio and is authorized for emergency use to treat certain adults diagnosed with mild to moderate COVID-19.
“The results of this post-exposure prevention study are scientifically interesting as we continue to learn more about COVID-19,” said Dr. Dean Y. Li, President of Merck Research Laboratories. “This was not a treatment study and these results do not impact the efficacy and safety data observed in our Phase 3 MOVe-OUT trial for the treatment of mild to moderate COVID-19.”
The final analysis of the MOVe-OUT study showed that treatment with molnupiravir reduced the risk of hospitalization or death by 30% in high-risk patients with mild to moderate COVID-19 disease.
reference
Merck provides updates on the Phase 3 MOVe-AHEAD study evaluating Lagevrio (molnupiravir) as post-exposure prophylaxis to prevent COVID-19. Press release. Merck. Accessed February 21, 2023. https://www.businesswire.com/news/home/20230221005404/en/Merck-Provides-Update-on-Phase-3-MOVe-AHEAD-Trial-Evaluating-LAGEVRIO%E2%84%A2-molnupiravir-for-Post-exposure-Prophylaxis-for-Prevention-of-COVID-19.
This article originally appeared on MPR
