Treatment with the investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50% in at risk, nonhospitalized patients with mild to moderate COVID-19, according to data from the phase 3 MOVe-OUT trial (ClinicalTrials.gov Identifier: NCT04575597).
The planned interim analysis included data from 775 adult patients with mild to moderate COVID-19 and symptom onset within 5 days of randomization. Patients were also required to have at least 1 risk factor associated with poor disease outcomes.
Findings showed that 7.3% (n=28/385) of patients treated with molnupiravir were either hospitalized or died through day 29 following randomization compared with 14.1% (n=53/377) of patients treated with placebo (P =.0012). Additionally, there were no deaths reported in the molnupiravir arm through day 29, compared with 8 deaths in the placebo arm.
Adverse events were found to be comparable between the 2 groups. Fewer patients discontinued treatment due to adverse events in the molnupiravir arm vs the placebo arm (1.3% vs 3.4%).
Based on these positive results, it was recommended that recruitment into the study be stopped early. Merck plans to submit a request for Emergency Use Authorization to the FDA as soon as possible.
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, CEO of Ridgeback Biotherapeutics. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic.”
Merck and Ridgeback’s investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50 percent compared to placebo for patients with mild or moderate COVID-19 in positive interim analysis of phase 3 study. News release. Merck and Ridgeback Biotherapeutics. Accessed October 1, 2021. https://www.businesswire.com/news/home/20211001005189/en/Merck-and-Ridgeback%E2%80%99s-Investigational-Oral-Antiviral-Molnupiravir-Reduced-the-Risk-of-Hospitalization-or-Death-by-Approximately-50-Percent-Compared-to-Placebo-for-Patients-with-Mild-or-Moderate-COVID-19-in-Positive-Interim-Analysis-of-Phase-3-Study.