Phase 3 Trial to Evaluate Molnupiravir for Treatment of COVID-19 in High-Risk Adults
The MOVe-NOW study will assess the investigational oral antiviral using a different formulation than what is currently approved under an emergency use authorization.
A new phase 3 trial is set to evaluate the investigational oral antiviral molnupiravir (Lagevrio) in adults with COVID-19 who are at high risk for disease progression, Merck announced in a news release.1 The study seeks to build on existing data for molnupiravir and will be used to support global applications for licensure.
Phase 3 Trial to Evaluate Molnupiravir for Treatment of COVID-19 in High-Risk Adults / asauriet - stock.adobe.com
MOVe-NOW is a multicenter, randomized, double-blind, placebo-controlled phase 3 study that is evaluating the efficacy and safety of orally administered molnupiravir compared with placebo in non-hospitalized adults with COVID-19. The trial anticipates enrolling 3082 participants who have had symptoms for 4 days or less and can’t receive nirmatrelvir/ritonavir due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility. The study will be conducted in 25 countries, including the US, France, Japan, Korea, Taiwan, Italy and the United Kingdom.
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The trial will use a different formulation of molnupiravir that includes 2 smaller 400-mg tablets per dose instead of the currently available 4 200-mg capsules per dose. Patients will randomly receive either molnupiravir or placebo every 12 hours for 5 days. The primary efficacy endpoint is the percentage of patients who were hospitalized or died for any reason or had a COVID-19-related medically-attended visit through day 29. Safety endpoints include the percentage of patients with an adverse event and the percentage of patients who discontinued molnupiravir due to an adverse event.
Key secondary endpoints of MOVe-Now include sustained alleviation without relapse of selected participant-reported COVID-19 signs and symptoms through day 29, SARS-CoV-2 viral load, and time to sustained resolution without relapse of COVID-19 signs and symptoms. The study will also include 5 and a half months of follow up to evaluate endpoints associated with long COVID, which will be based on self-reported signs or symptoms.
“COVID-19 remains a leading cause of hospitalization and death around the world, and further studying Lagevrio may provide important insights into how it may be used to help prevent severe outcomes in the current COVID-19 environment,” Paula Annunziato, senior vice president of infectious diseases and vaccines in Global Clinical Development at Merck Research Laboratories, said in a release.1
Molnupiravir is approved for use in the US under emergency use authorization (EUA) to treat mild to moderate COVID-19 in adults at high risk for progression to severe disease and when alternative treatment options are not accessible or clinically appropriate. The EUA approval was based on data from the phase 3 MOVe-OUT trial (NCT04575597), which evaluated the therapy in non-hospitalized adult patients who were unvaccinated against COVID-19, tested positive for SARS-CoV-2, and had at least 1 risk factor associated with poor outcomes.
The study found that, among 1433 patients, molnupiravir reduced the risk of hospitalization or death by 3% compared to placebo through day 29.2 There were 9 deaths reported in the placebo group, compared to 1 in the molnupiravir group. The most common adverse reactions for molnupiravir were diarrhea, nausea, and dizziness. Discontinuation due to an adverse event occurred in 1% of subjects receiving molnupiravir and 3% of subjects receiving placebo.
“We continue to believe Lagevrio may be an important option for people with risk factors like older age, multiple comorbidities, and immunocompromising conditions, who are more likely to advance to severe COVID-19, and for whom other antiviral treatments may not be appropriate because of the potential for drug-drug interactions,” Annunziato said in a release.1
READ MORE: COVID-19 Resource Center
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