Merck, in collaboration with Ridgeback Biotherapeutics, has launched a Phase 3 clinical trial, named MOVe-NOW, to evaluate the efficacy and safety of Lagevrio (molnupiravir) in treating high-risk adults with COVID-19. This global, double-blind, placebo-controlled study aims to enroll 3,082 non-hospitalized participants who have tested positive for SARS-CoV-2, exhibit COVID-19 symptoms for no more than four days, and cannot receive nirmatrelvir/ritonavir due to drug interactions, allergies, prior adverse reactions, or inaccessibility. The trial is being conducted across 25 markets worldwide.
Trial Design and Objectives
The MOVe-NOW trial (MK-4482-023, NCT06667700) will assess a new formulation of Lagevrio, involving two 400-mg tablets per dose (four daily) instead of the current four 200-mg capsules (eight daily). Participants will be randomized to receive either Lagevrio (800 mg) or a placebo orally every 12 hours for five days. The primary endpoint is the percentage of participants hospitalized, deceased, or requiring a COVID-19-related medically-attended visit through Day 29. Safety endpoints include adverse events and discontinuations due to adverse events.
Key secondary endpoints include sustained alleviation of COVID-19 signs and symptoms without relapse through Day 29, SARS-CoV-2 viral load evaluation, and time to sustained resolution of symptoms. The study also incorporates a 5.5-month follow-up to assess post-acute sequelae of COVID-19 (PASC), commonly known as long COVID.
Inclusion Criteria and Treatment Options
Eligible participants must be at least 18 years old and have confirmed SARS-CoV-2 infection with attributable symptoms for four days or less. The trial specifically targets individuals for whom nirmatrelvir/ritonavir is not a viable option. Investigators may also administer concomitant remdesivir to some participants, based on local clinical practice and availability.
Current Status and Global Use of Lagevrio
Lagevrio is currently authorized for emergency use in the United States for adults with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease and for whom alternative treatments are not accessible or clinically appropriate. It is also approved or authorized in countries including Japan and Australia. To date, Lagevrio has been used to treat over 8.3 million patients globally.
Expert Commentary
Dr. Paula Annunziato, Senior Vice President, Infectious Diseases and Vaccines, Global Clinical Development, Merck Research Laboratories, stated, "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. 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."
