Iinitiation of a phase III MOVe-NOW clinical trial to evaluate Lagrvrio (molnupiravir), for the treatment of adults with COVID-19 at high risk for disease progression

This double-blind, placebo-controlled, global study is enrolling individuals who are at least 18 years of age, tested positive for SARS-CoV-2 infection, have had COVID-19 symptoms for four days or less, and are not hospitalized. Additionally, the study will only enroll adults who cannot receive nirmatrelvir/ritonavir (NMV/r) due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility.

The MOVe-NOW study will use a different formulation of  Lagrvrio that includes two smaller 400-mg tablets per dose (four daily tablets) instead of the currently available four 200-mg capsules per dose (eight daily capsules). The smaller tablets are not currently approved for use in any country. For more information on the trial, visit clinicaltrials.gov.

“COVID-19 remains a leading cause of hospitalization and death around the world, and further studyingLagevrio  may provide important insights into how it may be used to help prevent severe outcomes in the current COVID-19 environment,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories. “We continue to believe Lagrvrio 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.”

Lagrvrio is approved or authorized for use in several countries, including Japan, Australia, and available for use in the United States under emergency use authorization, for the treatment of certain adults who have been diagnosed with COVID-19. To date, Lagrvrio has been used by more than 8.3 million patients worldwide.

About the MOVe-NOW Study; MOVe-NOW (MK-4482-023, NCT06667700 ) is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered Lagrvrio compared with placebo in non-hospitalized adults with COVID-19 at high risk for disease progression. The trial is anticipated to enroll approximately 3,082 participants who will be randomized to receive either Lagrvrio (800 mg) or placebo orally every 12 hours for five days. The study will enroll participants who are at least 18 years of age and have received a positive test for SARS-CoV-2 infection with signs or symptoms attributable to COVID-19 for four days or less and will only enroll adults who cannot receive nirmatrelvir/ritonavir (NMV/r) due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility. The trial is being conducted in 25 markets around the world, including the United States, Japan, Korea, Taiwan, the United Kingdom, France, Italy, Spain, Ukraine, Poland, Mexico, and Colombia, among others.

Investigators may decide to treat some study participants with concomitant remdesivir, if available and clinically appropriate per local clinical practice, as local standard of care in addition to Lagrvrio or placebo. Study investigators should aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care.

The primary efficacy and safety endpoints of the trial include the percentage of participants who were hospitalized or died for any reason or had a COVID-19-related medically-attended visit through Day 29; the percentage of participants with an adverse event; and the percentage of participants who discontinued Lagrvrio due to an adverse event.

A key secondary endpoint is sustained alleviation without relapse of selected participant-reported COVID-19 signs and symptoms through Day 29. Additional secondary endpoints through Day 29 include evaluation of SARS-CoV-2 viral load, time to sustained resolution without relapse of COVID-19 signs and symptoms, and percentage of participants with clinically important medical interventions associated with a COVID-19-related medically attended visit or hospitalization, or who experienced hospitalization or death due to any cause. The study includes an extended follow up of approximately five and a half months after treatment ends to evaluate endpoints associated with post-acute sequelae of COVID-19 (PASC, or long COVID). Development of PASC will be assessed on Day 29 and during the extended follow-up period (i.e., Day 56, Day 112, and Day 168) based on self-reported COVID-19 signs/symptoms