The 2 companies will examine molnupiravir (Lagevrio) using a different formulation that is not approved in any country globally.
Image credit: Merck
This morning, Merck and Ridgeback Biotherapeutics announced they were launching their MOVe-NOW phase 3 trial to evaluate their COVID-19 antiviral, molnupiravir, using a different regimen and formulation. This study will have participants take 2 smaller 400-mg tablets per dose (4 daily tablets) instead of the current regimen of 4 200-mg capsules per dose, which equates to 8 daily capsules.
“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,” Paula Annunziato, MD, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, said in a statement.
The study uses a revised regimen (two 400-mg tablets per dose) to evaluate its efficacy and safety in preventing severe COVID-19 outcomes.
The trial focuses on non-hospitalized adults at high risk for severe COVID-19 progression who cannot take other antivirals like nirmatrelvir/ritonavir.
With approximately 3,082 participants, it features a 5.5-month follow-up to explore sustained recovery and long-term effects of COVID-19.
MOVe-NOW is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared with placebo in non-hospitalized adults with COVID-19 at high risk for disease progression.They are looking to enroll approximately 3,082 participants who will either receive either molnupiravir (800 mg) or placebo orally every 12 hours for 5 days.
Inclusion criteria for the trial must participants be 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 4 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 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 molnupiravir 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.
This global study will be conducted in 25 countries including the US, Japan, Korea, Taiwan, the United Kingdom, France, Italy, Spain, Ukraine, Poland, Mexico, Colombia, and other countries.
Investigators may treat some participants with concomitant remdesivir, if available and clinically appropriate per local clinical practice, as local standard of care in addition to molnupiravir or placebo. The study will also have an extended follow up of approximately 5 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 (ie, Day 56, Day 112, and Day 168) based on self-reported COVID-19 signs/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,” said Annunziato.
