Global pharmaceutical company Merck, also referred to as MSD outside the US and Canada, has launched the phase 3 MOVe-NOW clinical trial. The trial aims to assess the effectiveness of Lagevrio (molnupiravir), an investigative oral antiviral medication, in treating Covid-19 patients who are at higher risk of severe disease progression. This diversity-rich, randomized, double-blind, placebo-controlled, international study includes participants aged 18 and above who have tested positive for SARS-CoV-2 within four days of experiencing symptoms and are not hospitalized. Furthermore, the study focuses on adults who are ineligible to receive nirmatrelvir/ritonavir (NMV/r) due to potential drug interactions, allergies, or other challenges, such as accessibility issues.
The MOVe-NOW research will implement a revised version of Lagevrio, featuring two smaller 400-mg tablets per dose (four tablets daily) instead of the existing four 200-mg capsules (eight capsules daily). This new formulation is not approved for use anywhere yet.
“Covid-19 continues to be a major cause of hospitalizations and fatalities globally,” commented Dr. Paula Annunziato, senior vice president of infectious diseases and vaccines at Merck Research Laboratories. “Studying Lagevrio further can offer valuable insights into its potential role in thwarting serious outcomes amid the ongoing pandemic landscape. We are confident that Lagevrio could be crucial for individuals with risk factors such as advancing age, multiple health issues, or compromised immunity, all of whom are more predisposed to severe Covid-19, and for many of whom alternative antiviral treatments aren’t feasible due to drug interactions.” Lagevrio is approved or authorized in various countries, including Japan and Australia, and is conditionally available in the US under an emergency use approval. Over 8.3 million patients have used Lagevrio globally.
MOVe-NOW (MK-4482-023, NCT06667700) represents a phase 3, multi-center, randomized, double-blind, placebo-controlled trial intending to measure the efficacy and safety of orally administered Lagevrio versus placebo in non-hospitalized adults at high risk for Covid-19 progression. The anticipated enrollment is approximately 3,082 participants who will receive either Lagevrio (800 mg) or a placebo orally every 12 hours over five days. Enrollees must be 18 years or older, exhibit positive results for SARS-CoV-2, present Covid-19 symptoms for no more than four days, and be unable to be treated with NMV/r due to interactions, allergies, side effects, or other barriers. This study spans 25 locations worldwide, including the US, Japan, Korea, and several European countries. Researchers may also treat subjects with remdesivir alongside Lagevrio or placebo, depending on clinical judgment and local care standards. Urgent care and hospitalizations, adverse event rates, and sustained alleviation of Covid-19 symptoms are key metrics in the trial. Attention on long-term impacts, including post-acute sequelae of Covid-19, is part of the extended follow-up.
Lagevrio holds emergency use authorization (EUA) to treat adults with mild-to-moderate Covid-19 who face severe progression risks and lack access to FDA-approved alternatives. While not approved fully, Lagevrio use during the pandemic is sanctioned under EUA until further notice. It’s reserved for adult patients not currently hospitalized due to Covid-19 and not intended for more than five consecutive days or pre or post-exposure prevention. Moreover, licensed professionals under applicable state laws can prescribe Lagevrio.