Merck and Ridgeback Biotherapeutics have initiated a Phase III clinical trial to evaluate investigational oral antiviral therapeutic molnupiravir to prevent Covid-19 infection.
For the global MOVe-AHEAD study, individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms, will be enrolled.
Merck Research Laboratories vaccines and infectious diseases, clinical research senior vice-president Dr Nick Kartsonis said: “As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease.
“If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”
Part 2 of the ongoing MOVe-OUT trial is currently evaluating the safety and efficacy of molnupiravir.
The global Phase III, randomised, placebo-controlled, double-blind, multi-site study is evaluating non-hospitalised adult patients with laboratory-confirmed mild to moderate Covid-19 and at least one risk factor associated with poor disease outcomes. The study data is expected in the second half of this year.
The MOVe-AHEAD study will evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of the SARS-CoV-2 virus.
For this trial, around 1,332 participants will be enrolled and randomised to receive either molnupiravir (800mg) or placebo orally every 12 hours for five days.
The trial’s primary endpoints include percentage of participants with Covid-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14.
Other endpoints include percentage of participants with an adverse event and those who discontinued study intervention due to an adverse event.
The trial is being conducted globally in countries including Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain, Turkey, Ukraine, and the US.