As part of a recently launched international phase 3 clinical trial, Montefiore Health System and Albert Einstein College of Medicine are investigating whether the Merck antiviral pill, molnupiravir, now approved in Britain for treating COVID-19, can prevent COVID-19 in unvaccinated individuals living with people who have contracted the disease.
Montefiore-Einstein is the first and only New York State site for the trial and was selected due to its diverse patient population and expertise in clinical trials of COVID-19 and other infectious diseases.
Merck recently announced that people with mild or moderate cases of COVID-19 who took molnupiravir reduced their risk of hospitalization and death by approximately 50%. Today, Britain approved the drug for treating the coronavirus, noting it is “safe and effective;” it is the first oral medication approved for patients with COVID-19.
“Based on results of a recent Centers for Disease Control and Prevention study involving the highly transmissible delta variant, we estimate that unvaccinated people living with a person with COVID-19 have a high risk—as great as an 80% to 100% chance—of becoming infected, regardless of their age or preexisting conditions,” said Dr. Barry Zingman, the principal investigator for the Montefiore-Einstein site. “If molnupiravir can prevent these vulnerable close contacts from becoming infected, it will save lives.” Zingman is also professor of medicine at Einstein and clinical director, infectious diseases, at the Moses Division of Montefiore Health System.
Currently, the only drugs used to prevent COVID-19 are monoclonal antibody (mAb) therapies; all must be infused into the bloodstream in a clinic or physician’s office. Although molnupiravir has not yet been approved for treating or preventing COVID-19, the new antiviral pills could potentially have a bigger impact than the mAb therapies, since the pills may be more accessible to more people, may work across different viral variants without needing to be redesigned and should be less expensive.
The randomized, double-blind, placebo-controlled molnupiravir study will include about 1,300 people at 114 sites globally; the Montefiore-Einstein site will enroll between 10-20 people. All participants must be aged 18 or older, be completely unvaccinated, exhibit no COVID-19 symptoms, and share a household with someone known to have tested positive for COVID-19 within the previous five days.
Half of the participants will take four molnupiravir pills twice daily for five days, while the other participants will receive the same number of placebo pills over that time. Two and four weeks after the start of treatment, Zingman and his colleagues will determine the percentage of participants in the two groups who develop COVID-19. All participants will be counseled on the benefits of COVID-19 vaccination to prevent future infections. The trial is expected to end in April.
Molnupiravir works through deception — its molecules are absorbed by virus-infected cells and converted into defective RNA “building blocks.” Viral enzymes unwittingly use these defective building blocks to construct the genetic material of newly minted viruses, which now can no longer reproduce. Since COVID-19 viral variants and other RNA viruses use the same basic building blocks, a hope is that molnupiravir might work against the virus that causes COVID-19 and possibly other viral infections as well.