Evaluating If A New Oral Drug Approved for Use In Britain Protects Unvaccinated Adults Living With People Who Have COVID-19
Bronx, NY –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 Barry Zingman, M.D., the principal investigator for the Montefiore-Einstein site. “If molnupiravir can prevent these vulnerable close contacts from becoming infected, it will save lives.” Dr. Zingman is also professor of medicine at Einstein and clinical director, infectious diseases, at the Moses division of Montefiore Health System.
At present, 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 to 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 5 days.
Half of the participants will take four molnupiravir pills twice daily for 5 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, Dr. Zingman and 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.
About Montefiore Health System
Montefiore Health System is one of New York’s premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 11 hospitals, including the Children’s Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. For more information please visit www.montefiore.org. Follow us on Twitter and view us on Facebook and YouTube.
About Albert Einstein College of Medicine
Albert Einstein College of Medicine is one of the nation’s premier centers for research, medical education and clinical investigation. During the 2020-21 academic year, Einstein is home to 721 M.D. students, 178 Ph.D. students, 109 students in the combined M.D./Ph.D. program, and 265 postdoctoral research fellows. The College of Medicine has more than 1,900 full-time faculty members located on the main campus and at its clinical affiliates. In 2020, Einstein received more than $197 million in awards from the National Institutes of Health (NIH). This includes the funding of major research centers at Einstein in aging, intellectual development disorders, diabetes, cancer, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States through Montefiore and an affiliation network involving hospitals and medical centers in the Bronx, Brooklyn and on Long Island. For more information, please visit einsteinmed.org, read our blog, follow us on Twitter, like us on Facebook, and view us on YouTube.