As part of a recently launched international phase 3 clinical trial, officials at Montefiore Health System and the Albert Einstein College of Medicine announced on Monday, Nov. 8, that they are jointly investigating whether the Merck antiviral pill, molnupiravir, approved last week 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 such a trial, according to officials.

 

U.S. drug company, 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 percent. On Thursday, Nov. 4, 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.

 

Barry Zingman, M.D., the principal investigator for the Montefiore-Einstein site, said, “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.”

 

He added, “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, which must be infused into the bloodstream in a clinic or physician’s office.

 

The FDA revised a previous emergency use authorization (EUA) granted to co-administered monoclonal antibodies, bamlanivimab and etesevimab, to include an emergency use “post-exposure prevention” of COVID-19 in adults and pediatric patients ≥12 years of age who are at high risk of progression to severe COVID-19.

 

This basically means that the monoclonal antibodies can be used as a treatment and a preventative form of therapy for vulnerable, high-risk individuals. As above, such individuals would need to go to a hospital or infusion center, however, to receive this form of therapy.

 

On the other hand, although Merck’s molnupiravir pills have not yet been approved in the U.S. for treating or preventing COVID-19, the new antiviral pills could potentially have a bigger impact than the monoclonal antibodies (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 international study will include about 1,300 people at 114 sites globally, with the Montefiore-Einstein site enrolling between 10 and 20 people. A placebo is a substance or treatment which is designed to have no therapeutic value.

 

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.

 

BREAKING: Today we announced the first authorization in the world for our investigational #COVID19 #antiviral treatment, from the United Kingdom’s MHRA. Read more about the news: https://t.co/wvP8pG7b7a $MRK pic.twitter.com/1J3nMZnBvt

— Merck (@Merck) November 4, 2021

 

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 2022.

 

Molnupiravir works through deception — its molecules are absorbed by virus-infected cells and converted into defective RNA “building blocks.” RNA is a molecule similar to DNA. Unlike DNA, RNA is single-stranded. Viral enzymes unwittingly use these defective building blocks to construct the genetic material of newly minted viruses, which then 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.

 

Montefiore-Einstein officials said their site was selected for Merck’s molnupiravir trial due to its diverse patient population and expertise in previous clinical trials of COVID-19 and other infectious diseases, as reported.

 

For example, officials said the international trial carried out at Montefiore-Einstein which started in 2020 of the antiviral medication, Remdesivir, which is administered via injection, as reported, was successful and, in fact, this therapy ended up becoming the first FDA-approved treatment for COVID-19. Montefiore-Eistein had one of the largest numbers of people enrolled in the first Remdesivir trial from across the country, and Remdesivir was FDA approved in October 2020.

 

As reported, it was one of the treatments provided to former President Donald Trump when he contracted COVID-19. As above, Remdesivir and steroids, as also reported, are currently the only FDA-approved treatments to fight COVID-19 but aren’t wholly preventative.

 

On the other hand, the new molnupiravir oral antiviral pill is more straight-forward to administer and it is why Dr. Zingman feels it may be a game-changer when it comes to preventing COVID-19 in unvaccinated vulnerable, at-risk individuals who live with people who may contract the disease.