A new drug being tested in Hampton Roads may prevent unvaccinated people from getting COVID-19

Williamsburg — A Hampton Roads medical practice will recruit a handful of patients for a clinical trial to study a new drug that could stop people from contracting the coronavirus from others in their homes.

The trial aims to protect people who share a household with someone known to have tested positive for COVID-19. Only completely unvaccinated adults are eligible.

Tidewater Physicians Multispecialty Group is one of dozens of locations around the world collecting data for the study of molnupiravir, a new drug developed by Merck and Ridgeback Biotherapeutics.

For COVID-19, the federal government already has approved one antiviral drug — remdesivir — and authorized the use of three antibody therapies that help the immune system kick the virus. But all the drugs have to be given intravenously at hospitals or health care facilities.

Doctors have stressed the need for antiviral medications that patients could take orally at the onset of symptoms to stop the coronavirus from advancing. This class of drugs, which emerged in the 1960s, is used to help with viruses such as herpes, flu and HIV. Several drug makers are testing medications for COVID-19 now.

The Biden administration said early this summer it would buy 1.7 million doses of Merck’s pill for $1.2 billion if it proves to be safe and effective. Preliminary research suggests the drug might reduce the risk of serious illness if used shortly after infection. It did not appear to benefit patients who were already hospitalized with severe disease.

Viruses attach to healthy cells in people’s bodies and multiply. But molnupiravir is designed to cause a virus to make genetic copying mistakes to prevent it from reproducing. Dr. Vijay Subramaniam, the local medical group’s lead investigator, thinks the medication could be helpful in the war against the pandemic.

“It’s a secondary prevention, as you know the best thing would have been a vaccination,” he said. “The real goal is to give you a medicine that helps fight the virus off before it can get a hold of your body.”

Across Virginia, more than 65,000 people have been hospitalized for COVID-19 and nearly 12,000 are suspected to have died from the disease. The numbers are climbing swiftly again as the more aggressive delta variant causes a resurgence.

Merck is paying the medical group and other sites to run the trial, and participants also will be paid. Researchers will be looking at whether people develop COVID-19 infections over the duration of the study and if they have any reactions.

A Williamsburg medical practice will assist in a clinical trial to study an investigational antiviral medication, known as molnupiravir, by drug maker Merck.
- Original Credit: Handout
- Original Source: Merck — A Williamsburg medical practice will assist in a clinical trial to study an investigational antiviral medication, known as molnupiravir, by drug maker Merck. - Original Credit: Handout - Original Source: Merck (HANDOUT)

Half of participants will receive the antiviral drug, which will require taking pills twice a day for five days. The remainder will get a placebo. Neither the patients nor the local medical team will know who got the real drug doses until the study closes.

Anyone 18 or older who shares a home with one or more people who has received a positive COVID-19 diagnosis is eligible. The positive person who lives with them must have at least one COVID-19 symptom and should have tested positive within the past 3-5 days.

The participants, in addition to being unvaccinated, can’t have had COVID-19, nor can they be showing signs of the disease.

Williamsburg pulmonologist Dr. Vijay Subramaniam is principal investigator at Tidewater Physicians Multispecialty Group for a clinical trial of a new antiviral medication that could prevent COVID-19 infection.
- Original Credit: Courtesy of TPMG
- Original Source: Tidewater Physicians Multispecia — Williamsburg pulmonologist Dr. Vijay Subramaniam is principal investigator at Tidewater Physicians Multispecialty Group for a clinical trial of a new antiviral medication that could prevent COVID-19 infection. - Original Credit: Courtesy of TPMG - Original Source: Tidewater Physicians Multispecia (Handout / HANDOUT)

Though over 1,300 people will participate in the trial worldwide, the local practice will enroll only 10 or so patients.

Subramaniam said the treatment could be useful for the unvaccinated. If a child contracted COVID-19 from school, for example, the drug could be a way to protect other family members.

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But Subramaniam said everyone who participates in the study also will be counseled on the benefits of COVID-19 vaccination for future prevention.

“Usually the discussion when someone comes in (with COVID-19) is, ‘What the hell were you thinking not getting vaccinated?’” he said.

This is the second coronavirus-related study for which the medical group has recruited patients. Last year it offered an experimental treatment involving a corticosteroid inhaler commonly used in asthma cases.

For that, they had about 70 people enrolled with mild to moderate cases of COVID-19, some of whom lived a long way from the Peninsula in South Hampton Roads and Northern Virginia. About 60% weren’t patients of the practice.

Subramaniam said he believes the results of the previous study were positive, but the complete data hasn’t been released yet.

For information on the new clinical trial, call 757-707-3503 or email clinicaltrials@tpmgpc.com.

Elisha Sauers, 757-839-4754, elisha.sauers@pilotonline.com