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UVa Health leads statewide COVID-19 clinical trial

The University of Virginia Health division wants to know if medicine cabinet drugs can thwart the symptoms of COVID-19.

Called ACTIV-6, the clinical trial is in its fifth arm of testing accessible and affordable medications, both over-the-counter and by-prescription, that have already been approved by the Food and Drug Administration to determine which ones will help positive COVID-19 patients feel better faster.

A national trial has at least one hub for testing and recruiting participants in all 50 states. In Virginia, that hub is UVa.

Dr. Patrick Jackson, an assistant professor who also provides treatment, counseling and education for patients with HIV and AIDS in UVa’s Ryan White HIV Clinic, is the principal investigator.

“This has been a major hole in our ability to treat COVID-19,” Jackson said. “We have drugs that help people in the hospital, we have drugs that keep people out of the hospital, but so far no [drugs] found to improve symptoms, especially for people who are not at a particularly high risk of having a bad outcome.”

“The ACTIV-6 trials looking for a drug that does that. Specifically, the trial is looking at repurposing existing drugs, drugs that are already FDA approved for other indications,” Jackson said. “Generally, [they’re] drugs that are widely available and pretty cheap. We are reaching out to folks in the community who may have a COVID-19 diagnosis, letting them know about the trial.”

The trial is open to people who are at least 30 years old and have tested positive for the disease in the last seven days. Although this trial is not for those who have been hospitalized as a result of COVID-19, researchers hope the results will help prevent hospitalization for those with positive tests.

Since launching the trial last year, ACTIV- 6 has enrolled more than 15,000 participants to test four over-the-counter medications. Researchers found that low doses of the inhaled steroid fluticasone, anti-depressant fluvoxamine and both high and low animal de-wormer ivermectin have no benefit to treating COVID-19 symptoms.

Now, researchers are testing the effectiveness of high doses of fluvoxamine to determine potential benefits, which could include reducing inflammation caused by the disease, for the fifth arm of the trial.

The anti-viral medication Paxlovid, manufactured by Pfizer, has been the most common medication used to treat symptoms of COVID-19 for those affected in the United States. The drug, however, is not so easy to obtain overseas.

Earlier this year, the Biden administration purchased 20 million treatment units of Paxlovid, which has helped keep the drug affordable and accessible. But for those living in developing countries, it is unlikely that people will be able to buy Paxlovid at their local stores.

Discovering common and familiar medications that successfully treat Covid symptoms could have a huge impact in other countries, Jackson says.

“Patients with mild to moderate COVID-19 in the developing world have very little to help [treat symptoms], even if they are high risk folks that would be treated in the United States with a drug like Paxlovid,” Jackson said. “If one of these repurposed drugs has a benefit for COVID-19, then that really could be a game changer for people in the rest of the world.”

Duke University researchers are the principle investigators in the trial, having launched the national effort from their North Carolina labs last year.

“A year ago, the biggest worry was people going into hospital or dying. We see very low rates of that, but we still see people who have ongoing symptoms or ongoing functional limitations,” said Adrian Hernandez, vice dean and executive director of Duke Clinical Research.

Jackson is expecting the trial to roll out new arms with new repurposed drugs to test in the coming weeks.

Eligible Virginia residents can read more information and enroll in the 90-day trial on the ACTIV-6 website.

Source: www.dailyprogress.com

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