WASHINGTON — It's been a widely-maligned drug, but one of Virginia's top medical research centers is now recruiting patients for a clinical trial to see if ivermectin is safe and effective for the treatment of mild-to-moderate COVID-19.
UVA Health has joined a national study evaluating ivermectin and another "repurposed" medication, fluvoxamine, an anti-anxiety drug that may decrease inflammation.
"[In] the majority of the well-controlled trials that have been recorded, ivermectin [has] not shown much benefit. But on the other hand. . . those trials have reinforced that when a dose is chosen appropriately. . . this is a safe drug to be studied," said Patrick Jackson, the principal investigator for the clinical trial at UVA Health.
Jackson said both ivermectin and fluvoxamine are inexpensive and widely distributed for other purposes, so if they are shown to be safe and effective, he said they could have a "huge global impact."
In an article on its website, the FDA says:
"The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals. Ivermectin has not been shown to be safe or effective for these indications.
"There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin. It is not okay."
UVA says Ivermectin "is not available at UVA Health outside of this trial."
The study is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) led by the National Center for Advancing Translational Sciences.
ACTIV-6, “The Randomized Trial to Evaluate Efficacy of Repurposed Medications,” is a nationwide double-blind study. About 15,000 from across the U.S. will help test a number of different medications. In a double-blind study, neither patients nor researchers know whether the medications they're using are placebo or the actual drug being tested.
People from throughout Virginia and across the U.S. can get more information on how to participate in the trial by visiting activ6study.org or calling 833.385.1880. Volunteers in the trial can participate from home.
According to a news release from UVA Health; "To be eligible, participants must be 30 years old or older, have had a positive COVID-19 test within the past 10 days, and have at least two symptoms of the illness for seven days or less. Symptoms include fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, and/or new loss of sense of taste or smell."
"Participation involves taking the medication and keeping track of symptoms over 90 days through online surveys. Medications are shipped at no cost to participants."
Jackson said he does not think studying the drug will encourage more people to take it in ways that are dangerous.
"I kind of think that horse has already left the barn and that a lot of people have been talking about this drug. And so what I think is important right now is to do a high-quality, gold-standard trial to really answer this question conclusively. And I think studies like (this one) are designed in such a way that if the result is positive, that really will change prescribing practice worldwide. And if the result is negative, I think that really answers the question for us. So I'm hopeful that this puts this question to bed in one way or the other," he said.
Ivermectin has been used to treat both humans and animals to treat some parasitic infections. People in the study will get a calibrated dose designed for humans.
Media and poison control reports suggest a number of people around the country have died after taking massive doses of Ivermectin purchased at farm and veterinary supply stores.
A study just published Friday in the journal JAMA Internal Medicine of almost 500 people 50 and older found Ivermectin did not prevent severe COVID-19 any better than symptom management and close observation by medical professionals.
Doctors can currently treat mild to moderate disease with the new drugs Paxlovid and sotrovimab, but "supplies are limited and it's still important to find potential new treatments," said Jackson.