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U of M: COVID treatment trial still open to unvaccinated patients, but not for long

Enrollment is nearly complete for a large study of repurposed drugs, including Ivermectin and Fluvoxamine. Here's what you need to know.

MINNEAPOLIS — At a time when some promising pills used to treat COVID-19 are in very high demand, and two monoclonal antibody treatments have been tabled due to their effectiveness against the omicron variant, unvaccinated patients who have been recently diagnosed with COVID-19 still have early treatment options if they are willing to sign up for clinical trials.

The University of Minnesota Medical School still has a few spots open in its COVID-Out trial

"We're looking for volunteers who recently tested positive for COVID - within the last three days - who are adults over age 30," said Dr. David Boulware, who has worked on the COVID-Out Trial for about  year.

More than 1,300 people have logged on to www.covidout.com, and signed up for the trial, which is studying whether three existing drugs can be repurposed to treat COVID-19. Dr. Boulware says about 40% of COVID-Out participants have been vaccinated, but they're currently looking for unvaccinated volunteers to fill the last 20 spots.

"Those who are unvaccinated have a much higher risk of progression of severe disease," Dr. Boulware said. "Especially with omicron, people who are vaccinated and boosted, their risk of deterioration is very, very low. So from a trial purpose, it kind of works against the trial being able to show a difference."

The trial is focused on a few combinations of three different drugs. 


This is a common diabetes drug, that Dr. Boulware says has shown promise in observational data among COVID patients, but not yet in rigorous trials.

"It's a very well established medicine for diabetes," he said. "But there's a lot of interest in other properties that it may have."


This drug has been commonly used to treat depression for 25 years, but its anti-inflammatory properties have also shown to be effective against COVID in two large studies. Dr. Boulware says that patients in those trials saw a 30% reduction in ER visits and hospitalization. 

"That's basically the same effect as Molnupiravir, the new Merck drug," Dr. Boulware said. "Yet this has a 25 year safety track record, is relatively inexpensive - about $5 - and it's available today. I think is one option for physicians and for patients, of an anti-inflammatory medicine that has some proven benefit. Especially if they're not able to get other therapies."


This medication, typically used to treat parasitic worms in humans and livestock, has received a lot of attention...  and criticism. The FDA issued a warning about ivermectin after reports that many people were buying it online without a prescription, in quantities meant for animals. Dr. Boulware says very small studies on ivermectin have not been promising, but he says it's important to conduct a wider trial, while administering it in safe doses.

"With ivermectin, there's still about 60,000 prescriptions per week that are being prescribed around the US," Dr. Boulware said. "So there is a lot of use of this medicine, yet the amount of actual clinical data that supports that there is any clinical benefit is very minimal. I think once there's actually good data, whether there is a benefit or there's not a benefit, I think that will really help inform doctors as well as inform patients."

That's why he's hoping, if you're considering any of these treatments, you sign up here.

"By participating in a research study you can really help society's knowledge on what works best," he said. "The more volunteers that we have that participate in trials like the COVIDout.com trial, the faster we'll have an answer."

Dr. Boulware says the COVID-Out Trial will likely be full by the end of January, with the first results expected about a month later.

For those who miss the deadline, Dr. Boulware says the National Institutes of Health is leading a similar study of the drugs on an even larger scale. The ACTIV-6 trial is also available online and available to those seeking early treatment. Go to www.activ6study.org for more information.

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