The COVID-OUT study has been profiled on TrialSite as one of the largest drug repurposing studies in the United States. Sponsored by the University of Minnesota in partnership with UnitedHealthcare (Optum), recent media entries suggest the clinical investigators close in on the end of the clinical trial testing ivermectin and two other repurposed drugs including fluvoxamine within a month. The study is led by principal investigator Carolyn Bramante, MD, and David Boulware whom TrialSite recently interviewed.
Announcing this study last year, TrialSite reported that in addition to support from UnitedHealthcare’s OptumLabs, a division of one of Americas’ largest health insurers, more support came from the Parsemus Foundation, the Rainwater Charitable Foundation, and Fast Grants.
This study evaluates if existing repurposed therapies can treat COVID-19, including the antidepressant fluvoxamine and the diabetes treatment drug, metformin. However, the study is probably most known for its inclusion of ivermectin, the antiparasitic drug that many people not only in the United States but also in other parts of the world have used off-label to treat COVID-19. To date, ivermectin is only approved in America for antiparasitic use.
Recently covered in the Minneapolis Star Tribune, the study lead Dr. Bramante went on the record that the study results just might offer some parameters for physicians who seek to use highly available, low cost repurposed drugs. Bramante declared, “Sooner would have been better, but I’m really proud of my team. We will be done very quickly.”Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise
This University of Minnesota-led study targeted 1,100 COVID-19 patients for enrollment to be treated with fluvoxamine and ivermectin alone or in combination with metformin, or a placebo option as a comparator.
The patients are given the orally administered drug for 14 days and the hope is that the regimen will help reduce hospitalization rates while helping the patients maintain healthy blood oxygen levels, reports Jeremy Olson from the Star Tribune.
Importantly, over 70 studies from around the world offer some positive data, yet the medical establishment in places like America has been resistant to accept the drug. A comprehensive list of those studies can be found here.
Ivermectin Abroad & Home
TrialSite has reported extensively on the potentially positive contribution the drug has made to fighting COVID-19, such as in Uttar Pradesh, India. In the United States during the summer of 2020, Dr. Jean-Jacques Rajter and his wife Juliana Cepelowicz-Rajter completed a successful real-world case series at Broward County Health. The results of that study, known as ICON, were published in the journal, Chest.
Around the world ivermectin is promoted as a drug to be used during the early onset of the SARS-CoV-2 infection, acknowledged Dr. Bramante in the recent Star Tribune piece.
Overnight Shipping to Patients
When TrialSite interviewed Bramante during the summer of 2021, she reported that University of Minnesota researchers ship the drug to patients at their homes via an overnight shipping depot in a bid to ensure the study drug makes it to those participants with COVID-19 who enroll in less than a day.
Recently, TrialSite interviewed the University of Minnesota’s Dr. David Boulware who oversees COVID-OUT as well as other studies. That interview can be seen on the TrialSite YouTube channel.
Call to Action: For those individuals who become infected with SARS-CoV-2, the virus behind COVID-19, and seek an ivermectin-based study, reach out to the COVID-Out study team to consider participation. Numerous other organizations are participating in this important study including:
- Emory University School of Medicine
- Olive View UCLA Medical Center
- University of Colorado, Anschutz Medical Campus
- Hennepin Health Care
- Northwestern Medicine
- M Health Fairview
For those that want to participate visit the COVID-OUT website.
Carolyn Bramante, MD, MPH
David Boulware, MD, MPH