An ongoing COVID-19 clinical trial studying the outpatient use of metformin, a generic medication for type 2 diabetes, has expanded and will now be the nation’s first to include fluvoxamine, an antidepressant, and ivermectin, an antiparasitic, as possible treatment options to prevent hospitalization and “long COVID.”
Led by the University of Minnesota Medical School, the multi-site clinical trial received new support – $1 million from the Rainwater Charitable Foundation and $500,000 from Fast Grants – to expand the study, which is also the first randomized clinical trial for COVID-19 in the world to include pregnant women.
The clinical trial launched after U of M Medical School researchers identified, through computer modeling and observational studies, that outpatient metformin use may decrease the likelihood of dying from or being hospitalized for COVID-19. Their research was published in the Journal of Medical Virology and in The Lancet Healthy Longevity, which was in partnership with UnitedHealth Group’s OptumLabs. These findings, along with other prospective studies supporting the use of fluvoxamine and ivermectin, helped provide enough evidence to expand the randomized clinical trial to include all three medications as well as combination arms.
“Observational studies and test-tube experiments cannot be conclusive but do contribute to bodies of evidence,” said Carolyn Bramante, MD, principal investigator of the study and an assistant professor of internal medicine and pediatrics at the U of M Medical School. “To complete this study, we are currently enrolling volunteers nationwide through six institutions in the U.S., including in Minneapolis.”
The study is simple — patients are randomized to receive 14 days’ worth of either one of the three drugs individually, a placebo or a combination of metformin and fluvoxamine or fluvoxamine and ivermectin to take twice per day and track their symptoms. After 14 days, volunteers complete a survey.
Volunteers for the trial should be between the ages of 30 and 85 years old with a body mass index greater than or equal to 25kg/m2, or someone who is at least five feet and six inches tall and weighs more than 155 pounds. To qualify for the study, volunteers must enroll within three days after receiving a positive COVID-19 test.
“Some new strains of the virus may evade immunity from some of the vaccines. Additionally, worldwide vaccine availability will take time, and not all individuals may get the vaccine. Thus, we feel we should study safe, available, inexpensive outpatient treatment options as soon as possible,” said Bramante, who is also an internist and pediatrician with M Health Fairview. “Having an outpatient treatment option could ensure more people survive the illness if they contract it and have fewer long-term symptoms.”
In addition to the new support from the Rainwater Charitable Foundation and Fast Grants, initial funding and support for the multi-site trial came from the Parsemus Foundation and OptumLabs.
Participating clinical trial sites include M Health Fairview and Hennepin Healthcare in Minneapolis, Northwestern University in Chicago, Olive View – UCLA Education & Research Institute in Los Angeles, Optum in Colorado and Indiana and University of Colorado Denver. Co-investigators on the study include Hrishikesh Belani, MD; Michelle Biros, MD; David Boulware, MD; David Leibovitz, MD; Jacinda Nicklas, MD; David Odde, PhD; Matt Pullen, MD; Mike Puskarich, MD; and Christopher Tignanelli, MD.
To learn more about how to qualify for this study, visit https://covidout.umn.edu/.