Minneapolis / St. Paul, March 15, 2021 (GLOBE NEWSWIRE) -- A new multi-site clinical trial led by the University of Minnesota Medical School is studying the effectiveness of metformin, a generic medication for type 2 diabetes, in the treatment of COVID-19. It will be 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 in 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.
“Observational studies like this cannot be conclusive but do contribute to growing 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 through six institutions in the U.S., including in Minneapolis.”
The study is simple — patients receive 14 days’ worth of immediate-release metformin or a placebo to take twice per day and track their symptoms. After the 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 need safe, available, inexpensive outpatient treatment options as soon as possible,” said Bramante, who is also an internist and pediatrician with M Health Fairview. “Having a realistic outpatient treatment option will ensure more people survive the illness if they contract it.”
Funding and support for stage one of the multi-site trial comes from the Parsemus Foundation, a private foundation in San Francisco, and OptumLabs.
“I am excited to participate in this study,” said Ken Cohen, MD, FACP, executive director of Translational Research, OptumLabs and co-investigator of the study. “Finding an effective, safe, low-cost medication that could treat COVID-19 worldwide, particularly in countries with low healthcare resources, is a critically important endeavor.”
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; David Boulware, MD; David Leibovitz, MD; Jacinda Nicklas, MD; Mike Puskarich, MD; and Christopher Tignanelli, MD.
In the near future, this clinical trial plans to expand to include the study of two other promising drugs, which has been supported by two additional funding partners. This expansion of the clinical trial is pending both FDA and IRB approval before it can launch.
To learn more about how to qualify for this study, visit https://covidout.com.
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