The common medication was found to be effective in reducing the odds of serious outcomes for patients with COVID-19

Researchers have found that metformin, a commonly prescribed diabetes drug, reduces the odds of emergency room visits, hospitalizations or death from COVID-19 by more than 40 percent; and more than 50 percent if prescribed early in the onset of symptoms.

The trial compared the effect of ivermectin, fluvoxamine and metformin in a randomized, double-blind, placebo-controlled trial.

Scientists have found that metformin, a commonly prescribed diabetes drug, reduces the odds of emergency room visits, hospitalizations or death from[{” attribute=””>COVID-19 by over 40 percent; and over 50 percent if prescribed early in onset of symptoms. The study, which was published on August 18 in the New England Journal of Medicine, also found no positive effect from treatment with either ivermectin or low-dose fluvoxamine. The research was led by the University of Minnesota Medical School and School of Public Health.

“We are pleased to contribute to the body of knowledge around COVID-19 therapies in general, with treatments that are widely available,” said Carolyn Bramante, MD, principal investigator of the study. Bramante is an assistant professor of internal medicine and pediatrics at the U of M Medical School. “Our trial suggests that metformin may reduce the likelihood of needing to go to the emergency room or be hospitalized for COVID-19.”

Bramante noted that this was a secondary outcome of the trial. The primary outcome included whether someone had low oxygen on a home oxygen monitor. None of the medications in the trial prevented the primary outcome.

The COVID-OUT trial was the nation’s first to study whether metformin, a medication for type 2 diabetes; low-dose fluvoxamine, an antidepressant; and ivermectin, an antiparasitic, or their combinations could serve as possible treatments to prevent emergency department visits or hospitalization, as well as Long-COVID.

Dr. Carolyn Bramante of the University of Minnesota answers questions about COVID OUT. Credit: University of Minnesota School of Medicine

The design of the studio was simple and straightforward. Patients were randomly assigned to receive one of the three drugs individually, placebo, or a combination of metformin and fluvoxamine or metformin and ivermectin. Although the study was placebo-controlled with exactly-matched placebo pills, Dr. Bramante says 83 percent of volunteers received medication supported by existing data because of the six-arm design. Each volunteer received 2 types of pills to keep their treatment assignment hidden, for 3 to 14 days of treatment. Each participant tracked their symptoms and, after 14 days, completed a survey.

The 1,323 trial participants were limited to adults with a body mass index (BMI) of 25 kg/m2 or greater, which qualifies as overweight, for example someone who was at least five feet six inches tall and weighed more. over 155 lbs. To be eligible for the study, participants voluntarily enrolled within three days of receiving a positive COVID-19 test. It was one of the first randomized clinical trials of COVID-19 to include pregnant women.

The study included both those who were vaccinated against COVID-19 and those who were not. This is the first published trial where the majority of participants were vaccinated.

The clinical trial was launched in January 2021 after University of Medicine scientists identified, using computer models and observational studies, that outpatient use of metformin appeared to decrease the likelihood of death from COVID-19 or being hospitalized for COVID-19. Their research, in collaboration with UnitedHealth Group, was published in the Journal of medical virology yen The Lancet Healthy Longevity. Test tube studies also found that metformin inhibited the Covid-19 virus in laboratory settings. These findings, along with additional prospective studies supporting the use of higher doses of fluvoxamine and ivermectin, provided the evidence to include all three medications as well as combination arms.

“Observational studies and in vitro experiments may not be conclusive, but they do contribute to bodies of evidence,” said Bramante, who is also an internist and pediatrician at M Health Fairview. “To complete this study, we enrolled volunteers across the country across six institutions across the United States, including Minneapolis.”

Reference: “Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19” by Carolyn T. Bramante, MD, MPH, Jared D. Huling, Ph.D., Christopher J. Tignanelli, MD, John B. Buse, MD , Ph.D., David M. Liebovitz, MD, Jacinda M. Nicklas, MD, MPH, Kenneth Cohen, MD, Michael A. Puskarich, MD, Hrishikesh K. Belani, MD, MPH, Jennifer L. Proper, BS, Lianne K. Siegel, Ph.D., Nichole R. Klatt, Ph.D., David J. Odde, Ph.D., Darlette G. Luke, Pharm.D., Blake Anderson, MD, Amy B. Karger, MD, Ph.D., Nicholas E. Ingraham, MD, Katrina M. Hartman, BA, Via Rao, MS, Aubrey A. Hagen, BA, Barkha Patel, MS, Sarah L. Fenno, MPH, Nandini Avula, BS, Neha V. Reddy, BS, Spencer M. Erickson, BA, Sarah Lindberg, MPH, Regina Fricton, BA, Samuel Lee, BS, Adnin Zaman, MD, Hanna G. Saveraid, Walker J. Tordsen, BA, Matthew F. Pullen , MD, Michelle Biros, MD, Nancy E. Sherwood, Ph.D., Jennifer L. Thompson, MD, David R. Boulware, MD, MPH, and Thomas A. Murray, Ph.D. for the COVID-OUT Test Team, August 18, 2022, New England Journal of Medicine.
DOI: 10.1056/NEJMoa2201662

Participating clinical trial sites included M Health Fairview and Hennepin Healthcare in Minneapolis,[{” attribute=””>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 Jared Huling, PhD; Thomas Murray, PhD; Hrishikesh Belani, MD; Michelle Biros, MD; David Boulware, MD; David Leibovitz, MD; Jacinda Nicklas, MD; David Odde, PhD; Matt Pullen, MD; Mike Puskarich, MD; John Buse, MD, PhD; Jennifer Thompson, MD; and Christopher Tignanelli, MD.

The trial received monetary support from the Parsemus Foundation, Rainwater Charitable Foundation, Fast Grants, and UnitedHealth Group.

In addition, this research was supported by the National Institutes of Health’s National Center for Advancing Translational Sciences, grants UL1TR002494 and KL2TR002492, and the National Institute of Digestive, Diabetes, and Kidney diseases K23 DK124654. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health’s National Center for Advancing Translational Sciences.

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