Female doctor giving medicine

Common medicine found to be effective in reducing chances of severe outcomes for COVID-19 patients

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

The trial compared the effects 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 chance of emergency department visits, hospitalizations or death.

Coronavirus disease
First identified in Wuhan, China in 2019, coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It has spread globally, causing the 2019-20 coronavirus pandemic.

“data-gt-translation-attributes=”[{” 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.Image credit: University of Minnesota School of Medicine

The study design was straightforward. Patients were randomly assigned to receive one of three drugs, 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 said that because of the six-arm design, 83 percent of the volunteers received the drug supported by the available data. Each volunteer received 2 pills to hide their treatment assignments for 3 to 14 days. Each participant tracked their symptoms, and after 14 days, they completed a survey.

The trial’s 1,323 participants were limited to adults with a body mass index (BMI) greater than or equal to 25 kg/m2, which qualifies as overweight—for example, someone who is at least 5 feet 6 inches tall and weighs more than 155 pounds. To be eligible for the study, participants volunteered within three days of testing positive for COVID-19. This is one of the first randomized clinical trials for COVID-19 to include pregnant women.

The study included people who were vaccinated against COVID-19 and people who were not vaccinated. This is the first published trial in which most participants were vaccinated.

The clinical trial launched in January 2021 after scientists at the University of Michigan School of Medicine found through computer modeling and observational studies that outpatient metformin use appeared to reduce the likelihood of death or hospitalization from COVID-19.Their research in collaboration with UnitedHealth Group was published in Journal of Medical Virology and in Lancet health and longevity. Test-tube studies also found that metformin inhibited the Covid-19 virus in a laboratory setting. These findings, along with other prospective studies supporting the use of high-dose fluvoxamine and ivermectin, provide evidence that includes all three drugs as well as combinations.

“Observational studies and in vitro experiments don’t draw conclusions, but they do help provide evidence,” said Bramante, who is also a physician and pediatrician at M Health Fairview. “To complete this study, we recruited volunteers nationwide through six institutions in the United States, including Minneapolis.”

Reference: “A randomized trial of metformin, ivermectin, and fluvoxamine in the treatment of Covid-19,” by Carolyn T. Bramante, MD, MPH, Jared D. Huling, Ph.D., Christopher J. Tignanelli, MD , John BB Buse, MD, PhD, 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 COVID- OUT Trial Team, August 18, 2022 New England Journal of Medicine.
DOI: 10.1056/NEJMoa2201662

Participating clinical trial sites include M Health Fairview and Hennepin Healthcare in Minneapolis,

Northwest University
Founded in 1851, Northwestern University (NU) is a private research university located in Evanston, Illinois, United States. Northwestern University is known for its McCormick School of Engineering and Applied Sciences, Kellogg School of Management, Feinberg School of Medicine, Pritzker School of Law, Bienen School of Music, and Medill School of Journalism.

“data-gt-translation-attributes=”[{” 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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