SAN FRANCISCO--(BUSINESS WIRE)--The widely available diabetes drug metformin reduced serious COVID outcomes by more than half if started within 4 days of symptoms, in a large, double-blind, randomized, controlled trial conducted by the University of Minnesota and published Aug. 18 in the New England Journal of Medicine, according to the Parsemus Foundation.
The multi-site COVID-OUT study compared three medications that have been considered promising—low-dose fluvoxamine, an antidepressant; ivermectin, an antiparasitic drug; and metformin, a low-cost diabetes drug. Only metformin produced statistically significant results. Metformin reduced severe outcomes (hospitalization, emergency room visits, and death) by 42% – or 55% if started within 4 days of symptoms.
The study included 1,323 individuals over 30 years old at elevated risk of severe outcomes. It was among the first randomized clinical trials for COVID-19 that included pregnant women and the first published trial that had a majority of vaccinated participants.
These metformin results compare favorably with other approved COVID treatments. For example, a recent analysis of Paxlovid in 721 vaccinated individuals indicated a reduction of hospitalization or death of 57%.
The option to use metformin to treat COVID-19 is a game-changer thanks to its low cost, wide availability, and long history of safe use. Paxlovid is not available to many patients in low-income countries, making metformin potentially their only effective option.
“Although we know COVID-19 vaccines are highly effective, we know that some new strains of the virus may evade immunity and vaccines may not be available worldwide. So we felt we should study safe, available and inexpensive outpatient treatment options as soon as possible,” said Carolyn Bramante, MD, principal investigator of the study and an assistant professor of internal medicine and pediatrics at the University of Minnesota Medical School.
The primary outcome studied included whether someone had low oxygen on a home oxygen monitor, and none of the medications in the trial prevented the primary outcome. The encouraging findings regarding metformin were a secondary outcome. Unfortunately, the distinction between primary and secondary outcomes has led to some contradictory interpretations and commentary. The Parsemus Foundation is working to ensure that the good metformin results are not overlooked.
“We don’t have the luxury of ignoring these results,” commented Elaine Lissner, founder and trustee of the Parsemus Foundation, a small California nonprofit that works on low-cost solutions neglected by the pharmaceutical industry. “This would be the first universally available treatment for COVID, giving lower-income countries a tool to combat the disproportionate impact of this disease.”
For more information see: https://www.parsemus.org/humanhealth/covid-19/