SAN FRANCISCO--(BUSINESS WIRE)--The widely available diabetes drug metformin reduced serious outcomes by more than half if started within 4 days of COVID symptoms in a large, double-blind randomized controlled trial, the University of Minnesota announced today. The results were published Aug. 18 in the New England Journal of Medicine, according to Parsemus Foundation.
Metformin (also known as Glucophage) is most commonly known as a diabetes drug, but also has a little-known past: as an anti-viral treatment in the 1950’s. In more recent research, it also seems to affect mTOR inflammation pathways. Since COVID involves viral inflammation, lead researcher Dr. Carolyn Bramante, Assistant Professor at the University of Minnesota, thought the combination of anti-inflammatory plus antiviral action was important enough to put to the test.
“This was really intriguing to us early on when we learned that people who take metformin were catching COVID less and being hospitalized less,” said Elaine Lissner, founder and trustee of small California nonprofit Parsemus Foundation, which works on low-cost solutions neglected by the pharmaceutical industry. “But you don’t know whether it’s just coincidence until you go back to the beginning, with a rigorous randomized trial.”
“When we learned that researchers at the University of Minnesota were already trying to raise funds to test it, we jumped at the opportunity,” Lissner said. Parsemus Foundation was joined by two larger foundations also eager to see low-cost, globally-accessible medications put to the test.
Three medications – one winner
With philanthropic funds and bilingual outreach, the large COVID-OUT study compared three medications that were considered promising— ivermectin, the object of much interest and passion; a reduced dose of fluvoxamine, an antidepressant that had shown strong results in previous studies; and metformin, an extremely low-cost and widely used diabetes drug. Metformin was the clear winner in the 1323 participants.
Metformin is the most commonly prescribed oral antidiabetic medication worldwide, taken by over 150 million people each year, and is being investigated for anti-cancer properties. It would be the first universally available treatment for early COVID, giving lower-income countries a tool to combat the disproportionate impact on the most disadvantaged.
Controversy over interpretation
In some circles, the results are not being portrayed as a win for metformin. However, that is based on a technicality — that the medication did not help with oxygen levels measured with home monitors. Since the virus has changed and no longer goes straight to the lungs— and home oxygen monitors are now known to have issues with accuracy— that should not be the key takeaway.
Crucially, metformin was the one drug that kept people out of the hospital and reduced deaths.
“You can argue about technicalities — statistics, ad hoc analyses, oxygen monitors — but in the end, half as many people could be ending up in the hospital, and 40% fewer dying, if we get this to high-risk people quickly,” said Lissner. “That was the bottom line. That is not something we can ignore. Are we going to let lives be lost because the virus changed and we can’t adjust to that? Do we think someone is going to run a bigger, better trial of a globally-affordable 100-year-old drug and do better than that? We don’t have the luxury.”
Lessons for the future
“I think there are lessons for all of us in making sure our global clinical trial systems are more robust and ready to jump in on globally critical studies like this in the future,” emphasized Lissner. “It shouldn’t be little foundations like us funding studies of global importance. In the meantime, I hope clinicians around the world take notice: Metformin, an exceedingly inexpensive drug they prescribe every day, if given right away to high-risk people with COVID, can cut poor outcomes—hospitalization, emergency room visits, and death—in half.”
Details about the study results were published online August 18 in the New England Journal of Medicine and can be found in the University of Minnesota’s COVID-OUT study press release: https://med.umn.edu/news-events/covid-out-clinical-trial-suggests-metformin-effective-reducing-odds-serious-outcomes-covid-19-patients-seeking-early-treatment
About the Parsemus Foundation (San Francisco): The Parsemus Foundation works to create meaningful improvements in human and animal health and welfare by advancing innovative and neglected medical research. The foundation’s focus is on supporting proof-of-concept studies and then pursuing press coverage of the results, so that the advances change treatment practice rather than disappearing into the scientific literature. As a small, agile nonprofit organization, the Parsemus Foundation was able to pivot from its regularly funded programs to a new focus on COVID-19 treatment during the pandemic. More information on the Parsemus Foundation and the work presented here can be found at: https://www.parsemus.org/humanhealth/covid-19/