BREAKING! Metformin Might Emerge As Another COVID-19 Drug Candidate With University of Minnesota Now Receiving Funding For Further Research
: A few past research studies the last few months has shown the possibility of using metformin, the common cheap and easily available diabetes drug being used for COVID-19 treatments as it was found to reduce severity and mortality rates in COVID-19 patients.
In one study, the researchers found that among more than 600 patients with diabetes and COVID-19, use of metformin was associated with a nearly 70% reduction in mortality after adjustment for multiple confounders. https://www.medrxiv.org/content/10.1101/2020.07.29.20164020v1
Research data from four previous studies that also show a reduction in mortality among metformin users compared to nonusers were summarized in a "mini review" by Dr André J. Scheen, MD, PhD, published
August 1 in Diabetes and Metabolism
Despite the promising results, further research and randomized trials were stalled as a result of lack of funding due to concerted efforts and lobbying of large pharma companies who are against cheap generic drugs, supplements or herbs as it affects their business models.
However it was now announced that the University of Minnesota Medical School researchers have managed to receive funding from the Parsemus Foundation to initiate further research of metformin for prevention and treatment for COVID-19.
In order to prevent delay during the COVID-19 pandemic, the California-based Parsemus Foundation is funding the University of Minnesota's investigational new drug (IND) application to the Food and Drug Administration (FDA) to launch a multi-center randomized controlled clinical trial of the use of metformin as a COVID-19 treatment and prevention method. https://clinicaltrials.gov/ct2/show/NCT04510194
The research team from University Of Minnesota Medical School, led by co-principal investigators Dr Carolyn Bramante, MD, MPH, in the Department of Medicine, and Dr Christopher Tignanelli, MD in the Department of Surgery, submitted the IND application on August 12. The team has the next few weeks to secure additional funding.
To date the epidemiological data from multiple studies globally support a trend or effect of metformin in preventing hospitalization and death from COVID-19.
Interestingly a mechanism of action in metformin little-known past as an antiviral has yet to be further studied besides its blood sugar reduction and inflammation-reducing effects which are already known. TNFα and mTOR are among the proposed pathways. But, a randomized clinical trial is needed to be sure the association is truly cause and effect
Dr Bramante told Thailand Medical News, "Several observational studies in the U.S. and around the world have shown an association between outpatient metformin use and reduced mortality and hospitalizations for COVID-19." https://www.medrxiv.org/content/10.1101/2020.06.19.20135095v2
She added, "The most recent papers (one not yet publicly available), were done in detailed databases that allowed accounting for body mass index and degree of glucose in the body (hemoglobin A1C). There are known mechanisms of metformin that would reduce severity of COVID-19, including its inflammation reducing effects, and potentially also its ability to inhibit mTOR, a protein that helps the virus grow."
The drug Metformin, familiar to many by the brand names Fortamet or Glucophage, is used as a diabetes medication to lower glucose levels, with a common side benefit of reduced appetite and weight loss.
Research findings from previous studies provided Bramante's team with a reason to believe that metformin is a promising treatment and prevention method for COVID-19, including preliminary data from an observational study co-led by Dr Bramante and Dr Tignanelli.
The study team examined de-identified data from UnitedHealthcare and found that women already taking metformin who were diagnosed with COVID-19 had about 25% reduced risk of mortality.
Preliminary data from another observational study of patients with non-alcoholic fatty liver disease, co-led by Dr Bramante and Dr Tignanelli, showed that treatment for metabolic disease, including taking metformin, was associated with a lower likelihood of being hospitalized due to COVID-19. The findings align with results from observational studies in China and France and from the University of Alabama.
Subject to approval of the IND application, the goal of the clinical trial will be two-fold: to definitively study whether or not metformin prevents SARS-CoV-2 infection and whether or not it can prevent severe COVID-19 disease and hospitalization in those who are infected. The unique study they have designed will also elucidate what duration of metformin is needed to achieve those benefits.
As metformin is already widely used and available, its use to fight COVID-19 could begin as soon as there are positive clinical results and would change the global standard of care for prevention and early-stage disease, similar to recent definitive results on dexamethasone for advanced disease.
The American CDC forecasts predict 1,300 to 5,500 new COVID-19 hospitalizations per day by Oct. 12 in the U.S. alone
. This means that a treatment that reduces hospitalization by about 50-60%, as evidenced by observational data, could potentially prevent thousands of hospitalizations each day in America.
With metformin generics available for less than US$3 per month from manufacturers around the globe, metformin also has the advantage that it can be used immediately and inexpensively worldwide. Metformin is also safe in everyone (children, pregnant women, adults of any age), as long as they don't have significant kidney, liver or heart failure.
Other relevant studies on metformin and COVID-19:
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