Metformin, a common, safe and inexpensive drug for type 2 diabetes, lowers the odds of emergency department visits, hospitalizations or death due to COVID-19 by over 40%; and over 50% if prescribed early in onset of symptoms, according to a new multi-site clinical trial led by the University of Minnesota Medical School and School of Public Health. Northwestern University Feinberg School of Medicine was one site in the trial.
The study also found no positive effect from treatment with either ivermectin (an antiparasitic) or low-dose fluvoxamine (an antidepressant).
These findings were a secondary outcome of the trial. The primary outcome included whether someone had low oxygen on a home oxygen monitor, and none of the medications in the trial prevented the primary outcome.
The COVID-OUT clinical trial was the nation's first to study whether metformin, low-dose fluvoxamine and ivermectin-or their combinations-could serve as possible treatments to prevent emergency department visits or hospitalization, as well as long COVID.
The study was published August 17 in the New England Journal of Medicine.
"While the prospect of on-the-fly development of new vaccine technology to help prevent an emerging disease has been instrumental in managing this pandemic, it's also important to assess a variety of potential treatments and re-use agents if safe and shown to have benefit," said co-investigator Dr. David Liebovitz, associate vice chair for clinical informatics in the department of medicine at Feinberg. "In this study, we gained a lot of experience on how to study this relatively quickly, enroll patients remotely to prevent additional spread, better monitor viral load and ship medications out daily."
Northwestern 'stumbled' into trial through bioinformatics
The clinical trial is one of the largest studies to work with study participants completely remotely. In fact, Northwestern essentially "stumbled" into the trial because of Liebovitz's informatics work to examine patients' de-identified electronic medical records.
Liebovitz was using a bioinformatics tool that analyzes population data to perform quality improvement assessments and ensure hospitals were caring for COVID-19 patients "in the best possible way" early in the pandemic.
"Across our systems, we had a good number of COVID-19-positive patients who were already taking metformin for their type 2 diabetes," said Liebovitz, also the co-director of the Center for Medical Education in Data Science & Digital Health at Feinberg. "It looked like there was a hint of a favorable signal with metformin use, and that those patients had fewer hospital stays and were less likely to die on metformin."