University of Minnesota Medical School Analysis Shows Comparison of Fluvoxamine and Ivermectin in a Double-Blind, Placebo-Controlled, Randomized Study.
Metformin, a commonly prescribed diabetes medication, can lower the risk of death, emergency room (ED) visits or hospitalizations from COVID-19 by more than 40% and more than 50% if prescribed early during the onset of symptoms, according to the results of a study published in the New England Journal of Medicine.
Researchers also found that there were no positive effects from treatment with ivermectin or low-dose fluvoxamine.
“We are excited to contribute to the body of knowledge surrounding COVID-19 therapies in general, with treatments that are widely available,” said Carolyn Bramante, MD, an assistant professor of internal medicine and pediatrics at the University of Minnesota Medical. School, in a statement. “Our research suggests that metformin may reduce the chance that you will need to go to the emergency room or be hospitalized for COVID-19.”
This was the secondary outcome of the trial, Bramante said.
The primary outcome measure was whether a person had low oxygen levels on a home oxygen monitor, but none of the drugs in the trial prevented this result.
The COVID-OUT study was the country’s first study on whether metformin, low-dose fluvoxamine, ivermectin, or their combinations could serve as potential treatments to prevent emergency room visits, hospitalization and long-term COVID.
Subjects in the study were randomly assigned to receive either 1 of 3 drugs, a placebo, or a combination of metformin and either fluvoxamine or ivermectin. Each individual was given 2 kinds of pills for 3 to 14 days of treatment. They followed their symptoms and completed a survey after 14 days.
There were 1323 subjects in the study and their body mass index was at least 25 kg/m2 or more. To be eligible for the study, subjects enrolled within 3 days of receiving a positive COVID-19 test and included women who were pregnant.
The majority of subjects in the study were vaccinated.
“While we know that COVID-19 vaccines are highly effective, we know that some new virus strains can evade immunity and vaccines may not be available worldwide. So we felt we needed to study safe, available and low-cost outpatient treatment options as soon as possible,” Bramante said in the statement.
“Understanding whether outpatient treatments can help more people survive the disease if they contract it and have fewer long-lasting symptoms is an important part of the pandemic response,” she said.
The trial started in January 2021 after the researchers used computer modeling and observational studies to determine that outpatient use of metformin appeared to reduce death or hospitalization from COVID-19. Results of test-tube studies also showed that metformin inhibited the COVID-19 virus in laboratory settings. These findings, along with other prospective studies supporting the use of higher doses of fluvoxamine and ivermectin, provided evidence to include all 3 drugs, as well as the combination arm.
These findings were published in the Journal of Medical Virology and in The Lancet Healthy Longevity.
The in vitro and observational studies are inconclusive, but add to the evidence, Bramante said.
Researchers also enrolled individuals nationwide through 6 institutions in the United States, including Minneapolis, Minnesota, to complete the study.
COVID OUT clinical trial suggests that metformin is effective in reducing the likelihood of serious outcomes for COVID-19 patients seeking early treatment. news item. EurekAlert. August 18, 2022. Accessed August 18, 2022. https://www.eurekalert.org/news-releases/962177