Fluvoxamine and COVID-19 virus

COVID-OUT Clinical Trial Results Announced

Key findings:

  • Metformin reduced emergency room visits, hospitalization, or death by 42%
  • When taken immediately after symptoms, metformin reduced serious outcomes by over 50%
  • Ivermectin and low-dose fluvoxamine did not improve outcomes of COVID-19
  • COVID-19 has spread around the world causing high mortality and suffering, as well as significant economic impacts.
  • Over 6.4 million people worldwide have died of the virus, with the United States having the highest number of deaths and infections.
  • Vaccines against SARS-CoV-2 have been approved, but they are not available in all locations and some choose not to be vaccinated.
  • Treatments are needed now to reduce the impact of infection.
  • The Parsemus Foundation supported the use of simple, inexpensive therapies for COVID-19 using medications that are already available and proven safe.
  • The foundation supported enrollment efforts for several clinical trials of drugs for COVID-19 treatment, including the COVID-OUT study.

Project Topics

Major COVID-19 treatment study reports results

The University of Minnesota recently completed the COVID-OUT clinical trial: a large rigorous study to understand if common, inexpensive medicines (metformin, fluvoxamine or ivermectin) prevent severe COVID-19 infection and long-COVID symptoms. The initial results were published in the New England Journal of Medicine.

From the university’s press release: “We are pleased to contribute to the body of knowledge around COVID-19 therapies in general, with treatments that are widely available,” said Carolyn Bramante, MD, principal investigator of the study and an assistant professor of internal medicine and pediatrics at the U of M Medical School. “Our trial suggests that metformin may reduce the likelihood of needing to go to the emergency room or be hospitalized for COVID-19.”

The study also reported that reduced-dose fluvoxamine, an antidepressant, and ivermectin, and anti-parasitic, alone or in combination with metformin, did not improve outcomes for individuals infected with COVID. (Click the buttons below for more information on these three different medications.)

Additional facts about the study:

  • 1323 individuals participated in the study.
  • The metformin results were a secondary outcome: the primary outcome included low oxygen, but none of the medications in the trial prevented the primary outcome.
  • Only adults with a BMI (body mass index) greater than or equal to 25kg/m2 were enrolled.
  • Pregnant women were included in the metformin group.
  • The majority of participants were vaccinated, and metformin was effective for both vaccinated and unvaccinated individuals.
  • Fluvoxamine doses were a third to half as much as used in previous studies in an attempt to avoid side effects. This may explain why previous positive results were not found in this study.

Off-label use of medications for COVID-19

Here we review the data on three of these possible therapies for COVID that are part of clinical trials. Click on the buttons for more detailed information on past studies and links to research results.

FAQ on the COVID-OUT Study

Metformin lowers blood sugar and inflammation by activating an enzyme called AMPK. This activity also appears to reduce angiotensin-converting enzyme 2 (or ACE2), which serves as a gateway for COVID-19 to enter and infect cells. Thus, the way metformin works to control blood sugar might also help to control coronavirus infection (see this article in Everyday Health).

A number of inexpensive, safe, existing medications have been studied as possible treatments for COVID infection. With limited profit potential and lack of research funding, it has taken time for the required clinical studies to be completed. 

Visit your doctor to learn about treatment options. You can bring information like that included in this website to discuss metformin with your healthcare provider.

Strong observational and randomized clinical trial data exists to support the use of metformin as a treatment for COVID. It is up to regulatory bodies (such as the U.S. FDA) whether they will officially add metformin to approved COVID treatments.

See Additional Resources below.

Background on repurposing existing medications for treatment of COVID

Most of the scientific research on the virus SARS-CoV-2 has been on developing vaccines for COVID-19. Highly effective vaccines are available in many countries now, but worldwide availability will take time. In addition, some individuals choose not to get vaccinated. 

Proven therapies are needed for those infected with COVID-19. Existing drugs that could be repurposed to fight COVID infection may provide a solution. They are already readily available. Many are inexpensive generics.  

Randomized clinical trials are necessary to determine which existing medications may effectively treat COVID-19 infection. Some trials have recently been completed and others are underway to evaluate the impact of these repurposed drugs on the coronavirus. Funding and enrollment challenges have hampered scientists in completing large randomized, controlled clinical studies. Yet, therapies have the potential to save the lives of hundreds of thousands of people and keep most out of the hospitals. 

Fortunately, these issues have attracted more media attention (see Additional Resources section below), and private funders (like the Parsemus Foundation) have stepped up to complete clinical trials. There is also a call for off-label use of some medications on a case-by-case basis, especially when the risk is very low and the potential benefit to treat COVID is high.

A small foundation’s role in the fight against COVID-19

As a small, agile nonprofit organization, the Parsemus Foundation was able to pivot from our regular funded programs to a new focus on COVID-19 treatment.

The Parsemus Foundation provided direct funding and/or support to three clinical trials: 1) an evaluation of the impact of the MMR (measles, mumps and rubella) vaccine on COVID-19 infection outcomes, 2) two studies evaluating existing, safe medications to individuals who recently tested positive for COVID-19.

Structure of the SARS-CoV-2 coronavirus molecule

Clinical Trials

  • ACTIV-6 National Institutes of Health evaluating existing medications

Scientific publications on repurposed medicines for COVID-19 treatment

 Media resources for COVID-OUT trial

Media coverage of COVID treatment using existing medications

  • Wilson FP. Ivermectin for COVID-19: Final nail in the coffin. Medscapes Oct 31, 2022.
  • Simon A. U of M study finds diabetes medication can lower odds of COVID hospitalization, death. KARE 11 Aug 17, 2022.
  • Sidik SM. The hunt for drugs for mild COVID: scientists seek to treat those at lower risk. Nature Jul 18, 2022.
  • Landhuis E. These are the latest COVID treatments. Scientific American Jan 21, 2022.
  • Avril, T. Another old drug is being tried vs. COVID-19, and might actually help. Philadelphia Inquirer Jan 20, 2022.
  • Putka S. Doctor submits fluvoxamine EUA application to FDA. MedPage Today Dec 29, 2021.
  • Landhuis E. The Challenge and Promise of Getting Oral COVID Drugs Into Practice. Medscape Dec 17, 2021.
  • Landhuis E. Investigating antidepressants’ surprising effect on COVID deaths. Scientific American Nov 12, 2021.
  • Suliman A. Antidepressant drug shows promise in treating covid-19, study finds. Washington Post Oct 28, 2021.
  • Landhuis, E. The antidepressant fluvoxamine can keep COVID-19 patients out of the hospital. Science News Oct 27, 2021.
  • Harris J. Continuing the fight against COVID-19. University of Minnesota Foundation Summer 2021.
  • Landhuis E. Scientists Seek Covid Treatment Answers in Cheap, Older Drugs. California Healthline Mar 26, 2021.
  • Stone S. New COVID-19 treatment trial is first to include pregnant women. ABC Denver Mar 31, 2021.
  • Raddatz K. U Of M Medical School studies whether diabetes drug is effective against COVID. CBS Minnesota Mar 19, 2021.
  • Kabani M. COVID-19 research points to repurposed drugs. 60 Minutes Mar 7, 2021.
  • Snowbeck C. University of Minnesota to expand study of whether common diabetes drug could treat COVID. Star Tribune Mar 2, 2021.
  • Gupta S, Kane A. Everything old is new again: Repurposing drugs to treat Covid-19. CNN Feb 27, 2021.
  • Walters K. MMR vaccine shows some COVID-19 protection. HCPlive Feb 26, 2021.
  • Sukhatme V, Sukhatem V. A call to action: Immediate deployment 0f select repurposed drugs for COVID-19 outpatient treatment. HealthAffairs Feb 9, 2021.
  • McMaster University. New study to test drugs for early COVID-19 infection. EurekAlert Feb 9, 2021.
  • Emanuel E, Bright R, Gounder C, Borio L, Osterholm M, Gawande A. Opinion: Vaccines alone won’t solve the pandemic. Here are 3 other things we must do. Washington Post Feb 5, 2021.
  • Landhuis, E. The antidepressant fluvoxamine could keep mild COVID-19 from worsening. Science News Feb. 1, 2021.
  • Klausner J. Existing drugs could help treat covid-19. How do we know when to use them? Washington Post Jan 27, 2021.
  • Al-Agba N. What if I can’t get the COVID-19 vaccine right now? KitSap Sun Dec 26, 2020.
  • Rapaport L. Metformin linked with lower risk of death from COVID-19 in people with Type 2 diabetes. Everyday Health Jun 9, 2020.
  • Apple S. Un-miracle drugs could help tame the pandemic. WIRED Apr 20, 2020.

Human Health News

We’re sorry, you are not eligible for the nationwide COVID-OUT or ACTIV-6 studies, but you may be eligible for other federal trials:

And if you don’t find a match there, this slightly more complex clinical trials finder includes studies sponsored by companies as well:

Trials Today