Leonard Imbula, director of the Healthy Mind Lab at Washington University School of Medicine in St. Louis, holds a vial of fluvoxamine, a psychiatric medication that has been demonstrated to be an effective treatment for persons suffering from COVID-19 in a pair of studies conducted on two continents.

A large study conducted by researchers from the Washington University School of Medicine in St. Louis, as well as from Canada and Brazil, found that the drug fluvoxamine prevents some of the most serious complications of COVID-19, significantly reducing the risk of hospitalization and death. The study was conducted by researchers from the Washington University School of Medicine in St. Louis, as well as from Canada and Brazil.

The findings of the study were published in the journal The Lancet Global Health just a few weeks ago.

In this experiment, which was carried out in Brazil, researchers confirmed the findings of the first trial of fluvoxamine for COVID-19, which was initiated in early 2020 and headed by psychiatrists Eric J. Lenze (MD) and Angela M. Reiersen (MD), both of whom are affiliated with the School of Medicine. The findings of that trial were published in the journal JAMA a year ago. The antidepressant piqued the curiosity of the two due to its anti-inflammatory effects, which attracted their attention. They are also co-authors of a new study that was recently published.

The COVID-19 trial in Brazil tracked approximately 1,500 patients who had recently been diagnosed with the disease. The medicine fluvoxamine (a 100 mg pill twice daily for 10 days) was administered to 741 participants, while the placebo was administered to 756 participants twice daily. The trial was terminated early due to the fact that those who received fluvoxamine had much better outcomes than those who received a placebo.

11 percent of those who received fluvoxamine became ill enough to necessitate a lengthy stay at a COVID-19 emergency facility or to be admitted to a hospital, compared with 16 percent of those who received the placebo.

An even more dramatic result was found in a secondary analysis of participants who took at least 80 percent of their pills: the risk of hospitalization or extended emergency care was reduced by two-thirds, and there was only one death among those taking fluoxamine, compared with 12 deaths in the placebo group, yielding a 91 percent reduction in mortality risk.

Lenze, the Wallace and Lucille Renard Professor of Psychiatry and director of the Healthy Mind Lab at Washington University, said, “Based on this replication of our findings in such a large study, we believe fluvoxamine should be considered as a treatment for patients at high risk for serious illness or death,” “In contrast to other therapies being developed to treat COVID-19, this drug has a long and well-established track record of safety, and doctors may choose to prescribe it off-label for COVID-19 right away,” the researchers write.

While vaccines are extremely effective at preventing serious illness, Lenze noted that many countries have had difficulty vaccinating their citizens, and even those who have received vaccinations may still be at risk for serious COVID-19 symptoms due to underlying medical illness or diminished immunity over time. When used as a first-line treatment for newly diagnosed patients, fluvoxamine appears to be extremely helpful in lowering the severity of the disease.

The fluvoxamine trial was initiated by David H. Perlmutter, MD, executive vice chancellor for medical affairs, and the George and Carol Bauer Dean of Washington University School of Medicine in St. Louis. “As COVID-19 spread rapidly around the globe, there have been many attempts to repurpose existing drugs that might have anti-viral and/or anti-inflammatory effects; fluvoxamine is the only drug in this category that has shown promising efficacy to date,” said Perlmutter. “It is truly remarkable ingenuity on the part of the Drs. Reiersen and Lenze team to have developed the original hypothesis for testing this drug, as well as the rapid deployment methods used for the initial clinical trial. But perhaps most importantly, the results point us in the direction of a safe and inexpensive oral agent that can be used to reduce hospitalizations and save lives.”

Fluvoxamine, in contrast to newer antiviral medicines that have shown promise in the treatment of COVID-19, would not require an emergency use authorization before being made available for prescription. Why? It has already been licensed by the United States Food and Drug Administration for the treatment of the obsessive-compulsion disorder (OCD) and has been prescribed for over three decades to treat OCD, anxiety disorders, and depression among other mental health conditions. It is a member of a class of medications known as selective serotonin reuptake inhibitors (SSRIs) (SSRIs). Fluvoxamine, on the other hand, differs from other SSRIs in that it has high interaction with the sigma-1 receptor, a protein found inside cells that helps regulate the body’s inflammatory response.

‘We believe that this medicine is most likely interacting with the sigma-1 receptor in order to limit the synthesis of inflammatory chemicals in the body,’ Reiersen explained. “When it comes to the treatment of psychiatric illness, this represents an interesting distinction from other SSRIs; however, it appears to be critical to fluvoxamine’s effects in patients with COVID-19.”

This year’s findings are the result of a study known as the TOGETHER Trial. It is a large, adaptive platform trial in which more than 4,000 patients from around the world were randomized into trials evaluating existing drugs for their ability to effectively treat COVID-19. The study was funded by the National Institutes of Health. Fluvoxamine is the first of the prospective medications to be found to be successful in a clinical setting.

According to Lenze, the drug costs roughly $4 for a course of treatment, making it potentially cost-effective in comparison to other, newer COVID-19 medicines. “The method may be particularly beneficial in countries where vaccination rates are still low.”

Dr. Edward J. Mills (Ph.D.), the study’s senior author and a professor of health research techniques, evidence, and effect at McMaster University in Hamilton, Ontario, says it is critical that this medication be made available to those in need as soon as possible. The fluvoxamine treatment, according to Mills, who is also a vice president and senior principal scientist at Cytel, a company that manufactures statistical software and provides analytics for clinical trials, is one of the best tools available to reduce the danger for people infected with COVID-19 all over the world, according to Mills.