Researchers from Washington University School of Medicine in St. Louis and from Canada and Brazil have found that the drug fluvoxamine prevents some of the most serious complications of COVID-19, sharply reducing the risk of hospitalization and death.
The study’s results were published in The Lancet Global Health.
This trial, conducted in Brazil, confirms results from the first trial of fluvoxamine for COVID-19, which was launched in early 2020 and led by Eric J. Lenze, MD, and Angela M. Reiersen, MD, both psychiatrists at the WUSTL School of Medicine. Results of that trial were published in JAMA one year ago
The Brazilian study followed about 1,500 patients newly diagnosed with COVID-19. Of them, 741 people received the drug — a 100 mg tablet of fluvoxamine twice a day for 10 days — while 756 received a placebo twice daily. The trial was halted early because those taking the fluvoxamine experienced far better outcomes than those taking a placebo.
Of those taking fluvoxamine, 11% became sick enough to require an extended stay at a COVID-19 emergency facility or be admitted to a hospital, compared with 16% of people who received a placebo.
In a secondary analysis of participants who took at least 80% of their pills, the findings were even more striking: Risk of hospitalization or extended emergency care was reduced by two-thirds, and there was one death among those taking fluoxamine compared with 12 deaths in the placebo group, a reduction in mortality risk of 91%.
Unlike newer antiviral drugs that are reportedly promising against COVID-19, fluvoxamine would not require emergency use authorization before it could be prescribed. That’s because it already is approved by the U.S. Food and Drug Administration (FDA) for treatment of obsessive-compulsive disorder (OCD) and has been prescribed for more than three decades to treat OCD, anxiety disorders and depression. It belongs to a class of drugs known as selective serotonin-reuptake inhibitors (SSRIs). But unlike other SSRIs, fluvoxamine interacts strongly with the sigma-1 receptor, a protein inside cells that helps regulate the body’s inflammatory response.
The new findings come from a study known as the TOGETHER Trial — a large, adaptive platform trial that has randomized more than 4,000 patients worldwide into trials evaluating existing drugs for their ability to effectively treat COVID-19. Fluvoxamine is the first one of the potential treatments to be found effective.
