In the largest study yet to evaluate a common, low-cost antidepressant as a treatment for COVID-19, 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 trial, conducted in Brazil, confirms results from the first trial of fluvoxamine for COVID-19, which was launched in early 2020 at Washington University School of Medicine in St. Louis.

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.

Of those taking fluvoxamine, 11 percent became sick enough to require an extended stay at a COVID-19 emergency facility or be admitted to a hospital, compared with 16 percent of people who received a placebo.

In a secondary analysis of participants who took at least 80 percent 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 percent.

"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," said Eric Lenze, a professor of psychiatry and director of the Healthy Mind Lab at Washington University. "Unlike other therapies being developed to treat COVID-19, this drug has a long and well-established record of safety, and doctors could choose to prescribe it off-label for COVID-19 immediately."

Lenze said Fluvoxamine provides a low-cost treatment option for newly diagnosed patients. Unlike newer antiviral drugs that are reportedly promising against COVID-19, fluvoxamine would not require emergency use authorization before it could be prescribed. "And it costs about 4 dollars for a course of treatment, so it also can be cost-effective, unlike other, newer COVID-19 therapies," Lenze said. "It may be particularly useful in countries where vaccination rates remain low."

The results of the study, posted on the university's website on Tuesday, have been published in the journal The Lancet Global Health.

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