By Esther Landhuis

The antidepressant fluvoxamine (Luvox) may prevent hospitalization and death in outpatients with COVID-19, new research suggests.

Results from the placebo-controlled, multisite, phase 3 TOGETHER trial showed that in COVID-19 outpatients at high risk for complications, hospitalizations were cut by 66% and deaths were reduced by 91% in those who tolerated fluvoxamine.

“Our trial has found that fluvoxamine, an inexpensive existing drug, reduces the need for advanced disease care in this high-risk population,” the investigators, led by Gilmar Reis, MD, PhD, Research Division, Cardresearch, Belo Horizonte, Brazil, write.

The findings were published online October 27 in Lancet Global Health. As reported by Medscape Medical News in August, the data were originally published as a preprint.

Alternative Mechanisms

Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), is an antidepressant commonly prescribed for obsessive-compulsive disorder.

Besides its known effects on serotonin, the drug acts in other molecular pathways to dampen the production of inflammatory cytokines. Those alternative mechanisms are the ones believed to help patients with COVID, said co-investigator Angela Reiersen, MD, child psychiatrist at Washington University School of Medicine, St. Louis, Missouri.

Based on cell culture and mouse studies showing effects of the molecule’s binding to the sigma-1 receptor in the endoplasmic reticulum, Reiersen came up with the idea of testing if fluvoxamine could keep COVID-19 from progressing in newly infected patients.

Reiersen and colleague psychiatrist Eric Lenze, MD, also from Washington Univ., led the phase 2 trial that initially suggested fluvoxamine’s promise as an outpatient medication. They are also co-investigators on the new phase 3 adaptive platform trial called TOGETHER, which was conducted by an international team of investigators in Brazil, Canada, and the United States.

For this latest study, researchers at McMaster University in Ontario, Canada, partnered with the research clinic Cardresearch in Brazil to recruit unvaccinated, high-risk adults within 7 days of developing flu-like symptoms from COVID-19. They analyzed 1497 newly symptomatic COVID-19 patients at 11 clinical sites in Brazil.

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