A new randomized-controlled trial has shown fluvoxamine, an antidepressant, significantly reduces hospitalizations due to COVID-19 (79 [11%] of 741 in the fluvoxamine group .vs. 119 [16%] of 756 in the placebo group).

A low-cost, easy-to-take medication might be the next weapon in the COVID-19 arsenal. According to the largest trial of this FDA-approved generic medicine as a COVID-19 therapy to far, using the antidepressant fluvoxamine within days of developing signs of an infection can drastically reduce the risk of hospitalization and mortality.

Researchers report in the Lancet Global Health on October 27 that a 10-day treatment of the antidepressant fluvoxamine decreased hospitalizations by two-thirds and deaths by 91 percent in newly infected COVID-19 patients at high risk of complications.

Fluvoxamine is a drug used to treat obsessive-compulsive disorder. It works by boosting serotonin levels between nerve cells in the brain. Aside from those effects, child psychiatrist Angela Reiersen of Washington University School of Medicine in St. Louis believes the medicine has other biological qualities that might help to reduce inflammation caused by COVID-19. During her own episode of illness early in the pandemic, she came up with the idea to investigate fluvoxamine as a COVID-19 medication while scouring publications.

"This is an existing medicine with two to three decades of clinical use — something millions of people have taken," says David Boulware, a physicians scientist at the University of Minnesota Medical School in Minneapolis. "It's available at every pharmacy in the U.S., and [a 10-day course] costs $10."

Boulware was not engaged in the most recent trial, but he assisted in the analysis of data from a smaller research that showed fluvoxamine's potential as a COVID-19 therapy early on. That research looked at how the antidepressant was used in the real world by workers who became sick during a COVID-19 epidemic at a California horse racing track in November.

The new study was carried out as part of TOGETHER, a worldwide cooperation that began last year with the goal of testing various repurposed drugs in parallel in placebo-controlled trials. The trial's adaptive design allows researchers to drop medications from the study if statistical analyses demonstrate they are ineffective, as has been the case with the antimalarial medicine hydroxychloroquine and the parasite therapy ivermectin.

Researchers from McMaster University in Hamilton, Canada, collaborated with Cardresearch, a Brazilian research clinic, to recruit 1,497 unvaccinated, high-risk persons in the first week of flu-like symptoms from COVID-19 for the new study. Between January and August, patients at 11 clinical locations across Brazil enrolled in the study and were given either 100 milligrams of fluvoxamine or placebo tablets twice a day for ten days. After therapy, the subjects were followed for another 28 days by the researchers.

Complications requiring hospitalization or more than six hours of emergency treatment occurred in 119 of 756 individuals (15.7 percent) in the placebo group. In comparison, 79 of 741 fluvoxamine-treated individuals (or 10.7%) were ill. The experiment discovered that using fluvoxamine reduced emergency room visits and hospitalization by 32%.

The advantages were much higher among individuals who took at least 80% of their dosages. About three-quarters of patients fell into this category, with gastrointestinal issues being the most prevalent reason for quitting the medication. Fluvoxamine decreased major complications by 66 percent and death by 91 percent in that group. Twelve individuals died in the placebo group, compared to one in the medication group.

Given the most recent research and fluvoxamine's extensive history of safety use, Reiersen says, "we believe it should be used in COVID-19 for patients at high risk for morbidity and mortality from complications of the infection." According to Boulware, the expert council that produces COVID-19 treatment guidelines in the United States was briefed on the findings in mid-September and might make a decision on fluvoxamine as an early therapy as soon as this month.

The study was published in The Lancet, on October 27th, 2021.

Abstract. Recent evidence indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, we aimed to assess the efficacy of fluvoxamine versus placebo in preventing hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to a tertiary hospital due to COVID-19. Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital.

Reis, G., Dos Santos Moreira-Silva, E. A., Silva, D., Thabane, L., Milagres, A. C., Ferreira, T. S., Dos Santos, C., de Souza Campos, V. H., Nogueira, A., de Almeida, A., Callegari, E. D., de Figueiredo Neto, A. D., Savassi, L., Simplicio, M., Ribeiro, L. B., Oliveira, R., Harari, O., Forrest, J. I., Ruton, H., Sprague, S., … TOGETHER investigators (2021). Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial. The Lancet. Global health, S2214-109X(21)00448-4. Advance online publication. https://doi.org/10.1016/S2214-109X(21)00448-4

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