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The trial included almost 1,500 unvaccinated outpatients in Brazil. All of the patients tested positive for infection with SARS-CoV-2 and were deemed to be at high risk for a severe case of illness.
Fluvoxamine was provided to 741 of the patients while another 756 received a placebo.
Over 28 days of follow-up, the overall rate of hospitalization was 32% lower in the fluvoxamine group than in the placebo group. One patient in the fluvoxamine group died, compared to 12 deaths among those who got the placebo. The study was published online Oct. 27 in The Lancet Global Health.
The fluvoxamine trial was part of the larger TOGETHER trial launched in May 2020 to test potential out-of-hospital COVID-19 treatments. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) medication that has been used since the 1990s for various conditions, including depression and obsessive-compulsive disorder.
Fluvoxamine was chosen because of its anti-inflammatory powers. When COVID-19 strikes, patients' immune systems can create dangerous pro-inflammatory "cytokine storms."
"Fluvoxamine may reduce the production of inflammatory molecules called cytokines, that can be triggered by SARS-CoV-2 infection," study co-author Dr. Angela Reiersen explained in a journal news release. She's associate professor of psychiatry at Washington University in St. Louis.
According to Edward Mills, co-principal investigator for the TOGETHER trial, "Fluvoxamine is, so far, the only treatment that if administered early, can prevent COVID-19 from becoming a life-threatening illness. It could be one of our most powerful weapons against the virus and its effectiveness is one of the most important discoveries we have made since the pandemic began." Mills is a professor in the department of health research methods, evidence and impact at McMaster University in Canada.
"In addition, this cheap, easily accessible pill is a massive boon to public health, both in Canada and internationally, allowing hospitals to avoid expensive and sometimes risky treatments," he added in a university news release.
Fluvoxamine costs just $4 for a 10-day course, so it could be a game-changer for poorer countries that have low vaccination rates and lack more advanced COVID-19 treatments, Mills suggested.
Dr. Eric Ascher is a family medicine physician at Lenox Hill Hospital in New York City. He wasn't involved in the new study, but called the findings "promising."
"The medication potentially decreases the cytokine storm, the process the body undergoes when you suffer from COVID-19, which can cause organ failure," Ascher said. "This is a widely available and accessible medication, and has a low cost associated with its use."
Dr. Theodore Strange, chair of medicine at Staten Island University Hospital, also in New York City, agreed.
"This is an excellent study about an inexpensive, well-tolerated medication, which may have potential to help patients with COVID," Strange said. "The Lancet is an excellent peer-reviewed journal and therefore the TOGETHER trial needs to be further looked into and continued trials here in the USA should be conducted to evaluate the safety and efficacy of this treatment."
In the meantime, the study authors have submitted their findings to the World Health Organization and the U.S. National Institutes of Health.
The U.S. National Institutes of Health has more on fluvoxamine and COVID-19.
SOURCES: Eric Ascher, MD, family medicine physician, Lenox Hill Hospital, New York City; Theodore Strange, MD, chair of medicine, Staten Island University Hospital, New York City; The Lancet Global Health and McMaster University, news releases, Oct. 27, 2021
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