Results from the placebo-controlled trial showed that hospitalizations of COVID-19 patients at high risk for complications were cut by 66% and deaths fell 91%.
"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, of Cardresearch in Brazil, write.
The findings were published online Wednesday in Lancet Global Health.
Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), is an antidepressant commonly prescribed for obsessive-compulsive disorder. About 13% of American adults take some kind of prescription antidepressant, according to the CDC.
Besides its known effects on serotonin – the hormone that affects mood, the drug acts in other ways lower the production of inflammatory cytokines, molecules that immune cells give off. Those alternative mechanisms are the ones believed to help patients with COVID, said co-investigator Angela Reiersen, MD, a child psychiatrist at Washington University School of Medicine in St. Louis.
From Trial to Recommendations
Fluvoxamine cut serious complications in study participants who took at least 80% of their doses. In the placebo group, 12 people died compared with one who received the study drug.
Based on the data, Reiersen said, some experts are recommending fluvoxamine for COVID-19 patients at high risk of death.
However, doctors should note that the drug can cause side effects such as nausea, dizziness, and insomnia, she said. Also, because it prevents the body from processing caffeine, patients should only have half half of a small cup of coffee or one can of soda or one tea while taking the drug.
David Boulware, MD, MPH, an infectious disease doctor-researcher at the University of Minnesota, said fluvoxamine is "a $10 medicine that's available and has a very good safety record."
Boulware was not involved in the study.
Unanswered Safety, Efficacy Questions
In an accompanying editorial, Otavio Berwanger, cardiologist and researcher, from the Hospital Israelita Albert Einstein in Sao Paulo, Brazil, commends the investigators for rapidly generating evidence during the COVID-19 pandemic.
However, despite the important findings, "some questions related to efficacy and safety of fluvoxamine for patients with COVID-19 remain open," Berwanger writes.
The effects of the drug on reducing both death and hospitalizations "still need addressing," he said.
For example, he said, it is unclear if fluvoxamine adds to other existing treatments.
"I believe medical and scientific societies will need to critically appraise the manuscript in order to inform their decisions and recommendations. This interesting trial adds another important piece of information in this regard," he said.