An early trial of fluvoxamine to treat mild coronavirus disease 2019 (COVID-19) showed promising results, suggesting the antidepressant may help ward off clinical deterioration in patients with mild symptoms.
Fluvoxamine, an antidepressant used to treat obsessive-compulsive disorder, may help prevent clinical deterioration of patients with mild coronavirus disease 2019 (COVID-19), results of an early clinical trial suggest.
The double-blind, placebo-controlled, randomized study, published in JAMA, included 152 outpatients with COVID-19 in the St. Louis area between April 10 and August 5. Over 15 days, clinical deterioration was reported in none of the participants who received fluvoxamine and in 6 (8.3%) of those who received a placebo.
“Fluvoxamine prevented clinical deterioration,” lead author Eric Lenze, MD, the Wallace Renard Professor of Psychiatry at Washington University School of Medicine, told Contagion®. “Patients with mild COVID-19 who took it did not progress to more severe disease with shortness of breath and hypoxia. This suggests that fluvoxamine prevents lung injury, which is a hallmark of severe COVID-19.”
An estimated 10 percent of people who initially present with mild symptoms of COVID-19 go on to develop damage to the lungs marked by shortness of breath and decreased oxygen levels. Some studies have suggested inflammation may be the cause of this clinical deterioration in cases that are initially mild.
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that works as a sigma-1 receptor agonist to control inflammation. The study sought to test the hypothesis that fluvoxamine could reduce the cytokine release, but further research is needed to understand the underlying mechanism of the potential treatment for COVID-19.
The study included 80 participants who received 100 mg of fluvoxamine twice a day, increasing to three times a day, and 79 who received a placebo within 7 days of symptom onset. Participants recorded oxygen saturation, vital signs, medication adherence and symptoms twice daily and results were reported via email and phone.
The primary endpoint was clinical deterioration defined as dyspnea or hospitalization for dyspnea or pneumonia and decrease in oxygen saturation to less than 92%.
None of the 80 patients in the fluvoxamine group experienced clinical deterioration, compared with in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% confidence interval, 1.8%-16.4%]).
Adverse events included 1 serious event and 11 other events in the fluvoxamine group and 6 serious events and 12 others in the placebo group.
“Results should be considered preliminary,” Lenze said. “Many doctors will be unfamiliar with fluvoxamine; we have posted what to know about this drug on our website, healthymind.wustl.edu.”
The drug is safe, widely available and inexpensive, the study noted, but may interact with other drugs.
Limitations of the study include its small size, limited geographic area and short duration.
“We have a larger trial starting very soon to confirm these results,” Lenze said. “Once it starts, patients can self-refer through the website, www.stopcovidtrial.com.”
Lenze said he was surprised by how difficult it was to conduct the trial.
“I wish our country was putting more effort into supporting clinical trials for early COVID-19 treatment at the local, state, and federal levels,” he said.
JAMA editors Christopher Seymore, MD, Howard Bauchner, MD, and Robert Golub, MD, wrote in an accompanying editor’s note that the publication has received more than 10000 COVID-19 submissions since February. They said the study is preliminary and shouldn’t be the basis for treatment decisions. But it warranted publishing because of its sound design and the notable features of being a remote, contactless trial of self-quarantined participants.
“The conduct of clinical trials is always difficult, but even more so during a pandemic,” they wrote, noting that the features of this study were worth highlighting.