COVID-19 research briefs: Small randomized trial finds some benefit with fluvoxamine treatment

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Published: 2020-12-20 © 2020 John Wiley & Sons, Inc.

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Clinical question
Is fluvoxamine a promising treatment for COVID-19?

Bottom line
This small randomized trial finds some benefit with fluvoxamine in the treatment of COVID-19. (LOE = 2b)

Reference
Lenze EJ, Mattar C, Zorumski CF, et al. Fluvoxamine vs placebo and clinical deterioration in outpatients with symptomatic COVID-19: a randomized clinical trial. JAMA. Published online November 12, 2020. doi: 10.1001/jama.2020.22760.

Study design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Setting: Outpatient (any)

Synopsis
Research Brief #74: Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) primarily used to treat obsessive-compulsive disorder. It is also is a strong agonist for the sigma-1 receptor that regulates cytokine production, and a French cohort study found an association between SSRI use and a reduced likelihood of intubation or death. In the current study, 181 outpatients with PCR-confirmed COVID-19 who had been symptomatic for fewer than 7 days were randomized to receive fluvoxamine or placebo in a double-blind manner. Patients who were hospitalized at any time or who had an oxygen saturation at baseline of less than 92% were excluded. Fluvoxamine was given as 50 mg once on day 1, then 100 mg twice daily on days 2 and 3, and increased if tolerated to 100 mg 3 times daily through day 15. The primary outcome was clinical deterioration, defined as the development of dyspnea or the need for hospitalization plus an oxygen saturation of less than 92%, and was available for 84% of participants. This outcome occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (0% vs 8.3%; P = .009; number needed to treat = 12). The secondary outcome was clinical deterioration on a 7-point ordinal scale ranging from none (0 points) through stages of increasing oxygen requirements, to the need for mechanical ventilation, and ultimately death (6 points). Of the 6 patients in the placebo group who deteriorated on this scale, 4 were hospitalized and one required mechanical ventilation, but after 30 days none had died. Based on this one small trial, fluvoxamine is a promising treatment for symptomatic outpatients with COVID-19, but these results require confirmation.

Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA

Copyright © 2020 John Wiley & Sons, Inc.