A review of fluvoxamine’s ability to prevent hospitalization in COVID-19

Key Messages

This review and meta-analysis examined the evidence for early treatment with fluvoxamine in COVID-19 to reduce hospitalization rate.

Three trials covering 2,196 patients were analyzed. All the patients were unvaccinated, COVID-19 positive (prior to Delta or Omicron) and treated at home with either fluvoxamine or a placebo.

Results indicate that early, at-home treatment with fluvoxamine is associated with reduced risk of hospitalization.

Based on this finding, along with the drug's safety profile, fluvoxamine treatment can safely be recommended for COVID-19 patients.

JAMA Network Open

Publication Date: April 6, 2022
Peer Reviewed: Yes
Publication Type: Review/Commentary/Letter
DOI: https://www.doi.org/10.1001/jamanetworkopen.2022.6269

Fluvoxamine for Outpatient Management of COVID-19 to Prevent Hospitalization: A Systematic Review and Meta-analysis

Todd C. Lee, Simone Vigod, Émilie Bortolussi-Courval, Ryan Hanula, David R. Boulware, Eric J. Lenze, Angela M. Reiersen, Emily G. McDonald


Widely available and affordable options for the outpatient management of COVID-19 are needed, particularly for therapies that prevent hospitalization.

To perform a meta-analysis of the available randomized clinical trial evidence for fluvoxamine in the outpatient management of COVID-19.

Data Sources:
World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov.

Study Selection:
Studies with completed outpatient trials with available results that compared fluvoxamine with placebo were included.

Data Extraction and Synthesis:
The PRISMA 2020 guidelines were followed and study details in terms of inclusion criteria, trial demographics, and the prespecified outcome of all-cause hospitalization were extracted. Risk of bias was assessed by the Cochrane Risk of Bias 2 tool and a bayesian random effects meta-analysis with different estimates of prior probability was conducted: a weakly neutral prior (50% chance of efficacy with 95% CI for risk ratio [RR] between 0.5 and 2.0) and a moderately optimistic prior (85% chance of efficacy). A frequentist random-effects meta-analysis was conducted as a senstivity analysis, and the results were contextualized by estimating the probability of any association (RR ≤ 1) and moderate association (RR ≤ 0.9) with reduced hospitalization.

Main Outcomes and Measures:
All-cause hospitalization.

This systematic review and meta-analysis of 3 randomized clinical trials and included 2196 participants. The RRs for hospitalization were 0.78 (95% CI, 0.58-1.08) for the bayesian weakly neutral prior, 0.73 (95% CI, 0.53-1.01) for the bayesian moderately optimistic prior, and 0.75 (95% CI, 0.58-0.97) for the frequentist analysis. Depending on the scenario, the probability of any association with reduced hospitalization ranged from 94.1% to 98.6%, and the probability of moderate association ranged from 81.6% to 91.8%.

Conclusions and Relevance:
In this systematic review and meta-analysis of data from 3 trials, under a variety of assumptions, fluvoxamine showed a high probability of being associated with reduced hospitalization in outpatients with COVID-19. Ongoing randomized trials are important to evaluate alternative doses, explore the effectiveness in vaccinated patients, and provide further refinement to these estimates. Meanwhile, fluvoxamine could be recommended as a management option, particularly in resource-limited settings or for individuals without access to SARS-CoV-2 monoclonal antibody therapy or direct antivirals.