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Grand Rounds

RCT Results: Does Fluvoxamine for High-Risk Patients Reduce the Risk of Hospitalization Due to COVID-19?

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BACKGROUND AND PURPOSE: 

  • Reis et al. (Lancet Global Health, 2021) assessed the efficacy of fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), vs placebo in preventing COVID-19-related hospitalization  

METHODS: 

  • Placebo-controlled, randomized, adaptive platform trial 
    • 11 participating cities in Brazil   
  • Participants 
    • Symptomatic adults with confirmed SARS-CoV-2 infection 
    • High-risk: Having a known risk factor for progression to severe disease 
  • Interventions 
    • Fluvoxamine: 100 mg twice daily for 10 days 
    • Placebo 
  • Study design 
    • All trial team, site staff, and patients were masked to treatment allocation 
    • Primary outcome based on intention to treat 
    • Modified intention to treat explored patients receiving at least 24 hours of treatment before a primary outcome event  
    • Per-protocol analysis explored patients with a high-level adherence (>80%) 
    • A Bayesian analytic framework was used to establish the effects along with probability of success of intervention compared with placebo 
  • Primary outcome  
    • A composite endpoint of hospitalization: Either retention in a COVID-19 emergency setting for >6 hours or transfer to tertiary hospital due to COVID-19 
    • Outcome occurred within 28 days of randomization  

RESULTS: 

  • Fluvoxamine: 741 patients | Placebo: 756 patients 
    • Trial was stopped early for superiority 
    • Mean (range) age participants 50 (18 to 102) years | 58% female 
  • The proportion of patients with the primary composite outcome was lower for the fluvoxamine group 
    • Fluvoxamine: 11% 
    • Placebo: 16% 
    • Relative risk (RR) 0.68 (95% Bayesian credible interval [BCI], 0.52 to 0.88) 
    • Probability of superiority: 99.8% 
  • Of the composite primary outcome events, 87% were hospitalizations 
  • Findings for the primary outcome were  
    • Similar for the modified intention-to-treat analysis 
      • RR 0.69 (95% BCI, 0.53 to 0.90) 
    • Larger for the per-protocol analysis 
      • RR 0.34 (95% BCI, 0.21 to 0.54) 
  • Deaths in the primary intention-to-treat analysis 
    • Fluvoxamine: 17 
    • Placebo: 25 
    • OR 0.68 (95% CI, 0.36 to 1.27) 
  • Deaths in the per-protocol population 
    • Fluvoxamine: 1 
    • Placebo: 12 
    • OR 0.09 (95% CI, 0.01 to 0.47) 
  • There were no significant differences in number of adverse events due to treatment among patients in either group 

CONCLUSION: 

  • High-risk outpatients with confirmed COVID-19 had reduced hospitalization needs when treated with fluvoxamine (100 mg twice daily for 10 days) 
  • The mechanism underlying the benefit of this SSRI is unknown but the following hypotheses have been suggested 
    • Fluvoxamine has anti-inflammatory action through activation of the protein S1R that regulates cytokine production  
    • Fluvoxamine has antiplatelet activity 
  • The authors state 

We found a clinically important absolute risk reduction of 5.0%, and 32% RR reduction, on the primary outcome of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19, consequent on the administration of fluvoxamine for 10 days 

Learn More – Primary Sources: 

Effect of early treatment with fluvoxamine on risk of emergency care and hospitalization among patients with COVID-19: the TOGETHER randomized, platform clinical trial 

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Related ObG Topics:

Is Statin Use Associated with Better COVID-19 Hospitalization Outcomes?
RCT Results: Does Apixaban or Aspirin Improve Cardiopulmonary Outcomes in Symptomatic COVID-19 Outpatients?
RCT Results: Therapeutic or Prophylactic Anticoagulation for Hospitalized COVID-19 Patients?

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