STOP COVID 2
Trial question
What is the role of fluvoxamine in unvaccinated outpatients with symptomatic COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
62.0% female
38.0% male
N = 547
547 patients (339 female, 208 male).
Inclusion criteria: non-hospitalized, unvaccinated patients with confirmed symptomatic COVID-19 infection.
Key exclusion criteria: oxygen saturation < 92% requiring hospitalization at or prior to the time of the first medication dose; highly unstable medical comorbidity; receipt of medication that could not be co-prescribed with fluvoxamine; known bipolar disorder.
Interventions
N=272 fluvoxamine (50 mg on day 1, 100 mg BID thereafter for 15 days).
N=275 placebo (matching placebo BID for 15 days).
Primary outcome
Clinical deterioration
4.8%
5.5%
5.5 %
4.1 %
2.8 %
1.4 %
0.0 %
Fluvoxamine
Placebo
No significant
difference ↔
No significant difference in clinical deterioration (4.8% vs. 5.5%; ARD -0.68, 95% CI -4.4 to 3).
Secondary outcomes
No significant difference in mean WHO 9-point scale (1.11 points vs. 1.13 points; ARD -0.02, 95% CI -0.11 to 0.07).
Borderline significant increase in ambulatory with activity limitation (1.5% vs. 2.2%).
No significant difference in hospitalization with the need for supplemental oxygen (1.8% vs. 3.3%; RR 0.55, 95% CI -1.44 to 2.54).
Safety outcomes
No significant difference in serious adverse events.
Significant difference in mild-to-moderate gastroesophageal symptoms (8.1% vs. 4.0%).
Conclusion
In non-hospitalized, unvaccinated patients with confirmed symptomatic COVID-19 infection, fluvoxamine was not superior to placebo with respect to clinical deterioration.
Reference
Angela M Reiersen, Caline Mattar, Rachel A Bender Ignacio et al. The STOP COVID 2 Study: Fluvoxamine vs Placebo for Outpatients With Symptomatic COVID-19, a Fully Remote Randomized Controlled Trial. Open Forum Infect Dis. 2023 Aug 8;10(8):ofad419.
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