COVID-OUT (fluvoxamine)
Trial question
What is the role of fluvoxamine in patients with COVID-19 infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 661
661 patients (358 female, 303 male).
Inclusion criteria: nonhospitalized adult patients aged 30-85 years with a confirmed diagnosis of COVID-19 within the past 3 days.
Key exclusion criteria: hospitalization for COVID-19 infection or other reasons; symptom onset > 7 days; immunocompromised patient; hepatic impairment; alcohol use disorder; history of severe kidney disease.
Interventions
N=334 fluvoxamine (fluvoxamine alone at a dose of 50 mg BID for 14 days or fluvoxamine in combination with metformin).
N=327 placebo (matching placebo or metformin alone).
Primary outcome
Composite outcome of hypoxemia, emergency department visit, hospitalization, or death
24%
24.9%
24.9 %
18.7 %
12.4 %
6.2 %
0.0 %
Fluvoxamine
Placebo
No significant
difference ↔
No significant difference in composite outcome of hypoxemia, emergency department visit, hospitalization, or death (24% vs. 24.9%; OR 0.94, 95% CI 0.66 to 1.36).
Secondary outcomes
No significant difference in composite outcome of emergency department visit, hospitalization, or death (5.5% vs. 4.6%).
No significant difference in hospitalization or death (1.8% vs. 1.5%; OR 1.11, 95% CI 0.33 to 3.76).
No significant difference in hypoxemia (21.6% vs. 22.8%; OR 0.93, 95% CI 0.64 to 1.35).
Conclusion
In nonhospitalized adult patients aged 30-85 years with a confirmed diagnosis of COVID-19 within the past 3 days, fluvoxamine was not superior to placebo with respect to the composite outcome of hypoxemia, emergency department visit, hospitalization, or death.
Reference
Carolyn T Bramante, Jared D Huling, Christopher J Tignanelli et al. Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19. N Engl J Med. 2022 Aug 18;387(7):599-610.
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