ACTIV-6 (fluvoxamine)
Trial question
What is the role of fluvoxamine in outpatients with mild-to-moderate COVID-19 infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
66.0% female
34.0% male
N = 1175
1175 patients (773 female, 402 male).
Inclusion criteria: patients, aged ≥ 30 years, with COVID-19 infection and at least 2 acute symptoms for ≤ 7 days.
Key exclusion criteria: current or recent hospitalization for COVID-19 infection; current or recent use of fluvoxamine or other SSRIs or MAOIs; bipolar disorder; pregnancy or lactation; allergy or contraindication to fluvoxamine.
Interventions
N=601 fluvoxamine (at a dose of 50 mg BID on day 1 followed by 100 mg BID for 12 additional days).
N=607 placebo (matching placebo).
Primary outcome
Time to sustained recovery
10 days
10 days
10.0 days
7.5 days
5.0 days
2.5 days
0.0 days
Fluvoxamine
Placebo
No significant
difference ↔
No significant difference in time to sustained recovery (10 days vs. 10 days; HR 0.99, 95% CI -1.28 to 3.26).
Secondary outcomes
No significant difference in the rate of hospitalization, urgent care, emergency department visit, or death through day 28 (2.38% vs. 3.58%; HR 0.69, 95% CI -6.45 to 7.83).
No significant difference in the rate of hospitalization or death through day 28 (0.17% vs. 0.34%; HR 0.51, 95% CI 0.05 to 5.64).
No significant difference in mean time unwell (11.28 days vs. 11.45 days; AD -0.17 days, 95% CI -1.35 to 1.01).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients, aged ≥ 30 years, with COVID-19 infection and at least 2 acute symptoms for ≤ 7 days, fluvoxamine was not superior to placebo with respect to time to sustained recovery.
Reference
Thomas G Stewart, Paulina A Rebolledo, Ahmad Mourad et al. Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial. JAMA. 2023 Dec 26;330(24):2354-2363.
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