ACTIV-6 (ivermectin)
Trial question
What is the role of ivermectin in outpatients with mild to moderate symptomatic COVID-19 infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 1591
1591 patients (933 female, 658 male).
Inclusion criteria: patients aged ≥ 30 years with confirmed COVID-19, experiencing ≥ 2 symptoms of acute infection for ≤ 7 days.
Key exclusion criteria: prior diagnosis of COVID-19 infection; current/recent hospitalization; known allergy/hypersensitivity/contraindication to the study drug.
Interventions
N=817 ivermectin (at a dose of 400 mcg/kg daily for 3 days).
N=774 placebo (matching placebo daily for 3 days).
Primary outcome
Median time to sustained recovery
12 days
13 days
13.0 days
9.8 days
6.5 days
3.3 days
0.0 days
Ivermectin
Placebo
No significant
difference ↔
No significant difference in median time to sustained recovery (12 days vs. 13 days; HR 0.93, 95% CI 0.85 to 1.04).
Secondary outcomes
No significant difference in the rate of hospitalization or death by day 28 (1.22% vs. 1.16%; HR 1.1, 95% CI 0.4 to 2.6).
No significant difference in the rate of composite outcome of hospitalization, urgent or emergency care visit, or death by day 28 (3.9% vs. 3.6%; HR 1.2, 95% CI 0.6 to 1.8).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients aged ≥ 30 years with confirmed COVID-19, experiencing ≥ 2 symptoms of acute infection for ≤ 7 days, ivermectin was not superior to placebo with respect to median time to sustained recovery.
Reference
Susanna Naggie, David R Boulware, Christopher J Lindsell et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Oct 25;328(16):1595-1603.
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