6/28/23, 12:01 AM ACTIV-6 (ivermectin) Pathway Feedback Search Clinical Topics Home Studies ACTIV 6 (ivermectin) ACTIV 6 (ivermectin) Disease COVID 19 infection 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 N = 1591 41.0% male 1591 patients (932 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 g/kg daily for 3 days) N=774 placebo (matching placebo daily for 3 days) Primary outcome Median time to sustained recovery https://web.pathway.md/studies/recAQDRFK2JW7Yb8L 1/2 6/28/23, 12:01 AM ACTIV-6 (ivermectin) Pathway 13.0 days 13 12 9.8 days 6.5 days 3.3 days No significant difference 0.0 days Ivermectin Placebo 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. Open reference URL https://web.pathway.md/studies/recAQDRFK2JW7Yb8L 2/2