6/28/23, 12:20 AM COVID-OUT (ivermectin) Pathway Feedback Search Clinical Topics Home Studies COVID OUT (ivermectin) COVID OUT (ivermectin) Disease COVID 19 infection Trial question What is the role of ivermectin in patients with COVID-19 infection? Study design Multi-center Double blinded RCT Population Characteristics of study participants 55.0% female N = 808 45.0% male 808 patients (442 female, 366 male) Inclusion criteria: nonhospitalized adults aged between 30 to 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; AUD; history of severe kidney disease Interventions N=410 ivermectin (ivermectin alone at a dose of 390-470 g/kg/day for 3 days or ivermectin in combination with metformin) N=398 placebo (matching placebo or metformin alone) Primary outcome Composite outcome of hypoxemia, emergency department visit, hospitalization, or death 25.8 25 8 % 24 6 https://web.pathway.md/studies/rec7MDosqVHrjjcYY 1/2 6/28/23, 12:20 AM 25.8 % COVID-OUT (ivermectin) Pathway 24.6 19.4 % 12.9 % 6.5 % No significant difference 0.0 % Ivermectin Placebo No significant difference in composite outcome of hypoxemia, emergency department visit, hospitalization, or death (25.8% vs. 24.6%; aOR 1.05, 95% CI 0.76 to 1.45) Secondary outcomes No significant difference in composite outcome of emergency department visit, hospitalization, or death (5.7% vs. 4.1%; aOR 1.39, 95% CI 0.72 to 2.69) No significant difference in hospitalization or death (1% vs. 1.3%; aOR 0.73, 95% CI 0.19 to 2.77) No significant difference in hypoxemia (23.6% vs. 22.6%; aOR 1.04, 95% CI 0.75 to 1.46) Conclusion In nonhospitalized adults aged between 30 to 85 years with a confirmed diagnosis of COVID-19 within the past 3 days, ivermectin 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. Open reference URL https://web.pathway.md/studies/rec7MDosqVHrjjcYY 2/2