COVID-OUT (ivermectin)
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
45.0% male
N = 808
808 patients (442 female, 366 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=410 ivermectin (ivermectin alone at a dose of 390-470 mcg/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%
24.6%
25.8 %
19.4 %
12.9 %
6.5 %
0.0 %
Ivermectin
Placebo
No significant
difference ↔
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 adult patients aged 30-85 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.
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