ivermectin effective in outpatients with mild to moderate COVID-19

The effectiveness of ivermectin to shorten symptom duration or prevent hospitalization among outpatients in the US with mild to moderate symptomatic COVID-19 is unknown. A study was conducted to evaluate the efficacy of ivermectin, 400 μg/kg, daily for 3 days compared with placebo for the treatment of early mild to moderate COVID-19.

ACTIV-6, an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial, was designed to evaluate repurposed therapies in outpatients with mild to moderate COVID-19. A total of 1591 participants aged 30 years and older with confirmed COVID-19, experiencing 2 or more symptoms of acute infection for 7 days or less, were enrolled from June 23, 2021, through February 4, 2022, with follow-up data through May 31, 2022, at 93 sites in the US.

Participants were randomized to receive ivermectin, 400 μg/kg (n = 817), daily for 3 days or placebo (n = 774). Time to sustained recovery, defined as at least 3 consecutive days without symptoms were main outcomes. There were 7 secondary outcomes, including a composite of hospitalization or death by day 28.

Results:

• Among 1800 participants who were randomized 1591 completed the trial. The hazard ratio (HR) for improvement in time to recovery was 1.07
• The median time to recovery was 12 days in the ivermectin group and 13 days in the placebo group. There were 10 hospitalizations or deaths in the ivermectin group and 9 in the placebo group
• The most common serious adverse events were COVID-19 pneumonia and venous thromboembolism

Among outpatients with mild to moderate COVID-19, treatment with ivermectin, compared with placebo, did not significantly improve time to recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19.

Reference:

Naggie S, Boulware DR, Lindsell CJ, 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. Published online October 21, 2022. doi:10.1001/jama.2022.18590

Keywords:

Naggie S, Boulware DR, Lindsell CJ, Effect, Ivermectin, Placebo, Time, Sustained, Recovery, Outpatients, Mild, Moderate, COVID-19, Randomized, Clinical Trial, JAMA