Author:
Naggie Susanna,Boulware David R.,Lindsell Christopher J.,Stewart Thomas G.,Lim Stephen C.,Cohen Jonathan,Kavtaradze David,Amon Arch P.,Gabriel Ahab,Gentile Nina,Felker G. Michael,Rothman Russell L.,Jayaweera Dushyantha,McCarthy Matthew W.,Sulkowski Mark,Wilson Sybil,DeLong Allison,Remaly April,Wilder Rhonda,Collins Sean,Dunsmore Sarah E.,Adam Stacey J.,Thicklin Florence,Hanna George J.,Ginde Adit A.,Castro Mario,McTigue Kathleen,Shenkman Elizabeth,Hernandez Adrian F.,
Abstract
AbstractBackgroundWhether ivermectin, with a maximum targeted dose of 600 μg/kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate coronavirus disease 2019 (COVID-19) remains unknown. Our objective was to evaluate the effectiveness of ivermectin, dosed at 600 μg/kg, daily for 6 days compared with placebo for the treatment of early mild to moderate COVID-19.MethodsACTIV-6, an ongoing, decentralized, randomized, double-blind, placebo-controlled, platform trial, was designed to evaluate repurposed therapies in outpatients with mild to moderate COVID-19. A total of 1206 participants age ≥30 years with confirmed COVID-19, experiencing ≥2 symptoms of acute infection for ≤7 days, were enrolled from February 16, 2022, through July 22, 2022, with follow-up data through November 10, 2022, at 93 sites in the US. Participants were randomized to ivermectin, with a maximum targeted dose of 600 μg/kg (n=602), daily vs. placebo daily (n=604) for 6 days. The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms. The 7 secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28.ResultsAmong 1206 randomized participants who received study medication or placebo, median (interquartile range) age was 48 (38–58) years; 713 (59%) were women; and 1008 (84%) reported ≥2 SARS-CoV-2 vaccine doses. Median time to recovery was 11 (11–12) days in the ivermectin group and 11 (11–12) days in the placebo group. The hazard ratio (HR) (95% credible interval [CrI], posterior probability of benefit) for improvement in time to recovery was 1.02 (0.92–1.13; P[HR>1]=0.68). In those receiving ivermectin, 34 (5.7%) were hospitalized, died, or had urgent or emergency care visits compared with 36 (6.0%) receiving placebo (HR 1.0, 0.6– 1.5; P[HR<1]=0.53). In the ivermectin group, 1 participant died and 4 were hospitalized (0.8%); 2 participants (0.3%) were hospitalized in the placebo group and there were no deaths. Adverse events were uncommon in both groups.ConclusionsAmong outpatients with mild to moderate COVID-19, treatment with ivermectin, with a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo did not improve time to recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19.Trial registrationClinicalTrials.govIdentifier:NCT04885530.
Publisher
Cold Spring Harbor Laboratory
Cited by
2 articles.
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