Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial

{ 'indexed': {'date-parts': [[2024, 4, 8]], 'date-time': '2024-04-08T20:34:38Z', 'timestamp': 1712608478563}, 'reference-count': 15, 'publisher': 'American Medical Association (AMA)', 'issue': '16', 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2022, 10, 25]]}, 'abstract': '<jats:sec><jats:title>Importance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and ' 'Participants</jats:title><jats:p>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 91 sites in the ' 'US.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Participants ' 'were randomized to receive ivermectin, 400 μg/kg (n\u2009=\u2009817), daily for 3 days or ' 'placebo (n\u2009=\u2009774).</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and ' 'Measures</jats:title><jats:p>Time to sustained recovery, defined as at least 3 consecutive ' 'days without symptoms. There were 7 secondary outcomes, including a composite of ' 'hospitalization or death by day ' '28.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Among 1800 ' 'participants who were randomized (mean [SD] age, 48 [12] years; 932 women [58.6%]; 753 ' '[47.3%] reported receiving at least 2 doses of a SARS-CoV-2 vaccine), 1591 completed the ' 'trial. The hazard ratio (HR) for improvement in time to recovery was 1.07 (95% credible ' 'interval [CrI], 0.96-1.17; posterior <jats:italic>P</jats:italic> value [HR ' '&amp;amp;gt;1]\u2009=\u2009.91). The median time to recovery was 12 days (IQR, 11-13) in the ' 'ivermectin group and 13 days (IQR, 12-14) in the placebo group. There were 10 ' 'hospitalizations or deaths in the ivermectin group and 9 in the placebo group (1.2% vs 1.2%; ' 'HR, 1.1 [95% CrI, 0.4-2.6]). The most common serious adverse events were COVID-19 pneumonia ' '(ivermectin [n\u2009=\u20095]; placebo [n\u2009=\u20097]) and venous thromboembolism ' '(ivermectin [n\u2009=\u20091]; placebo [n\u2009=\u2009' '5]).</jats:p></jats:sec><jats:sec><jats:title>Conclusions and ' 'Relevance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial ' 'Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="https://clinicaltrials.gov/ct2/show/NCT04885530">NCT04885530</jats:ext-link></jats:p></jats:sec>', 'DOI': '10.1001/jama.2022.18590', 'type': 'journal-article', 'created': { 'date-parts': [[2022, 10, 21]], 'date-time': '2022-10-21T18:30:36Z', 'timestamp': 1666377036000}, 'page': '1595', 'source': 'Crossref', 'is-referenced-by-count': 51, 'title': 'Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to ' 'Moderate COVID-19', 'prefix': '10.1001', 'volume': '328', 'author': [ { 'given': 'Susanna', 'family': 'Naggie', 'sequence': 'first', 'affiliation': [ { 'name': 'Duke Clinical Research Institute, Duke University School of ' 'Medicine, Durham, North Carolina'}, { 'name': 'Department of Medicine, Duke University School of Medicine, ' 'Durham, North Carolina'}]}, { 'given': 'David R.', 'family': 'Boulware', 'sequence': 'additional', 'affiliation': [ { 'name': 'Division of Infectious Diseases and International Medicine, ' 'University of Minnesota, Minneapolis'}]}, { 'given': 'Christopher J.', 'family': 'Lindsell', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Biostatistics, Vanderbilt University Medical ' 'Center, Nashville, Tennessee'}]}, { 'given': 'Thomas G.', 'family': 'Stewart', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Biostatistics, Vanderbilt University Medical ' 'Center, Nashville, Tennessee'}]}, { 'given': 'Nina', 'family': 'Gentile', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Emergency Medicine, Lewis Katz School of Medicine ' 'at Temple University, Philadelphia, Pennsylvania'}]}, { 'given': 'Sean', 'family': 'Collins', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Biostatistics, Vanderbilt University Medical ' 'Center, Nashville, Tennessee'}]}, { 'given': 'Matthew William', 'family': 'McCarthy', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Medicine, Weill Cornell Medicine, New York, New ' 'York'}]}, { 'given': 'Dushyantha', 'family': 'Jayaweera', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Medicine, Miller School of Medicine, University of ' 'Miami, Miami, Florida'}]}, { 'given': 'Mario', 'family': 'Castro', 'sequence': 'additional', 'affiliation': [ { 'name': 'Division of Pulmonary, Critical Care and Sleep Medicine, ' 'University of Missouri-Kansas City School of Medicine, Kansas ' 'City, Kansas'}]}, { 'given': 'Mark', 'family': 'Sulkowski', 'sequence': 'additional', 'affiliation': [ { 'name': 'Division of Infectious Diseases, Johns Hopkins University, ' 'Baltimore, Maryland'}]}, { 'given': 'Kathleen', 'family': 'McTigue', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Medicine, University of Pittsburgh Medical Center, ' 'Pittsburgh, Pennsylvania'}]}, { 'given': 'Florence', 'family': 'Thicklin', 'sequence': 'additional', 'affiliation': [{'name': 'Stakeholder Advisory Committee, Pittsburgh, Pennsylvania'}]}, { 'given': 'G. 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