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Naggie, Susanna; Boulware, David R.; Lindsell, Christopher J.; Stewart, Thomas G.; Gentile, Nina; Collins, Sean; McCarthy, Matthew William; Jayaweera, Dushyantha; Castro, Mario; Sulkowski, Mark; McTigue, Kathleen; Thicklin, Florence; Felker, G. Michael; Ginde, Adit A.; Bramante, Carolyn T.; Slandzicki, Alex J.; Gabriel, Ahab; Shah, Nirav S.; Lenert, Leslie A.; Dunsmore, Sarah E.; Adam, Stacey J.; DeLong, Allison; Hanna, George; Remaly, April; [...]

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

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  • Medientyp: E-Artikel
  • Titel: Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19 : A Randomized Clinical Trial : A Randomized Clinical Trial
  • Beteiligte: Naggie, Susanna; Boulware, David R.; Lindsell, Christopher J.; Stewart, Thomas G.; Gentile, Nina; Collins, Sean; McCarthy, Matthew William; Jayaweera, Dushyantha; Castro, Mario; Sulkowski, Mark; McTigue, Kathleen; Thicklin, Florence; Felker, G. Michael; Ginde, Adit A.; Bramante, Carolyn T.; Slandzicki, Alex J.; Gabriel, Ahab; Shah, Nirav S.; Lenert, Leslie A.; Dunsmore, Sarah E.; Adam, Stacey J.; DeLong, Allison; Hanna, George; Remaly, April; [...]
  • Erschienen: American Medical Association (AMA), 2022
  • Erschienen in: JAMA
  • Sprache: Englisch
  • DOI: 10.1001/jama.2022.18590
  • ISSN: 0098-7484
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <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 = 817), daily for 3 days or placebo (n = 774).</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] = .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 = 5]; placebo [n = 7]) and venous thromboembolism (ivermectin [n = 1]; placebo [n = 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>