Effect of Early Treatment with Ivermectin among Patients with Covid-19 Academic Article uri icon

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abstract

  • Background

    The efficacy of ivermectin in preventing hospitalization or extended observation in an emergency setting among outpatients with acutely symptomatic coronavirus disease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is unclear.

    Methods

    We conducted a double-blind, randomized, placebo-controlled, adaptive platform trial involving symptomatic SARS-CoV-2-positive adults recruited from 12 public health clinics in Brazil. Patients who had had symptoms of Covid-19 for up to 7 days and had at least one risk factor for disease progression were randomly assigned to receive ivermectin (400 μg per kilogram of body weight) once daily for 3 days or placebo. (The trial also involved other interventions that are not reported here.) The primary composite outcome was hospitalization due to Covid-19 within 28 days after randomization or an emergency department visit due to clinical worsening of Covid-19 (defined as the participant remaining under observation for >6 hours) within 28 days after randomization.

    Results

    A total of 3515 patients were randomly assigned to receive ivermectin (679 patients), placebo (679), or another intervention (2157). Overall, 100 patients (14.7%) in the ivermectin group had a primary-outcome event, as compared with 111 (16.3%) in the placebo group (relative risk, 0.90; 95% Bayesian credible interval, 0.70 to 1.16). Of the 211 primary-outcome events, 171 (81.0%) were hospital admissions. Findings were similar to the primary analysis in a modified intention-to-treat analysis that included only patients who received at least one dose of ivermectin or placebo (relative risk, 0.89; 95% Bayesian credible interval, 0.69 to 1.15) and in a per-protocol analysis that included only patients who reported 100% adherence to the assigned regimen (relative risk, 0.94; 95% Bayesian credible interval, 0.67 to 1.35). There were no significant effects of ivermectin use on secondary outcomes or adverse events.

    Conclusions

    Treatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19 or of prolonged emergency department observation among outpatients with an early diagnosis of Covid-19. (Funded by FastGrants and the Rainwater Charitable Foundation; TOGETHER ClinicalTrials.gov number, NCT04727424.).

authors

  • Reis, Gilmar
  • Silva, Eduardo ASM
  • Silva, Daniela CM
  • Thabane, Lehana
  • Milagres, Aline C
  • Ferreira, Thiago S
  • dos Santos, Castilho VQ
  • Campos, Vitoria HS
  • Nogueira, Ana MR
  • de Almeida, Ana PFG
  • Callegari, Eduardo D
  • Neto, Adhemar DF
  • Savassi, Leonardo CM
  • Simplicio, Maria IC
  • Ribeiro, Luciene B
  • Oliveira, Rosemary
  • Harari, Ofir
  • Forrest, Jamie I
  • Ruton, Hinda
  • Sprague, Sheila
  • McKay, Paula
  • Guo, Christina M
  • Rowland-Yeo, Karen
  • Guyatt, Gordon
  • Boulware, David R
  • Rayner, Craig R
  • Mills, Edward J

publication date

  • May 5, 2022