Navegando por Autor "Nogueira, Ana Maria R"
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Item Effect of early treatment with ivermectin among patients with covid-19.(2022) Reis, Gilmar; Silva, Eduardo Augusto dos Santos Moreira; Silva, Daniela Carla Medeiros; Thabane, Lehana; Milagres, Aline Cruz; Ferreira, Thiago Santiago; Santos, Castilho Vitor Quirino dos; Campos, Vitoria H. S.; Nogueira, Ana Maria R; Almeida, Ana Paula Figueiredo Guimarães de; Callegari, Eduardo Diniz; Figueiredo Neto, Adhemar Dias de; Savassi, Leonardo Cançado Monteiro; Simplicio, Maria Izabel Campos; Ribeiro, Luciene Barra; Oliveira, Rosemary; Harari, Ofir; Forrest, Jamie I.; Ruton, Hinda; Sprague, Sheila; Mckay, Paula; Guo, Christina M.; Rowland-Yeo, Kanters; Guyatt, Gordon Henry; Boulware, David R.; Rayner, Craig R.; Mills, Edward JosephBACKGROUND The efficacy of ivermectin in preventing hospitalization or extended observation in an emergency setting among outpatients with acutely symptomatic coronavirus dis- ease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coro- navirus 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. Find- ings 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.)