Effect of early treatment with ivermectin among patients with covid-19.
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2022
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BACKGROUND
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.)
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REIS, G. et al. Effect of early treatment with ivermectin among patients with covid-19. The New England Journal of Medicine, v. 386, n. 18, 2022. Disponível em: <https://www.nejm.org/doi/full/10.1056/nejmoa2115869>. Acesso em: 11 out. 2022.