BMC Infectious Diseases (Dec 2022)

Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trial

  • Carmen de la Rocha,
  • Marco A. Cid-López,
  • Blanca I. Venegas-López,
  • Sandra C. Gómez-Méndez,
  • Adriana Sánchez-Ortiz,
  • Alma M. Pérez-Ríos,
  • Ricardo A. Llamas-Velázquez,
  • Aidé I. Meza-Acuña,
  • Bárbara Vargas-Íñiguez,
  • Daniela Rosales-Galván,
  • Alejandra Tavares-Váldez,
  • Nizdali Luna-Gudiño,
  • Cinthia V. Hernández-Puente,
  • Jovana Milenkovic,
  • Cecilia Iglesias-Palomares,
  • Miriam Méndez-del Villar,
  • Gerardo A. Gutiérrez-Dieck,
  • Carlos G. Valderrábano-Roldán,
  • Jennefer Mercado-Cerda,
  • Jocelyn G. Robles-Bojórquez,
  • Arieh R. Mercado-Sesma

DOI
https://doi.org/10.1186/s12879-022-07890-6
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 9

Abstract

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Abstract Background Despite the development and application of vaccines against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) around the world, the scientific community is still trying to find some therapies to avoid or ameliorate the fatal evolution of the Coronavirus disease 2019 (COVID-19). Since the publication of the potential use of ivermectin as a treatment against the disease, a pleiad of information about it has been published. However, the evidence is not strong or weak enough to conclude its usefulness in the clinical evolution of patients infected with SARS-CoV-2. We evaluate the efficacy and safety of ivermectin in the treatment of Mexican patients with asymptomatic and mild COVID-19 in a three-day administration in comparison to placebo. Methods A randomized, double-blind, placebo-controlled trial was carried out in 66 adults with asymptomatic and mild COVID-19. Patients were randomly assigned 1:1 ratio to ivermectin plus acetaminophen or placebo plus acetaminophen. The primary endpoint was the proportion of subjects without a disease progression to severity according to COVID-19 guidelines by the National Institutes of Health (NIH) since randomization to 14 days. Results None of the participants presented progression to a severe state in either group. Viral load was measured on Days 1, 5, and 14. No significant differences were observed in baseline or 14-day between groups (p = 0.720 and 0.362, respectively). However, on Day 5, a significant difference in viral load was observed between groups (p = 0.039). The frequency of symptoms was similar between groups, and no significant differences were observed. The most frequent symptom was cough. One severe adverse event associated with SARS-CoV-2 infection was observed in the ivermectin group. Conclusions At standard doses, ivermectin is not effective to prevent progression to a severe state or reducing symptoms in adults with asymptomatic and mild COVID-19. Trial registration The study was registered with ClinicalTrial.gov (NCT04407507) on May 29, 2020.

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