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

Autor: de la Rocha C; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México.; Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de La Salud, Universidad de Guadalajara, Tonalá, Jalisco, México., Cid-López MA; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Venegas-López BI; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Gómez-Méndez SC; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Sánchez-Ortiz A; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Pérez-Ríos AM; Hospital Regional de Zona 110, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, Mexico., Llamas-Velázquez RA; Department Hospital Ángeles del Carmen, Hospitalization and Farmacovigilance Department, Guadalajara, Jalisco, Mexico., Meza-Acuña AI; Hospital Regional de Zona 110, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, Mexico., Vargas-Íñiguez B; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Rosales-Galván D; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Tavares-Váldez A; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Luna-Gudiño N; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Hernández-Puente CV; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Milenkovic J; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Iglesias-Palomares C; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Méndez-Del Villar M; Centro de Investigación Multidisciplinaria en Salud, Centro Universitario de Tonalá, Universidad de Guadalajara, Av. Nuevo Periférico 555, Ejido San José Tateposco, CP45425, Tonalá, Jalisco, México., Gutiérrez-Dieck GA; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Valderrábano-Roldán CG; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Mercado-Cerda J; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Robles-Bojórquez JG; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México., Mercado-Sesma AR; Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México. arieh.mercado@academicos.udg.mx.; Centro de Investigación Multidisciplinaria en Salud, Centro Universitario de Tonalá, Universidad de Guadalajara, Av. Nuevo Periférico 555, Ejido San José Tateposco, CP45425, Tonalá, Jalisco, México. arieh.mercado@academicos.udg.mx.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2022 Dec 08; Vol. 22 (1), pp. 917. Date of Electronic Publication: 2022 Dec 08.
DOI: 10.1186/s12879-022-07890-6
Abstrakt: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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