Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19
| Autor: | Eduardo López-Medina, Pio Lopez, Maria Cristina Lesmes, Ana C. Avendaño, Ernesto Martínez, Hector Chavarriaga, Sócrates Herrera, Jose Oñate, Diana M. Dávalos, Isabella Caicedo, Gerardo Libreros, Dilian Francisca Toro, Jesus A. Díazgranados, Carlos A. Rios, Miyerlandi Torres, Roberto Jaramillo, Beatriz Parra, Oscar Ramirez, Isabel Cristina Hurtado |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Population Placebo 01 natural sciences Drug Administration Schedule law.invention 03 medical and health sciences 0302 clinical medicine Ivermectin Pharmacotherapy Anti-Infective Agents Double-Blind Method Randomized controlled trial law Interquartile range Internal medicine parasitic diseases Humans Medicine Treatment Failure 030212 general & internal medicine 0101 mathematics education Adverse effect Original Investigation Aged education.field_of_study SARS-CoV-2 business.industry 010102 general mathematics Hazard ratio Patient Acuity General Medicine Middle Aged COVID-19 Drug Treatment Female business medicine.drug |
| Zdroj: | JAMA |
| ISSN: | 0098-7484 |
| Popis: | Importance Ivermectin is widely prescribed as a potential treatment for COVID-19 despite uncertainty about its clinical benefit. Objective To determine whether ivermectin is an efficacious treatment for mild COVID-19. Design, Setting, and Participants Double-blind, randomized trial conducted at a single site in Cali, Colombia. Potential study participants were identified by simple random sampling from the state’s health department electronic database of patients with symptomatic, laboratory-confirmed COVID-19 during the study period. A total of 476 adult patients with mild disease and symptoms for 7 days or fewer (at home or hospitalized) were enrolled between July 15 and November 30, 2020, and followed up through December 21, 2020. Intervention Patients were randomized to receive ivermectin, 300 μg/kg of body weight per day for 5 days (n = 200) or placebo (n = 200). Main Outcomes and Measures Primary outcome was time to resolution of symptoms within a 21-day follow-up period. Solicited adverse events and serious adverse events were also collected. Results Among 400 patients who were randomized in the primary analysis population (median age, 37 years [interquartile range {IQR}, 29-48]; 231 women [58%]), 398 (99.5%) completed the trial. The median time to resolution of symptoms was 10 days (IQR, 9-13) in the ivermectin group compared with 12 days (IQR, 9-13) in the placebo group (hazard ratio for resolution of symptoms, 1.07 [95% CI, 0.87 to 1.32];P = .53 by log-rank test). By day 21, 82% in the ivermectin group and 79% in the placebo group had resolved symptoms. The most common solicited adverse event was headache, reported by 104 patients (52%) given ivermectin and 111 (56%) who received placebo. The most common serious adverse event was multiorgan failure, occurring in 4 patients (2 in each group). Conclusion and Relevance Among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms. The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes. Trial Registration ClinicalTrials.gov Identifier:NCT04405843 |
| Databáze: | OpenAIRE |
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