Eduardo López-Medina1,2,3, Pío López1,2, Isabel C Hurtado2,4, Diana M Dávalos5, Oscar Ramirez3,6,7, Ernesto Martínez8,9, Jesus A Díazgranados10, José M Oñate3,8,11, Hector Chavarriaga12, Sócrates Herrera13, Beatriz Parra14, Gerardo Libreros14, Roberto Jaramillo15, Ana C Avendaño15, Dilian F Toro16, Miyerlandi Torres12, Maria C Lesmes4, Carlos A Rios17, Isabella Caicedo3. 1. Centro de Estudios en Infectología Pediátrica, Cali, Colombia. 2. Department of Pediatrics, Universidad del Valle, Cali, Colombia. 3. Clínica Imbanaco, Cali, Colombia. 4. State Health Department, Valle del Cauca, Colombia. 5. Department of Public Health, Universidad Icesi, Cali, Colombia. 6. POHEMA (Pediatric Oncologist and Hematologist) Foundation, Cali, Colombia. 7. Cali's Cancer Population-based Registry, Cali, Colombia. 8. Department of Internal Medicine, Universidad del Valle, Cali, Colombia. 9. Christus Sinergia Salud, Cali, Colombia. 10. Neurólogos de Occidente, Cali, Colombia. 11. Clínica de Occidente, Cali, Colombia. 12. Municipal Health Department, Cali, Colombia. 13. Caucaseco Scientific Research Center, Malaria Vaccine and Drug Development Center, Cali, Colombia. 14. Department of Microbiology, Universidad del Valle, Cali, Colombia. 15. Hemato Oncólogos, Cali, Colombia. 16. Health Experts Committee, Valle del Cauca, Colombia. 17. Centro Médico Santuario, Cali, Colombia.
Abstract
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.
RCT Entities:
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.
Authors: João João Mendes; José Artur Paiva; Filipe Gonzalez; Paulo Mergulhão; Filipe Froes; Roberto Roncon; João Gouveia Journal: Rev Bras Ter Intensiva Date: 2022-01-24
Authors: Matteo Bassetti; Daniele Roberto Giacobbe; Paolo Bruzzi; Emanuela Barisione; Stefano Centanni; Nadia Castaldo; Silvia Corcione; Francesco Giuseppe De Rosa; Fabiano Di Marco; Andrea Gori; Andrea Gramegna; Guido Granata; Angelo Gratarola; Alberto Enrico Maraolo; Malgorzata Mikulska; Andrea Lombardi; Federico Pea; Nicola Petrosillo; Dejan Radovanovic; Pierachille Santus; Alessio Signori; Emanuela Sozio; Elena Tagliabue; Carlo Tascini; Carlo Vancheri; Antonio Vena; Pierluigi Viale; Francesco Blasi Journal: Infect Dis Ther Date: 2021-07-30
Authors: Dushyantha Jayaweera; Patrick A Flume; Nora G Singer; Myron S Cohen; Anne M Lachiewicz; Amanda Cameron; Naresh Kumar; Joel Thompson; Alyssa Cabrera; Denise Daudelin; Reza Shaker; Philippe R Bauer Journal: J Clin Transl Sci Date: 2021-04-21
Authors: Andrew Bryant; Theresa A Lawrie; Therese Dowswell; Edmund J Fordham; Scott Mitchell; Sarah R Hill; Tony C Tham Journal: Am J Ther Date: 2021-06-21 Impact factor: 2.688