Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study prot
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LETTER
Open Access
Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial Julio Vallejos1, Rodrigo Zoni1* , Maria Bangher1, Silvina Villamandos1, Angelina Bobadilla2, Fabian Plano2, Claudia Campias2, Evangelina Chaparro Campias2, Fernando Achinelli2, Hector A. Guglielmone2, Jorge Ojeda2, Fernanda Medina1, Diego Farizano Salazar2, Gerardo Andino2, Natalia E. Ruiz Diaz2, Pablo Kawerin2, Elba Meza2, Silvana Dellamea2, Antonia Aquino2, Victor Flores2, Carolina N. Martemucci2, María Mercedes Vernengo2, Silvina María Martinez2, Juan Emanuel Segovia2 and María Gabriela Aguirre1
Abstract Objectives: To assess the efficacy of ivermectin in addition to standard treatment compared to standard treatment alone in reducing hospitalizations in the COVID-19 patient population. Trial design: IVERCOR-COVID19 will be a single-center, prospective, randomized, double-blind, parallel group (1:1 ratio), placebo-controlled study. Participants: Patients who meet the following criteria will be invited to participate: Inclusion criteria: (1) Over 18 years of age who reside in the province of Corrientes at the time of diagnosis. (2) Confirmed diagnosis of COVID-19 by polymerase chain reaction (PCR) test for detection of SARS-CoV2 in the last 48 h. (3) In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal, or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least 1 month before the time of inviting her to participate in this study). (4) Weight at the time of inclusion greater than 48 kg. (5) That they sign the informed consent for participation in the study. Exclusion criteria: (1) pregnant or breastfeeding women; (2) known allergy to ivermectin or some of the components of ivermectin tablets or placebo; (3) current use of home oxygen; (4) require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19; (5) presence of mal-absorptive syndrome; (6) presence of any other concomitant acute infectious disease; (7) known history of severe liver disease, (Continued on next page)
* Correspondence: [email protected] 1 Instituto de Cardiología de Corrientes “Juana F. Cabral”, Corrientes, Argentina Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Cr
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