Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms

Summary

This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19). The primary efficacy endpoint is the proportion of participants with a disease control status defined as no progression of severe disease Hypothesis (H0): There is no difference between group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the primary endpoint on day 14.

Timeline

Start

2020-07-01

Primary completion

2021-01-29

Completion

2021-01-29

Publications

• Results Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
• Results Chaccour CJ, Kobylinski KC, Bassat Q, Bousema T, Drakeley C, Alonso P, Foy BD. Ivermectin to reduce malaria transmission: a research agenda for a promising new tool for elimination. Malar J. 2013 May 7;12:153. doi: 10.1186/1475-2875-12-153.
• Results Smit MR, Ochomo E, Aljayyoussi G, Kwambai T, Abong'o B, Bayoh N, Gimnig J, Samuels A, Desai M, Phillips-Howard PA, Kariuki S, Wang D, Ward S, Ter Kuile FO. Efficacy and Safety of High-Dose Ivermectin for Reducing Malaria Transmission (IVERMAL): Protocol for a Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Trial in Western Kenya. JMIR Res Protoc. 2016 Nov 17;5(4):e213. doi: 10.2196/resprot.6617.
• Results Xie M, Chen Q. Insight into 2019 novel coronavirus - An updated interim review and lessons from SARS-CoV and MERS-CoV. Int J Infect Dis. 2020 May;94:119-124. doi: 10.1016/j.ijid.2020.03.071. Epub 2020 Apr 1.
• Results Yang SNY, Atkinson SC, Wang C, Lee A, Bogoyevitch MA, Borg NA, Jans DA. The broad spectrum antiviral ivermectin targets the host nuclear transport importin alpha/beta1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3.
• de la Rocha C, Cid-Lopez MA, Venegas-Lopez BI, Gomez-Mendez SC, Sanchez-Ortiz A, Perez-Rios AM, Llamas-Velazquez RA, Meza-Acuna AI, Vargas-Iniguez B, Rosales-Galvan D, Tavares-Valdez A, Luna-Gudino N, Hernandez-Puente CV, Milenkovic J, Iglesias-Palomares C, Mendez-Del Villar M, Gutierrez-Dieck GA, Valderrabano-Roldan CG, Mercado-Cerda J, Robles-Bojorquez JG, Mercado-Sesma AR. Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trial. BMC Infect Dis. 2022 Dec 8;22(1):917. doi: 10.1186/s12879-022-07890-6.

Drugs

Indications