Efficacy of Ivermectin in Outpatients With Non-severe COVID-19

• Status: Recruiting
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Nacional de Asunción
• Collaborators: Centro de información y recursos para el desarrollo, Paraguay; Centro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay; Consejo Nacional de Ciencias y Tecnologia, Paraguay; Instituto Desarrollo, Paraguay; Ministerio de Salud Pública y Bienestar Social, Paraguay
• Treatments: Ivermectin

Criteria

Inclusion Criteria:

• Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2

• Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2.

• Patients who agree to participate in the study by signing the informed consent.

Exclusion Criteria:

• Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020)

• Pregnant or breastfeeding women

• Women of childbearing age and without commitment to use contraceptive methods during the study time.

• Inability to complete the study

• Current treatment with drugs known to interact with ivermectin

• Known intolerance to ivermectin, its derivate or any of its excipients.

• Patients with known Child-Pugh C liver disease

• Patients with prior ivermectin consumption in the 10 days prior to study entry.