Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)

• Status: Completed
• Trial end date: 2020-12-21
• Target enrollment: 0
• Participant gender: All

Summary

Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro de Estudios en Infectogía Pediatrica
• Treatments: Ivermectin

Criteria

Inclusion Criteria:

• At least 18 years of age

• Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved laboratory

• Beginning of symptoms in the past 7 days

• Mild disease

• Informed consent

Exclusion Criteria:

• Preexisting liver disease

• Hypersensitivity to ivermectin

• Participants in other clinical trials for therapies against COVID-19

• Severe pneumonia

• Pregnant or breastfeeding women

• Concomitant use of warfarin, erdafitinib or quinidine

• Use of ivermectin in the 5 days prior to randomization

• Inability to obtain a blood sample needed to assess liver transaminases

• Elevation of transaminases >1.5 times the normal level

• Participant whose first contact with the study personnel occurs between days 5 and 7 and at that time manifests significant and progressive resolution of COVID-19 related signs and symptoms