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

Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19

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

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