A parallel, prospective, double-blind, placebo-controlled clinical trial will be conducted in
the population affiliated to EPS SURAMERICANA S.A. with positive test for antigen and PCR for
SARS-CoV-2. Participants will be randomly assigned in a 1: 1 ratio to the intervention group
or the control group using a sequence of random numbers. The patients included will be those
with less than 7 days from the onset of symptoms, and without evidence of serious disease.
One group will be assigned oral ivermectin therapy at a dose of 600 mcg/kg every 12 hours for
5 consecutive days, and the other group will received placebo. A minimum sample size of 483
patients for each arm was calculated to observe differences. All randomized patients will be
included in the analysis according to the randomization arm (intention-to-treat analysis).
The primary objective is to evaluate the efficacy of ivermectin in the prevention of severe
disease, reduction in the rate of hospitalization, reduction of ICU stay, and mortality. This
evaluation will be carried out up to 28 days after the intervention begins. Given the public
health emergency, the study is expected to be completed in a period of 6 months from the
INVIMA approval.