NCT04886362

Ivermectina Colombia (IVERCOL)

Safety and Efficacy and of Ivermectin for the Prevention of Severe Disease in Patients With COVID-19: A Randomized, Controlled, Double-Blind Clinical Study.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 966 (estimated)
• Sponsor: Ayudas Diagnosticas Sura S.A.S · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
DRUG	Ivermectin	Treatment with Ivermectin in the first 7 days from symptoms onset.
DRUG	Placebo	Treatment with Placebo in the first 7 days from symptoms onset.

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2021-05-14
• Last updated: 2021-05-14