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Ivermectina Colombia (IVERCOL)

NCT04886362 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 966

Last updated 2021-05-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ayudas Diagnosticas Sura S.A.S

    lead OTHER

Principal Investigators

  • Juan Carlos Chacón Jimenez, MD · Emergencies Department Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2021-09-30
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886362 on ClinicalTrials.gov