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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
966
Treatment with Ivermectin in the first 7 days from symptoms onset.
Treatment with Placebo in the first 7 days from symptoms onset.
Composite Outcome
Proportion of patients progressing to severe COVID-19. Progression to severe disease will be considered when at least one of the following clinical situations occurs (composite outcome) the first thing that occurs in each patient during the 28 days after the intervention begins: 1. Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program; or 2. Need for hospitalization includes general bed, ICU or ICU; or 3. Death from any cause.
Time frame: 28 days
Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program.
Time frame: 28 days
Need for hospitalization including general bed, ICU or ICU.
Time frame: 28 days
Death from any cause.
Time frame: 28 days
Proportion of patients with 4 or more points on the WHO scale (8-point ordinal scale).
Time frame: 28 days
Number of days with supplemental oxygen requirement.
Time frame: 28 days
Number of days on ICU management.
Time frame: 28 days
Number of days on endotracheal intubation (IOT).
Time frame: 28 days
Number of days of hospitalization.
Time frame: 28 days
Number and type of serious and non-serious adverse events.
Time frame: 28 days
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