A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis
This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
400
Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.
Daily placebo tablets intake for 28 days
Medical Center Medic Ltd.
Sofia, Bulgaria
COVID-19 Prophylaxis
Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28
Time frame: From Day 1 to Day 28
COVID-19 Symptoms Development
Number of symptomatic Participants according to the WHO COVID-18 scale
Time frame: From Day 1 to Day 28
COVID-19 Prophylaxis Timeframe
Time to change from baseline in negative RT-PCR to positive RT-PCR
Time frame: From Day 1 to Day 28
COVID-19 Hospitalisations
Proportion of COVID-19 related hospitalisations
Time frame: From Day 1 to Day 56
COVID-19 Mortality
Proportion of COVID-19 related mortality
Time frame: From Day 1 to Day 56
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days
Descriptive comparison of AE rates and severity/seriousness between IVM and placebo
Time frame: 56 days
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