A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention

Study Overview
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Brief Summary
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A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis

Detailed Description
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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).

Official Title
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A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Ivermectin Tablets
* Drug: Matching placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years, inclusive. Body weight >45 kg. Body Mass Index >18.5. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening. Only one member in the same household will be enrolled. Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial. Exclusion Criteria: Pregnant or breast-feeding. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study. A positive COVID-19 result (PCR or antigen test) within 8 days of screening. Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening. Hypersensitivity to any component of ivermectin. Participants who have been administered ivermectin within 30 days prior to screening. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.). History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors. Current use of monoclonal antibodies for the treatment of COVID-19.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active IMP<br> | Drug: Ivermectin Tablets<br>* Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.<br>|
| Placebo Comparator: Placebo<br> | Drug: Matching placebo tablets<br>* Daily placebo tablets intake for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 prophylaxis | Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28 | From Day 1 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 prophylaxis timeframe | Time to change from baseline in negative RT-PCR to positive RT-PCR | From Day 1 to Day 28 | 
| COVID-19 symptoms development | Change from baseline in the WHO-COVID 19 and NEWS-2 scores | From Day 1 to Day 28 | 
| COVID-19 symptoms development timeframe | Time to change from baseline to first COVID-19 related clinical events | From Day 1 to Day 28 | 
| COVID-19 hospitalisations | Proportion of COVID-19 related hospitalisations | From Day 1 to Day 56 | 
| COVID-19 mortality | Proportion of COVID-19 related mortality | From Day 1 to Day 56 | 
| Safety and tolerability | Safety and Tolerability of ivermectin based on TEAEs and SAEs | From Day 1 to Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis, RT-PCR test