Efficacy of Ivermectin in Outpatients With Non-severe COVID-19

Study Overview
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Brief Summary
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This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.

Detailed Description
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This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease. Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo. The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria.

Official Title
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Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial

Conditions
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Covid19, Coronavirus Infection

Intervention / Treatment
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* Drug: Ivermectin Tablets
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2 Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2. Patients who agree to participate in the study by signing the informed consent. Exclusion Criteria: Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020) Pregnant or breastfeeding women Women of childbearing age and without commitment to use contraceptive methods during the study time. Inability to complete the study Current treatment with drugs known to interact with ivermectin Known intolerance to ivermectin, its derivate or any of its excipients. Patients with known Child-Pugh C liver disease Patients with prior ivermectin consumption in the 10 days prior to study entry.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing hospitalization in outpatients with COVID-19.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin<br>Ivermectin 200mcg/kg single dose, maximum dose 18mg | Drug: Ivermectin Tablets<br>* Oral ivermectin at a one time dose<br>|
| Placebo Comparator: Placebo<br>Inactive medication tablets indistinguishable from ivermectin tablets | Other: Placebo<br>* Oral placebo at a one time dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with hospitalization criteria | Proportion of patients with hospitalization criteria at day 30 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with COVID-19 signs and symptoms | Proportion of patients with COVID-19 signs and symptoms up to day 14 | 14 days | 
| Proportion of cohabitants who had COVID-19 after the index case | Proportion of cohabitants who had COVID-19 after the index case up to day 30 | 30 days | 
| Drug-related adverse events | Proportion of patients with ivermectin adverse events up to day 30 | 30 days | 
| Levels of IgG for SARS-CoV-2 | Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay | 30-60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ivermectin, Communicable Diseases, Respiratory Tract Infections