Prophylaxis for COVID-19: Ivermectin in Close Contacts of COVID-19 Cases (IVERNEX-TUC)

Study Overview
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Brief Summary
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Randomized controlled clinical trial on using oral ivermectin in COVID-19 prophylaxis supplying the drug to close contacts of confirmed cases.

Detailed Description
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This is a randomized, double-blind, and controlled clinical trial that aims to evaluate the use of oral ivermectin in COVID-19 prophylaxis. The study has two arms in a relationship of 2:1: Experimental Group (EG n=500) and Placebo Group (CG n=250). The sample size was calculated by applying a two-proportion comparison test. Type of two-sided test, 95% confidence or safety level (1-α), 95% statistical power, 75% P1 (proportion in the placebo group), 65% P2 (proportion in the new treatment or intervention group), size sample without adjustment (n = 543), 25% expected proportion of losses, n= 724 sample adjusted for losses. The hypothesis of the study is that treatment with ivermectin may decrease the chance of occurrence/progress of clinical manifestations and onset of severe disease. Whereas control of the contagion on the first days of development of the disease, this treatment with ivermectin in suspected cases of COVID-19 (by epidemiological nexus) would contribute to the control of contagion at the first part of the infection, even in the absence of symptoms. Categorical variables will be represented with frequencies and proportions, while continuous quantitative variables will be expressed as mean ± standard deviation (SD) or as median and interquartile range (IQR). The proportions will be compared using Pearson's Chi-square test or Fisher's exact test as appropriate, and continuous quantitative variables with Student's t test. The estimation of the efficacy of intensive treatment with Ivermectin will be calculated using Kaplan-Meier curves and the differences will be analyzed by means of the log-rank test. The risk will be calculated as a ratio of advantages for Intensive treatment with Ivermectin (Odds Ratio, OR) with its 95% confidence intervals (95% CI). A value of p <0.05 will be considered significant. Analyzes will be performed using Stata 11.2 software.

Official Title
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Study of Efficacy and Safety of Ivermectin for COVID-19 Prophylaxis in Post-exposure Contact or Epidemiological Link

Conditions
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Covid19

Intervention / Treatment
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* Drug: Ivermectin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years either sex Women of childbearing age with a negative pregnancy test In close contact group or epidemiological nexus of a positive COVID-19 case Able to understand and grant informed consent Real-time - polymerase chain reaction test with a negative result Exclusion Criteria: Known hypersensitivity or allergy to any component of the drug under evaluation Age under 18 years Use of immunosuppressants (including systemic corticosteroids) in the last 30 days Pregnant or lactating Patients with other acute infectious diseases Patients with autoimmune disease and/or chronic decompensated diseases Who have received a vaccine for COVID-19 (1/2 dose) or that have taken ivermectin (prior to 30 days of the study) or who are participating in another COVID-19 prophylaxis study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized controlled. Experimental and Control Group in relationship of 2:1
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The EG receives ivermectin 0,6mg/kg of weight orally on days 1 (one) and 7 (seven) plus standard biosecurity care | Drug: Ivermectin<br>* 0,6mg/kg of weight orally on days 1 and 7<br>* Other names: Iver;|
| Placebo Comparator: Control Group<br>The CG receives a placebo on days 1 (one) and 7 (seven) plus standard biosecurity care | Other: Placebo<br>* A substance with similar physical characteristics as ivermectin, without the active drug ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who were diagnosed with COVID-19 in EG and CG (Negative polymerase chain reaction - real-time). | Pearson's Chi-square and proportion test | At 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contagion risk. | Odd Ratio | Up to 2 weeks | 
| Prophylactic effect associated with patient's preexisting comorbidity | Logistic regression test | Up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ivermectin, Prophylaxis, COVID-19, Epidemiological link