Ivermectin for Post Exposure Prophylaxis of Covid-19

Study Overview
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Brief Summary
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Post exposure prophylaxis of healthy contacts is among the measures used for outbreak control of several infectious diseases (e.g., pandemic influenza). No agent is known to be effective in preventing COVID-19, but Ivermectin is one of the drugs that have shown antiviral activity against SARS-CoV-2 in the laboratory. This study aims to evaluate the effect of post exposure prophylaxis with Ivermectin after exposure to COVID-19 among the asymptomatic close contacts.

Detailed Description
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Primary Objective: To assess the efficacy of Ivermectin as post exposure prophylaxis in asymptomatic adults (≥18 years of age) who had close-contact exposure to a confirmed case of COVID-19 patient Secondary Objectives: To compare the viral load (using CT value reading) among close contacts who become positive COVID-19 during follow up period between the Ivermectin and placebo group To assess the adverse effects of Ivermectin within 7 days after each dose Study Population and Sampel Size Asymptomatic adults (≥18 years of age) who had recent history (less than 5 days) of close contact exposure to a confirmed COVID-19 positive patient as per the definition by CDC. In this study, the study teams decide to recruit 150 subjects per group, a total of 300 subjects; 30 subjects in each site (15 Ivermectins, 15 placebos)

Official Title
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Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Ivermectin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic individuals exposed to a confirmed positive COVID-19 case within 5 days from the study recruitment day (include household, workplace and social close contact) Aged ≥18 years; male or female No fever with temperature less than 37.5ºC RTK Ag for COVID-19 is negative on the recruitment day. For subject who had received COVID-19 vaccination: Any primary series vaccine (eg: Pfizer, Sinovac, AstraZeneca etc) : past 90 days after the second dose Any booster vaccine: past 90 days after the booster dose In women of childbearing potential (18-55 years old), negative pregnancy test and agree to use any contraceptive method up to 7 days after the second dose of IP administration Have access to video and phone call Willing to take 2 doses of study medication (2 days apart between Dose 1 and Dose 2) Willing to comply with all study procedures Able to provide written informed consent Exclusion Criteria: Unable to take drugs by mouth History of positive confirmed COVID-19 infection within past 3 months Involved in any COVID-19 vaccine clinical trial Patients with suspected concomitant bacterial, fungal infections, concurrent congestive heart failure prior to initiation of study drug Known case of liver disease (any severity) Alcohol intake more than recommended (2 drinks or more in a day for men and 1 drink or more in a day for women) Mal-absorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others). Pregnant or nursing/breastfeeding women or women planning for pregnancy. Female patients who cannot consent to contraceptive use (any method) from the start of IP administration to 7 days after the second dose of IP administration Male patients whose partner cannot agree to use the contraception method as in 9) Patients with a history of gout or on treatment for gout or hyperuricemia Patients receiving immunosuppressant Patients who have previously received Ivermectin. Patients who are not able to provide written consent. Other patients judged ineligible by the principal investigator or sub-investigator

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blind, placebo controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group:<br>Ivermectin 0.4 mg/kg/day (maximum 24 mg) | Drug: Ivermectin<br>* 0.4 mg/kg/day-maximum dose is 24 mg.<br>|
| Placebo Comparator: Control group<br>Placebo-inactive substance | Other: Placebo<br>* Similar to drug in term of tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Covid-19 cases | Comparison of the number of confirmed COVID-19 cases among the close contacts after exposure to a confirmed case of COVID-19 patient in Ivermectin and placebo group | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT value in Covid-19 | Comparison of the CT value between Ivermectin and placebo group | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ivermectin, Post exposure, Prophylaxis