A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers

Study Overview
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Brief Summary
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A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia

Detailed Description
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Detailed Description: The study is a multicenter randomized controlled double blind clinical trial, including up to 660 military health professionals working in Tunisia and exposed to SARS CoV2 at different levels (2 levels of exposure). The trial will assess the efficacy of hydroxychloroquine associated to Zinc compared to hydrxyochloroquine. Randomization will be performed by IWRS (Interactive Web Response System) by random double blocs of 9 and 6. Collected data are managed by the electronic data capture system (DACIMA Clinical Suite),according to the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the EU GDPR (European General Data Protection Regulation), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)

Official Title
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A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)

Conditions
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Sars-CoV2, COVID19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Hydroxychloroquine (placebo)
* Drug: Zinc
* Drug: Zinc (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No self-medication with chloroquine, hydroxychloroquine or antivirals COVID-19 negative diagnosis confirmed by rapid test and PCR test (Polymerase Chain Reaction test) No clinical symptoms suggestive of COVID-19 Having given written consent for their participation in the study Exclusion Criteria: Participation in other clinical trials for the treatment or prevention of SARS-COV-2 infection within 30 days before inclusion Hypersensitivity to any of the drugs or to any of its excipients. ECG showing rhythm disturbances, QT interval> 500 ms, conduction disturbances. Severe hepatic impairment. Concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol. Retinal pathology. Epilepsy. Myasthenia. Psoriasis. Methemoglobinemia. Porphyria. Pregnant or lactating women Contraindication to the study products

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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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: Double blind randomized clinical trial with 3 arms
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydroxychloroquine & Zinc<br>Will receive: Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. Zinc 15 mg at daily dose up to 2 months | Drug: Hydroxychloroquine<br>* 400 mg at day 1 and day 2, then 400 mg weekly up to 2 months<br>Drug: Zinc<br>* 15 mg per day up to 2 months<br>|
| Active Comparator: Hydroxychloroquine<br>Will receive: Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. Placebo of Zinc | Drug: Hydroxychloroquine<br>* 400 mg at day 1 and day 2, then 400 mg weekly up to 2 months<br>Drug: Zinc (Placebo)<br>* 1 pill per day up to 2 months<br>|
| Placebo Comparator: Placebo<br>Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months | Drug: Hydroxychloroquine (placebo)<br>* 1 pill at day 1 and day 2, then 1 pill weekly up to 2 months<br>Drug: Zinc (Placebo)<br>* 1 pill per day up to 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS CoV2 infection | Frequency of confirmed SARS CoV2 infection | At 2 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 symptoms description | Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness) | At 2 months of follow-up | 
| Adverse Events | Any adverse event or serious adverse event | each month up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis, Zinc, Hydroxychloroquine, Health Professionals, Military