Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals

Study Overview
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Brief Summary
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Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study

Detailed Description
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Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo

Official Title
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Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study

Conditions
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COVID19, Sars-CoV2, Hydroxychloroquine, Prophylaxis, Healthcare Worker

Intervention / Treatment
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* Drug: Hydroxychloroquine (HCQ)
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COVID-19 (-) Works in a medical intensive care unit exposed to COVID-19 infection 18 years old < age < 65 years old Having given written consent for their participation in the study. Exclusion Criteria: Diagnosis of COVID-19+ Retinopathies, Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study. Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug, Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance < 30 ml/min. Inability to be monitored during the trial period Pregnancy and breastfeeding Psoriasis

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: Arm1:Hydroxychloroquine (HCQ) (200 mg / day) for at least 2 months or until potential contamination**. Arm2:Placebo (1 tablet/day) for at least 2 months or until potential contamination**. ** If the participant is contaminated (COVID19+), he or she will be followed up by telephone according to the study schedule.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine (HCQ)<br>Exposed health care professionals working in the intensive care unit | Drug: Hydroxychloroquine (HCQ)<br>* Hydroxychloroquine (HCQ) 200mg/day<br>* Other names: Plaquenil;|
| Placebo Comparator: Placebo<br>Exposed health care professionals working in the intensive care unit | Drug: Placebo oral tablet<br>* Placebo of Hydroxychloroquine (HCQ) without any active substance<br>* Other names: Placebo of Plaquenil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic COVID(+) infection rate | Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: Cough Dyspnea Fever Myalgia Arthralgia Rhinorrhea Anosmia Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. Biological Examination : Measurement of viral load Ion, liver, kidney, haematological assessment Electrical Examination: ECG | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxychloroquine, HCQ, prophylaxie, Healthcare Worker, COVID19