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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-28

Study Completion Date

2020-07-15

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

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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

Conditions

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COVID19 Sars-CoV2 Hydroxychloroquine Prophylaxis Healthcare Worker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

As the trial is open-label and to preserve the validity of the trial, the measurement of the endpoint must be blinded by a third party (i.e., an evaluator who is not aware of the arm to which the patient has been assigned or the treatment the patient is receiving) using the PROBE ("Prospective Randomized Open Blinded Endpoint") method.

Study Groups

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Hydroxychloroquine (HCQ)

Exposed health care professionals working in the intensive care unit

Group Type EXPERIMENTAL

Hydroxychloroquine (HCQ)

Intervention Type DRUG

Hydroxychloroquine (HCQ) 200mg/day

Placebo

Exposed health care professionals working in the intensive care unit

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo of Hydroxychloroquine (HCQ) without any active substance

Interventions

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Hydroxychloroquine (HCQ)

Hydroxychloroquine (HCQ) 200mg/day

Intervention Type DRUG

Placebo oral tablet

Placebo of Hydroxychloroquine (HCQ) without any active substance

Intervention Type DRUG

Other Intervention Names

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Plaquenil Placebo of Plaquenil

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes