COVID19, Sars-CoV2, Hydroxychloroquine, Prophylaxis, Healthcare Worker
Conditions
Keywords
HCQ, prophylaxie, Healthcare Worker, Hydroxychloroquine, COVID19
Brief summary
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
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
Interventions
Hydroxychloroquine (HCQ) 200mg/day
DRUGPlacebo oral tablet
Placebo of Hydroxychloroquine (HCQ) without any active substance
Sponsors
Eshmoun Clinical Research Center
Datametrix
Abderrahmane Mami Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic COVID(+) infection rate | 60 days | * 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 |
Countries
Tunisia
Outcome results
None listed