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
Overview
- Phase
- Phase 3
- Intervention
- Hydroxychloroquine (HCQ)
- Conditions
- COVID19
- Sponsor
- Abderrahmane Mami Hospital
- Locations
- 1
- Primary Endpoint
- Symptomatic COVID(+) infection rate
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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
Investigators
Dr Jalila Ben Khelil
Head of department
Abderrahmane Mami Hospital
Eligibility Criteria
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
Arms & Interventions
Hydroxychloroquine (HCQ)
Exposed health care professionals working in the intensive care unit
Intervention: Hydroxychloroquine (HCQ)
Placebo
Exposed health care professionals working in the intensive care unit
Intervention: Placebo oral tablet
Outcomes
Primary Outcomes
Symptomatic COVID(+) infection rate
Time Frame: 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