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
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
Drug: Hydroxychloroquine (HCQ)
Hydroxychloroquine (HCQ) 200mg/day
Other Name: Plaquenil
Drug: Placebo oral tablet
Placebo of Hydroxychloroquine (HCQ) without any active substance
Other Name: Placebo of Plaquenil
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
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Tunis, Tunisia
Jalila Ben Khelil, Pr, Principal Investigator
Hopital Abderrahmane Mami