Status:
WITHDRAWN
Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals
Lead Sponsor:
Abderrahmane Mami Hospital
Collaborating Sponsors:
Eshmoun Clinical Research Center
Datametrix
Conditions:
COVID19
Sars-CoV2
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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. Mul...
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 Hydroxyc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04349228
Start Date
April 28 2020
End Date
July 15 2020
Last Update
August 28 2020
Active Locations (1)
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1
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Tunis, Tunisia