Status:
UNKNOWN
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
Lead Sponsor:
Military Hospital of Tunis
Collaborating Sponsors:
UR17DN02 : Autoimmune Diseases Research Unit
Dacima Consulting
Conditions:
Sars-CoV2
COVID19
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Expose...
Detailed Description
Detailed Description: The study is a multicenter randomized controlled double blind clinical trial, including up to 660 military health professionals working in Tunisia and exposed to SARS CoV2 at dif...
Eligibility Criteria
Inclusion
- No self-medication with chloroquine, hydroxychloroquine or antivirals
- COVID-19 negative diagnosis confirmed by "rapid test" and "PCR test" (Polymerase Chain Reaction test)
- No clinical symptoms suggestive of COVID-19
- Having given written consent for their participation in the study
Exclusion
- Participation in other clinical trials for the treatment or prevention of SARS-COV-2 infection within 30 days before inclusion
- Hypersensitivity to any of the drugs or to any of its excipients.
- ECG showing rhythm disturbances, QT interval\> 500 ms, conduction disturbances.
- Severe hepatic impairment.
- Concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol.
- Retinal pathology.
- Epilepsy.
- Myasthenia.
- Psoriasis.
- Methemoglobinemia.
- Porphyria.
- Pregnant or lactating women
- Contraindication to the study products
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT04377646
Start Date
May 4 2020
End Date
July 31 2020
Last Update
May 6 2020
Active Locations (1)
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1
Military Hospital of Tunis
Tunis, Tunisia