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 Exposed to SARS CoV2 in Tunisia
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 different levels (2 levels of exposure). The trial will assess the efficacy of hydroxychloroquine associated to Zinc compared to hydrxyochloroquine. Randomization will be performed by IWRS (Interactive Web Response System) by random double blocs of 9 and 6. Collected data are managed by the electronic data capture system (DACIMA Clinical Suite),according to the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the EU GDPR (European General Data Protection Regulation), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
660
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
15 mg per day up to 2 months
Military Hospital of Tunis
Tunis, Tunisia
SARS CoV2 infection
Frequency of confirmed SARS CoV2 infection
Time frame: At 2 months of follow-up
COVID-19 symptoms description
Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)
Time frame: At 2 months of follow-up
Adverse Events
Any adverse event or serious adverse event
Time frame: each month up to 2 months
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1 pill per day up to 2 months