COVID19 Clinical Trial
Official title:
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
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)
;
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