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Clinical Trial 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 Exposed to SARS CoV2 in Tunisia


Clinical Trial 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 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 Design


Related Conditions & MeSH terms


NCT number NCT04377646
Study type Interventional
Source Military Hospital of Tunis
Contact Faida Ajili, MD
Phone +21698631188
Email faida1977@yahoo.fr
Status Not yet recruiting
Phase Phase 3
Start date May 4, 2020
Completion date July 31, 2020

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