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)
Drug: Hydroxychloroquine
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
Drug: Hydroxychloroquine (placebo)
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
Drug: Zinc
15 mg per day up to 2 months
Drug: Zinc (Placebo)
1 pill per day up to 2 months
Inclusion Criteria:
- 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 Criteria:
- 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
Military Hospital of Tunis
Tunis, Tunisia
Investigator: Faida Ajili, MD
Contact: +21698631188
faida1977@yahoo.fr
Faida Ajili, MD
+21698631188
faida1977@yahoo.fr
Neja Stambouli, PhD
+21655104234
nejlastam@gmail.com