A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
- Conditions
- Sars-CoV2COVID19
- Interventions
- Registration Number
- NCT04377646
- Lead Sponsor
- Military Hospital of Tunis
- 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 Exposed to SARS CoV2 in Tunisia
- 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 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 660
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Zinc (Placebo) Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months Hydroxychloroquine Zinc (Placebo) Will receive: * Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. * Placebo of Zinc Placebo Hydroxychloroquine (placebo) Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months Hydroxychloroquine & Zinc Zinc Will receive: * Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. * Zinc 15 mg at daily dose up to 2 months Hydroxychloroquine & Zinc Hydroxychloroquine Will receive: * Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. * Zinc 15 mg at daily dose up to 2 months Hydroxychloroquine Hydroxychloroquine Will receive: * Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. * Placebo of Zinc
- Primary Outcome Measures
Name Time Method SARS CoV2 infection At 2 months of follow-up Frequency of confirmed SARS CoV2 infection
- Secondary Outcome Measures
Name Time Method Adverse Events each month up to 2 months Any adverse event or serious adverse event
COVID-19 symptoms description At 2 months of follow-up Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)
Trial Locations
- Locations (1)
Military Hospital of Tunis
🇹🇳Tunis, Tunisia