A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
Overview
- Phase
- Phase 3
- Intervention
- Hydroxychloroquine
- Conditions
- Sars-CoV2
- Sponsor
- Military Hospital of Tunis
- Enrollment
- 660
- Locations
- 1
- Primary Endpoint
- SARS CoV2 infection
- Last Updated
- 5 years ago
Overview
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)
Investigators
Eligibility Criteria
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.
Arms & Interventions
Hydroxychloroquine & 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
Intervention: Hydroxychloroquine
Hydroxychloroquine & 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
Intervention: Zinc
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
Intervention: 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
Intervention: Zinc (Placebo)
Placebo
Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months
Intervention: Hydroxychloroquine (placebo)
Placebo
Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months
Intervention: Zinc (Placebo)
Outcomes
Primary Outcomes
SARS CoV2 infection
Time Frame: At 2 months of follow-up
Frequency of confirmed SARS CoV2 infection
Secondary Outcomes
- Adverse Events(each month up to 2 months)
- COVID-19 symptoms description(At 2 months of follow-up)