Trials / Unknown
UnknownNCT04377646
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- Sponsor
- Military Hospital of Tunis · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-05-04
- Primary completion
- 2020-05-24
- Completion
- 2020-07-31
- First posted
- 2020-05-06
- Last updated
- 2020-05-06
Locations
1 site across 1 country: Tunisia
Source: ClinicalTrials.gov record NCT04377646. Inclusion in this directory is not an endorsement.