COVID19, Sars-CoV2
Conditions
Keywords
Prophylaxis, Zinc, Hydroxychloroquine, Health Professionals, Military
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)
Interventions
DRUGHydroxychloroquine
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
DRUGHydroxychloroquine (placebo)
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
DRUGZinc
15 mg per day up to 2 months
DRUGZinc (Placebo)
1 pill per day up to 2 months
Sponsors
UR17DN02 : Autoimmune Diseases Research Unit
Dacima Consulting
Military Hospital of Tunis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Random blind allocation.
Intervention model description
Double blind randomized clinical trial with 3 arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS CoV2 infection | At 2 months of follow-up | Frequency of confirmed SARS CoV2 infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Adverse Events | each month up to 2 months | Any adverse event or serious adverse event |
Countries
Tunisia
Contacts
Primary ContactFaida Ajili, MD
Backup ContactNeja Stambouli, PhD
Outcome results
None listed