A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
NCT ID: NCT04377646
Last Updated: 2020-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
660 participants
INTERVENTIONAL
2020-05-04
2020-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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
Hydroxychloroquine
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
Zinc
15 mg per day up to 2 months
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
Hydroxychloroquine
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
Zinc (Placebo)
1 pill per day up to 2 months
Placebo
Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months
Hydroxychloroquine (placebo)
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
Zinc (Placebo)
1 pill per day up to 2 months
Interventions
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Hydroxychloroquine
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
Hydroxychloroquine (placebo)
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
Zinc
15 mg per day up to 2 months
Zinc (Placebo)
1 pill per day up to 2 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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UR17DN02 : Autoimmune Diseases Research Unit
UNKNOWN
Dacima Consulting
OTHER
Military Hospital of Tunis
OTHER
Responsible Party
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Principal Investigators
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Faida Ajili, MD
Role: STUDY_CHAIR
Military Hospital of Tunis
Nejla Mrabet, PhD
Role: STUDY_DIRECTOR
Military Hospital of Tunis
Locations
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Military Hospital of Tunis
Tunis, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TN2020-NAT-INS-38
Identifier Type: OTHER
Identifier Source: secondary_id
UR17DN02-001
Identifier Type: -
Identifier Source: org_study_id
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