A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)

Military Hospital of Tunis

Status and phase: Unknown; Phase 3

Conditions: Sars-CoV2; COVID19

Treatments: Drug: Hydroxychloroquine (placebo); Drug: Hydroxychloroquine; Drug: Zinc; Drug: Zinc (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT04377646

UR17DN02-001

TN2020-NAT-INS-38 (Other Identifier)

Details and patient eligibility

About

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

Full 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)

Enrollment: 660 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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660 participants in 3 patient groups, including a placebo group

Hydroxychloroquine & Zinc

Active Comparator group

Description:

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

Treatment:

Drug: Zinc

Drug: Hydroxychloroquine

Hydroxychloroquine

Active Comparator group

Description:

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

Treatment:

Drug: Zinc (Placebo)

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Description:

Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months

Treatment:

Drug: Zinc (Placebo)

Drug: Hydroxychloroquine (placebo)