Clinical trial NCT04377646: A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
Official title: A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sars-CoV2
COVID19
Keywords: Prophylaxis
Zinc
Hydroxychloroquine
Health Professionals
Military
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
Collaborators: name: UR17DN02 : Autoimmune Diseases Research Unit
name: Dacima Consulting
First posted: 2020-05-06
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized clinical trial with 3 arms
Primary purpose: PREVENTION

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)

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.
* Porphyria.
* Pregnant or lactating women
* Contraindication to the study products

Primary outcomes:
measure: SARS CoV2 infection
timeFrame: At 2 months of follow-up
Secondary outcomes:
measure: COVID-19 symptoms description
timeFrame: At 2 months of follow-up
measure: Adverse Events
timeFrame: each month up to 2 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
Study officials:
affiliation: Military Hospital of Tunis
name: Faida Ajili, MD
role: STUDY_CHAIR
affiliation: Military Hospital of Tunis
name: Nejla Mrabet, PhD
role: STUDY_DIRECTOR
References: