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

COVID19 Clinical Trial

— COVID-Milit  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04377646
• Other study ID #: UR17DN02-001
• Secondary ID: TN2020-NAT-INS-3
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 4, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: May 2020
• Source: Military Hospital of Tunis
• Contact: Faida Ajili, MD
• Phone: +21698631188
• Email: faida1977[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 660
• Est. completion date: July 31, 2020
• Est. primary completion date: May 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID19
• Infection
• Sars-CoV2

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Tunisia	Military Hospital of Tunis	Tunis

Sponsors (3)

Lead Sponsor	Collaborator
Military Hospital of Tunis	Dacima Consulting, UR17DN02 : Autoimmune Diseases Research Unit

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS CoV2 infection	Frequency of confirmed SARS CoV2 infection	At 2 months of follow-up
Secondary	COVID-19 symptoms description	Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)	At 2 months of follow-up
Secondary	Adverse Events	Any adverse event or serious adverse event	each month up to 2 months