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

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

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

Study Overview

• Status: Unknown
• Conditions: COVID19; Sars-CoV2
• Intervention / Treatment: Drug: Hydroxychloroquine; Drug: Zinc; Drug: Zinc (Placebo); Drug: Hydroxychloroquine (placebo)

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)

• Study Type: Interventional
• Enrollment (Anticipated): 660
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Military Hospital of Tunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Hydroxychloroquine; 400 mg at day 1 and day 2, then 400 mg weekly up to 2 months; Drug: Zinc; 15 mg per day up to 2 months
Active Comparator: 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	Drug: Hydroxychloroquine; 400 mg at day 1 and day 2, then 400 mg weekly up to 2 months; Drug: Zinc (Placebo); 1 pill per day up to 2 months
Placebo Comparator: Placebo; Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months	Drug: Zinc (Placebo); 1 pill per day up to 2 months; Drug: Hydroxychloroquine (placebo); 1 pill at day 1 and day 2, then 1 pill weekly up to 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS CoV2 infection	Frequency of confirmed SARS CoV2 infection	At 2 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse Events	Any adverse event or serious adverse event	each month up to 2 months

Collaborators and Investigators

• Sponsor: Military Hospital of Tunis
• Collaborators: Dacima Consulting; UR17DN02 : Autoimmune Diseases Research Unit
• Investigators: Study Director: Nejla Mrabet, PhD, Military Hospital of Tunis

Study record dates

Study Major Dates

• Study Start (Anticipated): May 4, 2020
• Primary Completion (Anticipated): May 24, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Health Professionals; Prophylaxis; Hydroxychloroquine; Military; Zinc
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Trace Elements; Micronutrients; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine; Zinc
• Other Study ID Numbers: UR17DN02-001; TN2020-NAT-INS-38 (Other Identifier: Tunisian Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No