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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377646
Recruitment Status : Unknown
Verified May 2020 by Military Hospital of Tunis.
Recruitment status was:  Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
UR17DN02 : Autoimmune Diseases Research Unit
Dacima Consulting
Information provided by (Responsible Party):
Military Hospital of Tunis

Study Description
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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

Condition or disease Intervention/treatment Phase
Sars-CoV2 COVID19 Drug: Hydroxychloroquine Drug: Hydroxychloroquine (placebo) Drug: Zinc Drug: Zinc (Placebo) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized clinical trial with 3 arms
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Random blind allocation.
Primary Purpose: Prevention
Official Title: A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
Estimated Study Start Date : May 4, 2020
Estimated Primary Completion Date : May 24, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Hydroxychloroquine (placebo)
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months

Drug: Zinc (Placebo)
1 pill per day up to 2 months


Outcome Measures
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Primary Outcome Measures :
  1. SARS CoV2 infection [ Time Frame: At 2 months of follow-up ]
    Frequency of confirmed SARS CoV2 infection


Secondary Outcome Measures :
  1. COVID-19 symptoms description [ Time Frame: At 2 months of follow-up ]
    Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)

  2. Adverse Events [ Time Frame: each month up to 2 months ]
    Any adverse event or serious adverse event


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377646


Contacts
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Contact: Faida Ajili, MD +21698631188 faida1977@yahoo.fr
Contact: Neja Stambouli, PhD +21655104234 nejlastam@gmail.com

Locations
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Tunisia
Military Hospital of Tunis
Tunis, Tunisia
Contact: Faida Ajili, MD    +21698631188    faida1977@yahoo.fr   
Contact: Nejla Stambouli, PhD    +21655104234    nejlastam@gmail.com   
Sponsors and Collaborators
Military Hospital of Tunis
UR17DN02 : Autoimmune Diseases Research Unit
Dacima Consulting
Investigators
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Study Chair: Faida Ajili, MD Military Hospital of Tunis
Study Director: Nejla Mrabet, PhD Military Hospital of Tunis
More Information
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Responsible Party: Military Hospital of Tunis
ClinicalTrials.gov Identifier: NCT04377646    
Other Study ID Numbers: UR17DN02-001
TN2020-NAT-INS-38 ( Other Identifier: Tunisian Ministry of Health )
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Military Hospital of Tunis:
Prophylaxis
Zinc
Hydroxychloroquine
Health Professionals
Military
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
 Zinc
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Trace Elements
Micronutrients
Physiological Effects of Drugs