Back to resultsA Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
Primary Purpose
Sars-CoV2, COVID19
Status
Unknown status
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Hydroxychloroquine
Hydroxychloroquine (placebo)
Zinc
Zinc (Placebo)
Sponsored by
About this trial
This is an interventional prevention trial for Sars-CoV2 focused on measuring Prophylaxis, Zinc, Hydroxychloroquine, Health Professionals, Military
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
Sites / Locations
- Military Hospital of Tunis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Hydroxychloroquine & Zinc
Hydroxychloroquine
Placebo
Arm 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
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
Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months
Outcomes
Primary Outcome Measures
SARS CoV2 infection
Frequency of confirmed SARS CoV2 infection
Secondary Outcome Measures
COVID-19 symptoms description
Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)
Adverse Events
Any adverse event or serious adverse event
Full Information
NCT ID
NCT04377646
First Posted
May 1, 2020
Last Updated
May 4, 2020
Sponsor
Military Hospital of Tunis
Collaborators
UR17DN02 : Autoimmune Diseases Research Unit, Dacima Consulting
1. Study Identification
Unique Protocol Identification Number
NCT04377646
Brief Title
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
Acronym
COVID-Milit
Official Title
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2020 (Anticipated)
Primary Completion Date
May 24, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Military Hospital of Tunis
Collaborators
UR17DN02 : Autoimmune Diseases Research Unit, Dacima Consulting
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV2, COVID19
Keywords
Prophylaxis, Zinc, Hydroxychloroquine, Health Professionals, Military
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized clinical trial with 3 arms
Masking
ParticipantCare ProviderInvestigator
Masking Description
Random blind allocation.
Allocation
Randomized
Enrollment
660 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine & Zinc
Arm Type
Active Comparator
Arm 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
Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine (placebo)
Intervention Description
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Description
15 mg per day up to 2 months
Intervention Type
Drug
Intervention Name(s)
Zinc (Placebo)
Intervention Description
1 pill per day up to 2 months
Primary Outcome Measure Information:
Title
SARS CoV2 infection
Description
Frequency of confirmed SARS CoV2 infection
Time Frame
At 2 months of follow-up
Secondary Outcome Measure Information:
Title
COVID-19 symptoms description
Description
Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)
Time Frame
At 2 months of follow-up
Title
Adverse Events
Description
Any adverse event or serious adverse event
Time Frame
each month up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faida Ajili, MD
Phone
+21698631188
Email
faida1977@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Neja Stambouli, PhD
Phone
+21655104234
Email
nejlastam@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faida Ajili, MD
Organizational Affiliation
Military Hospital of Tunis
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nejla Mrabet, PhD
Organizational Affiliation
Military Hospital of Tunis
Official's Role
Study Director
Facility Information:
Facility Name
Military Hospital of Tunis
City
Tunis
Country
Tunisia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faida Ajili, MD
Phone
+21698631188
Email
faida1977@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Nejla Stambouli, PhD
Phone
+21655104234
Email
nejlastam@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
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