A Study of Hydroxychloroquine and Zinc in the Prevention... | NCT04377646

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

NCT04377646

Sponsor

Military Hospital of Tunis

Status

Unknown status

Last Update Posted

May 6, 2020Actual

Enrollment

660Estimated

Phase

Phase 3

Conditions

Sars-CoV2
COVID19

Interventions

Hydroxychloroquine
Hydroxychloroquine (placebo)
Zinc
Zinc (Placebo)

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TN2020-NAT-INS-38	Other Identifier	Tunisian Ministry of Health

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2020Estimated

Primary Completion Date

May 24, 2020Estimated

Completion Date

Jul 31, 2020Estimated

First Submitted Date

May 1, 2020

First Submission Date that Met QC Criteria

May 4, 2020

First Posted Date

May 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2020

Last Update Posted Date

May 6, 2020Actual

Name	Class
UR17DN02 : Autoimmune Diseases Research Unit	UNKNOWN
Dacima Consulting	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

660Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydroxychloroquine & Zinc	Active Comparator	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 Drug: Zinc
Hydroxychloroquine	Active Comparator	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 Drug: Zinc (Placebo)
Placebo	Placebo Comparator	Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months	Drug: Hydroxychloroquine (placebo) Drug: Zinc (Placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydroxychloroquine	Drug	400 mg at day 1 and day 2, then 400 mg weekly up to 2 months	Hydroxychloroquine Hydroxychloroquine & Zinc

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Faida Ajili, MD	Contact	+21698631188		faida1977@yahoo.fr
Neja Stambouli, PhD	Contact	+21655104234		nejlastam@gmail.com

Overall Officials

Name	Affiliation	Role
Faida Ajili, MD	Military Hospital of Tunis	Study Chair
Nejla Mrabet, PhD	Military Hospital of Tunis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Military Hospital of Tunis		Tunis			Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006886	Hydroxychloroquine
D015032	Zinc

Ancestor Terms

ID	Term
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided