NCT04377646

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

20 days

First QC Date

May 1, 2020

Last Update Submit

May 4, 2020

Conditions

Sars-CoV2COVID19

Keywords

ProphylaxisZincHydroxychloroquineHealth ProfessionalsMilitary

Outcome Measures

Primary Outcomes (1)

  • SARS CoV2 infection

    Frequency of confirmed SARS CoV2 infection

    At 2 months of follow-up

Secondary Outcomes (2)

  • COVID-19 symptoms description

    At 2 months of follow-up

  • Adverse Events

    each month up to 2 months

Study Arms (3)

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: HydroxychloroquineDrug: 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: HydroxychloroquineDrug: Zinc (Placebo)

Placebo

PLACEBO COMPARATOR

Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months

Drug: Hydroxychloroquine (placebo)Drug: Zinc (Placebo)

Interventions

HydroxychloroquineDRUG

400 mg at day 1 and day 2, then 400 mg weekly up to 2 months

HydroxychloroquineHydroxychloroquine & Zinc
Hydroxychloroquine (placebo)DRUG

1 pill at day 1 and day 2, then 1 pill weekly up to 2 months

Placebo
ZincDRUG

15 mg per day up to 2 months

Hydroxychloroquine & Zinc
Zinc (Placebo)DRUG

1 pill per day up to 2 months

HydroxychloroquinePlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hospital of Tunis

Tunis, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Interventions

HydroxychloroquineZinc

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Faida Ajili, MD

    Military Hospital of Tunis

    STUDY CHAIR

  • Nejla Mrabet, PhD

    Military Hospital of Tunis

    STUDY DIRECTOR

Central Study Contacts

Faida Ajili, MD

CONTACT

+21698631188faida1977@yahoo.fr

Neja Stambouli, PhD

CONTACT

+21655104234nejlastam@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Random blind allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind randomized clinical trial with 3 arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 6, 2020

Study Start

May 4, 2020

Primary Completion

May 24, 2020

Study Completion

July 31, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)