Assessment of Efficacy and Safety of HCQ and Antibiotics... | NCT04351919

Studies
Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)

NCT04351919

Sponsor

Abderrahmane Mami Hospital

Status

Withdrawn

Last Update Posted

Aug 28, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Patients With COVID19

Interventions

Hydroxychloroquine
Azithromycin

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

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

- Interest in the use of HCQ is controversial.

Expanded Access Info

Start Date

May 5, 2020Estimated

Primary Completion Date

Jul 15, 2020Estimated

Completion Date

Jul 15, 2020Estimated

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 17, 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

Aug 26, 2020

Last Update Posted Date

Aug 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami HospitalPrincipal Investigator

Lead Sponsor

Abderrahmane Mami HospitalOTHER

Collaborators

Name	Class
Eshmoun Clinical Research Center	NETWORK
Dacima Consulting	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The study will assess the number of patients who become asymptomatic from clinical signs of COVID19 and will assess the efficacy of Hydroxychloroquine (HCQ) and Azithromycine effects on paucisymptomatic patients with ou without co-morbidities

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCQ Arm	Experimental		Drug: Hydroxychloroquine Drug: Azithromycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydroxychloroquine	Drug	400mg per day during 10 days	HCQ Arm
Azithromycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvment or healing of clinical signs	no respiratory infectious signs	at the end of the study treatment - 1 month after inclusion
Evolution of clinical signs	Low respiratory signs with severity criteria	at the end of the study treatment - 1 month after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

confirmed COVID19 (+)
Qt<500ms
no severity criteria
pauci-symptomatique patients
signed consent form

Exclusion Criteria:

no confirmed patient COVID19
severity criteria
known allegies to macrolides and HCQ
Treated with HCQ within 1 month prior to inclusion
hepatitis insufficiency
Renal insufficiency
treatment no indicated with azithro and HCQ
hypovolemia
complete brach block
retinopathia
psoriasis
pregnancy or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana		Tunis			Tunisia

Intervention Browse Module

MeSH Terms

ID	Term
D006886	Hydroxychloroquine
D017963	Azithromycin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided