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

NCT ID: NCT04351919

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2020-07-15

Brief Summary

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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

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Conditions

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Patients With COVID19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open, interventional, multicentric study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCQ Arm

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

400mg per day during 10 days

Azithromycin

Intervention Type DRUG

500 mg per day during 5 days

Interventions

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Hydroxychloroquine

400mg per day during 10 days

Intervention Type DRUG

Azithromycin

500 mg per day during 5 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eshmoun Clinical Research Center

NETWORK

Sponsor Role collaborator

Dacima Consulting

OTHER

Sponsor Role collaborator

Abderrahmane Mami Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Jalila Ben Khelil

Head of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana

Tunis, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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ECC2020-04

Identifier Type: -

Identifier Source: org_study_id

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