NCT04351919

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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

May 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

April 15, 2020

Last Update Submit

August 26, 2020

Conditions

Patients With COVID19

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

HCQ Arm

EXPERIMENTAL
Drug: HydroxychloroquineDrug: Azithromycin

Interventions

HydroxychloroquineDRUG

400mg per day during 10 days

HCQ Arm
AzithromycinDRUG

500 mg per day during 5 days

HCQ Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana

Tunis, Tunisia

Location

MeSH Terms

Interventions

HydroxychloroquineAzithromycin

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open, interventional, multicentric study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

May 5, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations

TU(1)