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

Primary Purpose

Patients With COVID19

Status
Withdrawn
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Sponsored by
Abderrahmane Mami Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With COVID19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCQ Arm

Arm Description

Outcomes

Primary Outcome Measures

improvment or healing of clinical signs
no respiratory infectious signs
Evolution of clinical signs
Low respiratory signs with severity criteria

Secondary Outcome Measures

Full Information

First Posted
April 15, 2020
Last Updated
August 26, 2020
Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Dacima Consulting
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1. Study Identification

Unique Protocol Identification Number
NCT04351919
Brief Title
Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)
Acronym
COVID+PA
Official Title
Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
- Interest in the use of HCQ is controversial.
Study Start Date
May 5, 2020 (Anticipated)
Primary Completion Date
July 15, 2020 (Anticipated)
Study Completion Date
July 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Dacima Consulting

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With COVID19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
open, interventional, multicentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCQ Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
400mg per day during 10 days
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
500 mg per day during 5 days
Primary Outcome Measure Information:
Title
improvment or healing of clinical signs
Description
no respiratory infectious signs
Time Frame
at the end of the study treatment - 1 month after inclusion
Title
Evolution of clinical signs
Description
Low respiratory signs with severity criteria
Time Frame
at the end of the study treatment - 1 month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana
City
Tunis
Country
Tunisia

12. IPD Sharing Statement

Learn more about this trial

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

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