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

August 26, 2020 updated by: Dr Jalila Ben Khelil, Abderrahmane Mami Hospital

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCQ Arm
Drug: Hydroxychloroquine
400mg per day during 10 days
Drug: Azithromycin
500 mg per day during 5 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abderrahmane Mami Hospital

Collaborators

Dacima Consulting
Eshmoun Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 5, 2020

Primary Completion (Anticipated)

July 15, 2020

Study Completion (Anticipated)

July 15, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECC2020-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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