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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351919
Recruitment Status : Withdrawn (- Interest in the use of HCQ is controversial.)
First Posted : April 17, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
Eshmoun Clinical Research Center
Dacima Consulting
Information provided by (Responsible Party):
Dr Jalila Ben Khelil, Abderrahmane Mami Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Patients With COVID19 Drug: Hydroxychloroquine Drug: Azithromycin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open, interventional, multicentric study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia
Estimated Study Start Date : May 5, 2020
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HCQ Arm Drug: Hydroxychloroquine
400mg per day during 10 days

Drug: Azithromycin
500 mg per day during 5 days


Outcome Measures
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Primary Outcome Measures :
  1. improvment or healing of clinical signs [ Time Frame: at the end of the study treatment - 1 month after inclusion ]
    no respiratory infectious signs

  2. Evolution of clinical signs [ Time Frame: at the end of the study treatment - 1 month after inclusion ]
    Low respiratory signs with severity criteria


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351919


Locations
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Tunisia
Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana
Tunis, Tunisia
Sponsors and Collaborators
Abderrahmane Mami Hospital
Eshmoun Clinical Research Center
Dacima Consulting
More Information
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Responsible Party: Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital
ClinicalTrials.gov Identifier: NCT04351919    
Other Study ID Numbers: ECC2020-04
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents