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EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA (TEACHCOVID)

Primary Purpose

Sars-CoV-2, Community-Acquired Pneumonia,COVID-19

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine and azithromycin treatment arm.
Hydroxychloroquine
Control arm
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sars-CoV-2, Community-Acquired Pneumonia,COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years old
  • Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab
  • CT scan suggestive of Sars-CoV-2 pneumonia

Exclusion Criteria:

  • Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab
  • Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family member
  • Long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin)
  • Retinopathy or maculopathy
  • Porphyria
  • Severe renal failure (GFR less than 30 mL/min/m²)
  • Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L)
  • Hypomagnesiemia, ie less than 0,7 mmol/L
  • Severe cholestasis, cirrhosis or severe hepatic failure
  • Known cardiac medical history of congestive heart failure or myocardial infarction
  • Bradycardia less than 50 beats per minute
  • Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders
  • Blood disorders with history of hematopoietic stem cells allograft
  • Known history of G6PD deficiency
  • Pregnancy
  • Breastfeeding
  • Subject protected by law under guardianship of curatorship
  • Inability to take oral medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Hydroxychloroquine

    Control

    Hydroxychloroquine and Azithromycin

    Arm Description

    Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5). Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc)

    The patient is given antibiotics only. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc).

    Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5). Azithromycin is given for 5 days, with a loading dose of 500 mg at D1, and 250 mg for the next 4 days. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc) In case of moderate renal failure (glomerular filtration rate between 30 and 60 mL/min/m²), hydroxychloroquine dosage are lowered by half.

    Outcomes

    Primary Outcome Measures

    Rate of patients reaching a significant hypoxemia, in each arms.
    A significant hypoxemia is an arterial partial pressure of oxygen of less than 60 mmHg despite an oxygen flow of more than 6 L/min, patient at rest.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2020
    Last Updated
    June 2, 2020
    Sponsor
    University Hospital, Strasbourg, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04347512
    Brief Title
    EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
    Acronym
    TEACHCOVID
    Official Title
    EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    In view of the notices concerning hydroxychloroquine issued by the regulatory authorities, we withdraw the protocol
    Study Start Date
    June 2, 2020 (Actual)
    Primary Completion Date
    June 2, 2020 (Actual)
    Study Completion Date
    June 2, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Strasbourg, France

    4. Oversight

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

    5. Study Description

    Brief Summary
    Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sars-CoV-2, Community-Acquired Pneumonia,COVID-19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydroxychloroquine
    Arm Type
    Experimental
    Arm Description
    Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5). Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc)
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The patient is given antibiotics only. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc).
    Arm Title
    Hydroxychloroquine and Azithromycin
    Arm Type
    Experimental
    Arm Description
    Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5). Azithromycin is given for 5 days, with a loading dose of 500 mg at D1, and 250 mg for the next 4 days. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc) In case of moderate renal failure (glomerular filtration rate between 30 and 60 mL/min/m²), hydroxychloroquine dosage are lowered by half.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxychloroquine and azithromycin treatment arm.
    Intervention Description
    Patient allocated in this arm receive hydroxychloroquine and azithromycin for 5 days. For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5. For azithromycin, there is a loading dose of 500 mg per day at D1, followed by 250 mg per day D2-D5. Every patient receive as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxychloroquine
    Intervention Description
    Patient allocated in this arm receive hydroxychloroquine for 5 days. For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5. Every patient receives as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
    Intervention Type
    Drug
    Intervention Name(s)
    Control arm
    Intervention Description
    In this arm, no experimental treatment is prescribed. Patients receive IV antibiotics and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
    Primary Outcome Measure Information:
    Title
    Rate of patients reaching a significant hypoxemia, in each arms.
    Description
    A significant hypoxemia is an arterial partial pressure of oxygen of less than 60 mmHg despite an oxygen flow of more than 6 L/min, patient at rest.
    Time Frame
    From day 0 to day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years old Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab CT scan suggestive of Sars-CoV-2 pneumonia Exclusion Criteria: Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family member Long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin) Retinopathy or maculopathy Porphyria Severe renal failure (GFR less than 30 mL/min/m²) Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L) Hypomagnesiemia, ie less than 0,7 mmol/L Severe cholestasis, cirrhosis or severe hepatic failure Known cardiac medical history of congestive heart failure or myocardial infarction Bradycardia less than 50 beats per minute Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders Blood disorders with history of hematopoietic stem cells allograft Known history of G6PD deficiency Pregnancy Breastfeeding Subject protected by law under guardianship of curatorship Inability to take oral medications

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA

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