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The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Imatinib Mesylate
Standard of Care
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Pneumonia, ARDS, Cytokine Storm

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with PCR positive for SARS-COV-2
  • Hospitalized with moderate to severe respiratory symptoms as assessed by the Egyptian Ministry of Health National Guidelines
  • Informed consent explained & signed by patient or his 1st degree relatives or legally authorized representative.

Exclusion Criteria:

  • Pregnant women (or) breast feeding women
  • Patients younger than 18 years of age
  • Patients with known allergy to imatinib
  • Total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN).
  • Creatinine clearance (CrCl) < 30 mL/minute.
  • Patient already on mechanical ventilation at time of screening.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Imatinib Standard Dose

    Imatinib Low Dose

    Control

    Arm Description

    Imatinib 400 mg oral tablet once daily for 21 days In addition for the treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).

    Imatinib 200 mg oral tablet once daily for 21 days. In addition to the treatment for COVID-19 Pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).

    Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).

    Outcomes

    Primary Outcome Measures

    Primary endpoint: Disease Progression
    Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.

    Secondary Outcome Measures

    Improvement in Hypoxic Index
    Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
    Hospital Length of Stay
    Hospital Length of stay
    Days on invasive mechanical ventilation
    Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation
    Inflammatory Markers
    Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups
    Viral clearance
    Rate of viral clearance as monitored by SARS-COV-2 PCR
    Radiological assessment
    Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)
    Safety of Imatinib
    Rate of serious adverse events (SAEs)

    Full Information

    First Posted
    June 5, 2020
    Last Updated
    June 8, 2020
    Sponsor
    Alexandria University
    Collaborators
    Science, Technology & Innovation Funding Authority (STIFA), Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04422678
    Brief Title
    The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia
    Official Title
    Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    October 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alexandria University
    Collaborators
    Science, Technology & Innovation Funding Authority (STIFA), Egypt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A randomized controlled pilot study on the safety & efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia.
    Detailed Description
    As the coronavirus disease (COVID-19) spreads worldwide, awaiting the development of a vaccine, researchers are looking among the arsenal of available drugs, for a potential cure or medication to improve patients' outcome. A highly elevated levels of cytokines in COVID-19 patients requiring ICU admission, has suggested that a "cytokine storm" was associated with disease severity. Data from cellular, animal models and clinical trials, showed a beneficial role of tyrosine kinase inhibitors in the regulation of inflammation, the maintenance of endothelial barrier integrity, as well as the expression of antiviral properties. This data is especially derived from imatinib, the most studied Abl family kinase inhibitor, that is currently in clinical use for multiple medical conditions. Based on this encouraging data, we hypothesize that imatinib might be beneficial for the treatment of patients with SARS-CoV-2 pneumonia, in the aim of preventing disease progression into the severe phenotype of hypoxic respiratory failure and acute respiratory distress syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    SARS-CoV-2, Pneumonia, ARDS, Cytokine Storm

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Imatinib Standard Dose
    Arm Type
    Experimental
    Arm Description
    Imatinib 400 mg oral tablet once daily for 21 days In addition for the treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
    Arm Title
    Imatinib Low Dose
    Arm Type
    Experimental
    Arm Description
    Imatinib 200 mg oral tablet once daily for 21 days. In addition to the treatment for COVID-19 Pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
    Intervention Type
    Drug
    Intervention Name(s)
    Imatinib Mesylate
    Other Intervention Name(s)
    Imatinib
    Intervention Description
    Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.
    Intervention Type
    Drug
    Intervention Name(s)
    Standard of Care
    Other Intervention Name(s)
    Standard
    Intervention Description
    Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.
    Primary Outcome Measure Information:
    Title
    Primary endpoint: Disease Progression
    Description
    Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
    Time Frame
    30 Days
    Secondary Outcome Measure Information:
    Title
    Improvement in Hypoxic Index
    Description
    Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
    Time Frame
    From inclusion to 30 days follow up
    Title
    Hospital Length of Stay
    Description
    Hospital Length of stay
    Time Frame
    From inclusion to 30 days follow up
    Title
    Days on invasive mechanical ventilation
    Description
    Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation
    Time Frame
    From inclusion to 30 days follow up
    Title
    Inflammatory Markers
    Description
    Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups
    Time Frame
    From inclusion to 30 days
    Title
    Viral clearance
    Description
    Rate of viral clearance as monitored by SARS-COV-2 PCR
    Time Frame
    From inclusion to 30 days
    Title
    Radiological assessment
    Description
    Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)
    Time Frame
    From inclusion to 30 days
    Title
    Safety of Imatinib
    Description
    Rate of serious adverse events (SAEs)
    Time Frame
    From inclusion to 60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with PCR positive for SARS-COV-2 Hospitalized with moderate to severe respiratory symptoms as assessed by the Egyptian Ministry of Health National Guidelines Informed consent explained & signed by patient or his 1st degree relatives or legally authorized representative. Exclusion Criteria: Pregnant women (or) breast feeding women Patients younger than 18 years of age Patients with known allergy to imatinib Total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN). Creatinine clearance (CrCl) < 30 mL/minute. Patient already on mechanical ventilation at time of screening.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ASSAAD, MD, PhD
    Phone
    00201223125575
    Email
    samir.assaadkhalil@alexmed.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hany ASSAAD, MD, PhD
    Organizational Affiliation
    University of Alexandria
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia

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