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Canakinumab MAP in COVID-19 Pneumonia With CRS

Primary Purpose

Cytokine Release Syndrome in COVID-19-induced Pneumonia

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
canakinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Cytokine Release Syndrome in COVID-19-induced Pneumonia focused on measuring canakinumab, Ilaris, ACZ885, COVID-19, coronavirus, pneumonia, CRS, cytokine release syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old;
  • Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending);
  • Hospitalized with COVID-19-induced pneumonia;
  • Elevated CRP or ferritin levels;
  • Body weight ≥ 40kg.

Exclusion Criteria:

  • Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab;
  • On the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day);
  • Use of tocilizumab within 3 weeks prior to dosing with canakinumab;
  • Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19);
  • Patients with significant neutropenia (ANC <1000/mm3);
  • Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 16, 2020
    Last Updated
    February 1, 2021
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04476706
    Brief Title
    Canakinumab MAP in COVID-19 Pneumonia With CRS
    Official Title
    Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cytokine Release Syndrome in COVID-19-induced Pneumonia
    Keywords
    canakinumab, Ilaris, ACZ885, COVID-19, coronavirus, pneumonia, CRS, cytokine release syndrome

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    canakinumab
    Other Intervention Name(s)
    Ilaris; ACZ885
    Intervention Description
    canakinumab

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years old; Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending); Hospitalized with COVID-19-induced pneumonia; Elevated CRP or ferritin levels; Body weight ≥ 40kg. Exclusion Criteria: Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; On the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day); Use of tocilizumab within 3 weeks prior to dosing with canakinumab; Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19); Patients with significant neutropenia (ANC <1000/mm3); Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.

    12. IPD Sharing Statement

    Learn more about this trial

    Canakinumab MAP in COVID-19 Pneumonia With CRS

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