<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04476706</url>
  </required_header>
  <id_info>
    <org_study_id>CACZ885D2001M</org_study_id>
    <nct_id>NCT04476706</nct_id>
  </id_info>
  <brief_title>Canakinumab MAP in COVID-19 Pneumonia With CRS</brief_title>
  <official_title>Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <brief_summary>
    <textblock>
      This is a global Managed Access Program (MAP) to provide access to canakinumab to patients&#xD;
      with cytokine release syndrome resulting from COVID-19 pneumonia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <condition>Cytokine Release Syndrome in COVID-19-induced Pneumonia</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>canakinumab</intervention_name>
    <description>canakinumab</description>
    <other_name>Ilaris; ACZ885</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old;&#xD;
&#xD;
          -  Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic&#xD;
             methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes&#xD;
             ruled out and COVID-19 test pending);&#xD;
&#xD;
          -  Hospitalized with COVID-19-induced pneumonia;&#xD;
&#xD;
          -  Elevated CRP or ferritin levels;&#xD;
&#xD;
          -  Body weight ≥ 40kg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eligible patients must not have a history of hypersensitivity to any drugs or&#xD;
             metabolites of similar chemical classes as canakinumab;&#xD;
&#xD;
          -  On the day of canakinumab treatment initiation; treatment with biologic&#xD;
             immunomodulators or immunosuppressant drugs, including but not limited to TNF&#xD;
             inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and&#xD;
             atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg&#xD;
             prednisone per day);&#xD;
&#xD;
          -  Use of tocilizumab within 3 weeks prior to dosing with canakinumab;&#xD;
&#xD;
          -  Suspected or known active bacterial, fungal, or parasitic infection (besides&#xD;
             COVID-19);&#xD;
&#xD;
          -  Patients with significant neutropenia (ANC &lt;1000/mm3);&#xD;
&#xD;
          -  Treatment with an investigational drug within 5 half-lives or 30 days (whichever is&#xD;
             longer) prior to canakinumab dose.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>canakinumab</keyword>
  <keyword>Ilaris</keyword>
  <keyword>ACZ885</keyword>
  <keyword>COVID-19</keyword>
  <keyword>coronavirus</keyword>
  <keyword>pneumonia</keyword>
  <keyword>CRS</keyword>
  <keyword>cytokine release syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Cytokine Release Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04476706
org study id: CACZ885D2001M
nct id: NCT04476706
lead sponsor: 
This is a global Managed Access Program (MAP) to provide access to canakinumab to patients
      with cytokine release syndrome resulting from COVID-19 pneumonia
intervention type: Drug
intervention name: canakinumab
description: canakinumab
other name: Ilaris; ACZ885
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Syndrome
mesh term: Cytokine Release Syndrome