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Canakinumab MAP in COVID-19 Pneumonia With CRS

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ClinicalTrials.gov Identifier: NCT04476706
Expanded Access Status : Available
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment
Cytokine Release Syndrome in COVID-19-induced Pneumonia Drug: canakinumab

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Canakinumab


Intervention Details:
  • Drug: canakinumab
    canakinumab
    Other Name: Ilaris; ACZ885

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04476706


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04476706    
Other Study ID Numbers: CACZ885D2001M
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
canakinumab
Ilaris
ACZ885
COVID-19
coronavirus
pneumonia
CRS
cytokine release syndrome
Additional relevant MeSH terms:
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Pneumonia
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections