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Canakinumab MAP in COVID-19 Pneumonia With CRS


Study First Submitted Date 2020-07-16
Study First Posted Date 2020-07-20
Last Update Posted Date 2021-02-03
Verification Month Year January 2021
Verification Date 2021-01-31
Last Update Posted Date 2021-02-03


Sequence: 52192027
Name Cytokine Release Syndrome in COVID-19-induced Pneumonia
Downcase Name cytokine release syndrome in covid-19-induced pneumonia

Id Information

Sequence: 40174136
Id Source org_study_id
Id Value CACZ885D2001M


Sequence: 52506234
Intervention Type Drug
Name canakinumab
Description canakinumab


Sequence: 79898945 Sequence: 79898946 Sequence: 79898947 Sequence: 79898948 Sequence: 79898949 Sequence: 79898950 Sequence: 79898951 Sequence: 79898952
Name canakinumab Name Ilaris Name ACZ885 Name COVID-19 Name coronavirus Name pneumonia Name CRS Name cytokine release syndrome
Downcase Name canakinumab Downcase Name ilaris Downcase Name acz885 Downcase Name covid-19 Downcase Name coronavirus Downcase Name pneumonia Downcase Name crs Downcase Name cytokine release syndrome

Browse Conditions

Sequence: 193565518 Sequence: 193565519 Sequence: 193565520 Sequence: 193565521 Sequence: 193565522 Sequence: 193565523 Sequence: 193565524 Sequence: 193565525 Sequence: 193565526 Sequence: 193565527 Sequence: 193565528 Sequence: 193565529 Sequence: 193565530 Sequence: 193565531 Sequence: 193565532 Sequence: 193565533 Sequence: 193565534 Sequence: 193565535 Sequence: 193565536
Mesh Term COVID-19 Mesh Term Pneumonia Mesh Term Syndrome Mesh Term Cytokine Release Syndrome Mesh Term Disease Mesh Term Pathologic Processes Mesh Term Pneumonia, Viral Mesh Term Respiratory Tract Infections Mesh Term Infections Mesh Term Virus Diseases Mesh Term Coronavirus Infections Mesh Term Coronaviridae Infections Mesh Term Nidovirales Infections Mesh Term RNA Virus Infections Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases Mesh Term Systemic Inflammatory Response Syndrome Mesh Term Inflammation Mesh Term Shock
Downcase Mesh Term covid-19 Downcase Mesh Term pneumonia Downcase Mesh Term syndrome Downcase Mesh Term cytokine release syndrome Downcase Mesh Term disease Downcase Mesh Term pathologic processes Downcase Mesh Term pneumonia, viral Downcase Mesh Term respiratory tract infections Downcase Mesh Term infections Downcase Mesh Term virus diseases Downcase Mesh Term coronavirus infections Downcase Mesh Term coronaviridae infections Downcase Mesh Term nidovirales infections Downcase Mesh Term rna virus infections Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term systemic inflammatory response syndrome Downcase Mesh Term inflammation Downcase Mesh Term shock
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48338614
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Novartis Pharmaceuticals


Sequence: 30777577
Gender All
Minimum Age 18 Years
Maximum Age 100 Years
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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253968455
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 100
Minimum Age Unit Years
Maximum Age Unit Years

Intervention Other Names

Sequence: 26683405
Intervention Id 52506234
Name Ilaris; ACZ885

Responsible Parties

Sequence: 28890012
Responsible Party Type Sponsor