Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:42 AM
Study NCT ID:
NCT04476706
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-02-03
First Post:
2020-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Canakinumab MAP in COVID-19 Pneumonia With CRS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D000080424', 'term': 'Cytokine Release Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541220', 'term': 'canakinumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['canakinumab', 'Ilaris', 'ACZ885', 'COVID-19', 'coronavirus', 'pneumonia', 'CRS', 'cytokine release syndrome'], 'conditions': ['Cytokine Release Syndrome in COVID-19-induced Pneumonia']}, 'descriptionModule': {'briefSummary': 'This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* 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);\n* Hospitalized with COVID-19-induced pneumonia;\n* Elevated CRP or ferritin levels;\n* Body weight ≥ 40kg.\n\nExclusion Criteria:\n\n* Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab;\n* 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);\n* Use of tocilizumab within 3 weeks prior to dosing with canakinumab;\n* Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19);\n* Patients with significant neutropenia (ANC \\<1000/mm3);\n* Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.'}, 'identificationModule': {'nctId': 'NCT04476706', 'briefTitle': 'Canakinumab MAP in COVID-19 Pneumonia With CRS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia', 'orgStudyIdInfo': {'id': 'CACZ885D2001M'}}, 'armsInterventionsModule': {'interventions': [{'name': 'canakinumab', 'type': 'DRUG', 'otherNames': ['Ilaris; ACZ885'], 'description': 'canakinumab'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}