Studies
| 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 |
Conditions
| 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 |
Interventions
| Sequence: | 52506234 |
| Intervention Type | Drug |
| Name | canakinumab |
| Description | canakinumab |
Keywords
| 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 |
Sponsors
| Sequence: | 48338614 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Novartis Pharmaceuticals |
Eligibilities
| 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 |