FindTrial
Sign In

Canakinumab MAP in COVID-19 Pneumonia With CRS

Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04476706
Enrollment
Unknown
Registered
2020-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytokine Release Syndrome in COVID-19-induced Pneumonia

Keywords

canakinumab, Ilaris, ACZ885, COVID-19, coronavirus, pneumonia, CRS, cytokine release syndrome

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

Interventions

DRUGcanakinumab

canakinumab

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026