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

No longer available
Cytokine Release Syndrome in COVID-19-induced Pneumonia

Drug: canakinumab
canakinumab
Other Name: Ilaris; ACZ885

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 100 Years
Novartis Pharmaceuticals
NCT Number
Keywords
canakinumab
Ilaris
ACZ885
Covid-19
Coronavirus
Pneumonia
CRS
cytokine release syndrome
MeSH Terms
Pneumonia
Syndrome
Intervention Name
canakinumab