This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia
Drug: canakinumab
canakinumab
Other Name: Ilaris; ACZ885
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.