Canakinumab MAP in COVID-19 Pneumonia With CRS

Novartis

Status

Conditions: Cytokine Release Syndrome in COVID-19-induced Pneumonia

Treatments: Drug: canakinumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04476706

CACZ885D2001M

Details and patient eligibility

About

This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.