Canakinumab MAP in COVID-19 Pneumonia With CRS

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

No longer available

CT.gov ID

NCT04476706

Collaborator

(none)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cytokine Release Syndrome in COVID-19-induced Pneumonia	Drug: canakinumab

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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.