Canakinumab MAP in COVID-19 Pneumonia With CRS

Cytokine Release Syndrome in COVID-19-induced Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04476706
• Other study ID #: CACZ885D2001M
• Status: No longer available

Study information

• Verified date: January 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cytokine Release Syndrome in COVID-19-induced Pneumonia
• Pneumonia
• Syndrome

Intervention

Drug:
• canakinumab
canakinumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals