Canakinumab MAP in COVID-19 Pneumonia With CRS

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

• Registration Number: NCT04476706
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified