Status:
NO_LONGER_AVAILABLE
Canakinumab MAP in COVID-19 Pneumonia With CRS
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cytokine Release Syndrome in COVID-19-induced Pneumonia
Eligibility:
All Genders
18-100 years
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04476706
Last Update
February 3 2021
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