NCT04476706No Longer AvailableNot Applicable
Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- No Longer Available
- Sponsor
- Novartis Pharmaceuticals
Study Overview
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
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
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