Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT04476706
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04476706
Study Brief:
Protocol Section:
NCT04476706