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:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT04510493
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 2 diabetes mellitus
* Body mass index \> 25 kg/m² (overweight)
* Hospitalized with COVID-19
Exclusion Criteria:
* Suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of COVID-19
* Treatment with immunomodulators or immunosuppressant drugs, including but not limited to tocilizumab, tumor necrosis factor (TNF) inhibitors and anti-IL-17 agents within 5 half-lives or 30 days (whichever is longer) prior to randomization with the exception of anakinra which is excluded within 5 half-lives only. Note: Immunomodulators (topical or inhaled) for asthma and atopic dermatitis, and corticosteroids (any route of administration) such as dexamethasone are permitted.
* History of hypersensitivity to canakinumab or to biologic drugs
* Neutrophil count \<1000/mm3
* Pregnant or nursing (lactating) women
* Participation in another study with investigational drug within the 30 days preceding and during the present study-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04510493
Study Brief:
Protocol Section:
NCT04510493