Canakinumab in Patients With COVID-19 and Type 2 Diabetes

• Status: Completed
• Trial end date: 2021-08-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Novartis; Swiss National Science Foundation

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-