Status:
COMPLETED
Canakinumab in Patients With COVID-19 and Type 2 Diabetes
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Novartis
Swiss National Science Foundation
Conditions:
Coronavirus Infection
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
Patients with a metabolic syndrome (overweight, diabetes, hypertension) have a particularly bad outcome if infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). This may be explai...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes mellitus
- Body mass index \> 25 kg/m² (overweight)
- Hospitalized with COVID-19
Exclusion
- 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-
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2021
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04510493
Start Date
October 23 2020
End Date
August 17 2021
Last Update
September 8 2021
Active Locations (9)
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1
University Medical Clinic Aarau
Aarau, Switzerland, 5001
2
University Hospital Basel
Basel, Switzerland, 4031
3
University Hospital Bern
Bern, Switzerland, 3010
4
Hopital du Jura
Delémont, Switzerland, 2800