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).
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 explained by an over-activation of the Interleukin-1 (IL-1) beta system.
Metabolic stress (increased glucose and lipid levels) induces NOD-, LRR- and pyrin
domain-containing protein 3 (NLRP3) -mediated IL-1beta secretion. SARS-CoV2 also activates
NLRP3. Therefore, the study proposes that metabolic stress in patients with overweight and
diabetes potentiates COVID-19 induced hyperinflammatory syndrome leading to excess mortality
in these vulnerable patients. Canakinumab (Ilaris®) is a recombinant, human monoclonal
antibody antagonizing IL-1beta by blocking IL-1beta activity. The aim of the study is to
investigate the effect of canakinumab in type 2 diabetic patients with COVID-19.
Drug: Canakinumab
Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours
Other Name: Ilaris®
Drug: Placebo
Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours
Other Name: Aqua ad injectabilia in 250 ml 5% dextrose solution
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-
University Medical Clinic Aarau
Aarau, Switzerland
University Hospital Basel
Basel, Switzerland
University Hospital Bern
Bern, Switzerland
Hopital du Jura
Delémont, Switzerland
University Hospital Geneva
Geneva, Switzerland
University Hospital Lausanne
Lausanne, Switzerland
Cantonal Hospital Lucerne
Luzern, Switzerland
Cantonal Hospital St Gallen
St. Gallen, Switzerland
University Hospital Zürich
Zürich, Switzerland
Marc Donath, MD, Prof., Principal Investigator
University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism