Canakinumab in Patients With COVID-19 and Type 2 Diabetes (CanCovDia)

University Hospital Basel

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Coronavirus Infection

Treatments

Drug: Placebo

Drug: Canakinumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04510493

2020-02008 me20Donath2;

Details and patient eligibility

About

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).

Full 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 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.

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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-