NCT04510493

Canakinumab in Patients With COVID-19 and Type 2 Diabetes

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Coronavirus Infection
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Canakinumab	Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours
DRUG	Placebo	Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours

Timeline

• Start date: 2020-10-23
• Primary completion: 2021-08-17
• Completion: 2021-08-17
• First posted: 2020-08-12
• Last updated: 2021-09-08

Locations

9 sites across 1 country: Switzerland