Canakinumab in Patients With COVID-19 and Type 2 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 112
Summary
- Conditions
- Coronavirus Infection
- Diabetes Mellitus - Type 2
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 gluco...
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.
Tracking Information
- NCT #
- NCT04510493
- Collaborators
- Novartis
- Swiss National Science Foundation
- Investigators
- Principal Investigator: Marc Donath, MD, Prof. University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
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