Canakinumab in Patients With COVID-19 and Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-23

Study Completion Date

2021-08-17

Brief Summary

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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).

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Detailed Description

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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

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Coronavirus Infection Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active treatment arm

Treatment with Canakinumab i.v. administered over 2 hours

Group Type ACTIVE_COMPARATOR

Canakinumab

Intervention Type DRUG

Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours

placebo treatment arm

placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours

Interventions

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Canakinumab

Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours

Intervention Type DRUG

Placebo

Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours

Intervention Type DRUG

Other Intervention Names

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Ilaris® Aqua ad injectabilia in 250 ml 5% dextrose solution

Eligibility Criteria

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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-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No