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Completed

NCT Number: NCT04510493

Canakinumab in Patients With COVID-19 and Type 2 Diabetes

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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Key information

Conditions

Coronavirus Infection Body Weight COVID-19 Coronaviridae Infections Coronavirus Infections Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Clinic Aarau, Aarau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

Canakinumab

Drug

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

Other names: Ilaris®

Placebo

Drug

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

Other names: Aqua ad injectabilia in 250 ml 5% dextrose solution

Primary outcomes

  1. unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint)

    Time frame: within 4 weeks after treatment with canakinumab or placebo

    Treatment and placebo will be compared on the basis of the unmatched win-ratio approach of Pocock. When comparing two patients, the winner will be determined by the first component in which the two patients differ (4 weeks after randomization):

    • longer survival time
    • longer ventilation-free time
    • longer ICU-free time
    • shorter hospitalization time

    If there is no difference between treatment and Placebo: the win ratio is 1. If there is a difference between treatment and Placebo: the win ratio is not 1.

Secondary outcomes

  1. Time to clinical improvement

    Time frame: From randomization up to 4 weeks

    Time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever comes first. "The seven-category ordinal scale consists of the following categories:

    • not hospitalized with resumption of normal activities;
    • not hospitalized, but unable to resume normal activities;
    • hospitalized, not requiring supplemental oxygen;
    • hospitalized, requiring supplemental oxygen;
    • hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both;
    • hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and
    • death"

  2. Death rate

    Time frame: 4 weeks

    Death rate during the 4-week period after study treatment

  3. Admission to intensive care unit (ICU)

    Time frame: 4 weeks

    Admission to the intensive care unit from the medical ward during the 4-week period after study treatment

  4. Secondary worsening of disease

    Time frame: 4 weeks

    Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment)

  5. Prolonged hospital stay

    Time frame: >3 weeks

    Prolonged hospital stay > 3 weeks

  6. Change in ratio to baseline in the glycated hemoglobin

    Time frame: Baseline, Day 29 and Day 90

    Ratio to baseline in the glycated hemoglobin

  7. Change in ratio to baseline in the fasting glucose

    Time frame: Baseline, Day 29

    Ratio to baseline in the fasting glucose

  8. Change in ratio to baseline in the fasting insulin

    Time frame: Baseline, Day 29

    Ratio to baseline in the fasting insulin

  9. Change in ratio to baseline in the fasting c-peptide

    Time frame: Baseline, Day 29

    Ratio to baseline in the fasting c-peptide

  10. Ratio to baseline in the C-reactive protein (CRP)

    Time frame: Baseline, Day 29 and Day 90

    Ratio to baseline in the C-reactive protein (CRP)

  11. Change in ratio to baseline in the D-dimer

    Time frame: Baseline, Day 29

    Ratio to baseline in the D-dimer

  12. Change in ratio to baseline in the Natriuretic peptide (NTproBNP)

    Time frame: Baseline, Day 29 and Day 90

    Ratio to baseline in the Natriuretic peptide (NTproBNP)

  13. Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

    Time frame: Baseline, Day 29 and Day 90

    Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

  14. Type of antidiabetic treatment at Day 29

    Time frame: Day 29

    Type of antidiabetic treatment at Day 29

  15. Number of antidiabetic treatment at Day 29

    Time frame: Day 29

    Number of antidiabetic treatment at Day 29

  16. Type of antidiabetic treatment at three months

    Time frame: Month 3

    Type of antidiabetic treatment at three months

  17. Number of antidiabetic treatment at three months

    Time frame: Month 3

    Number of antidiabetic treatment at three months

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Novartis
  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: CanCovDia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2020
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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