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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Swiss National Science Foundation | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment arm | Active Comparator | Treatment with Canakinumab i.v. administered over 2 hours |
|
| placebo treatment arm | Placebo Comparator | placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canakinumab | Drug | Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint) | 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):
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. | within 4 weeks after treatment with canakinumab or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical improvement | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Donath, MD, Prof. | University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Clinic Aarau | Aarau | 5001 | Switzerland | |||
| University Hospital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36128334 | Derived | Hepprich M, Mudry JM, Gregoriano C, Jornayvaz FR, Carballo S, Wojtusciszyn A, Bart PA, Chiche JD, Fischli S, Baumgartner T, Cavelti-Weder C, Braun DL, Gunthard HF, Beuschlein F, Conen A, West E, Isenring E, Zechmann S, Bucklar G, Aubry Y, Dey L, Muller B, Hunziker P, Schutz P, Cattaneo M, Donath MY. Canakinumab in patients with COVID-19 and type 2 diabetes - A multicentre, randomised, double-blind, placebo-controlled trial. EClinicalMedicine. 2022 Sep 17;53:101649. doi: 10.1016/j.eclinm.2022.101649. eCollection 2022 Nov. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D003924 | Diabetes Mellitus, Type 2 |
| D000086382 | COVID-19 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
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| Placebo | Drug | Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours |
|
|
| From randomization up to 4 weeks |
| Death rate | Death rate during the 4-week period after study treatment | 4 weeks |
| Admission to intensive care unit (ICU) | Admission to the intensive care unit from the medical ward during the 4-week period after study treatment | 4 weeks |
| Secondary worsening of disease | Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment) | 4 weeks |
| Prolonged hospital stay | Prolonged hospital stay > 3 weeks | >3 weeks |
| Change in ratio to baseline in the glycated hemoglobin | Ratio to baseline in the glycated hemoglobin | Baseline, Day 29 and Day 90 |
| Change in ratio to baseline in the fasting glucose | Ratio to baseline in the fasting glucose | Baseline, Day 29 |
| Change in ratio to baseline in the fasting insulin | Ratio to baseline in the fasting insulin | Baseline, Day 29 |
| Change in ratio to baseline in the fasting c-peptide | Ratio to baseline in the fasting c-peptide | Baseline, Day 29 |
| Ratio to baseline in the C-reactive protein (CRP) | Ratio to baseline in the C-reactive protein (CRP) | Baseline, Day 29 and Day 90 |
| Change in ratio to baseline in the D-dimer | Ratio to baseline in the D-dimer | Baseline, Day 29 |
| Change in ratio to baseline in the Natriuretic peptide (NTproBNP) | Ratio to baseline in the Natriuretic peptide (NTproBNP) | Baseline, Day 29 and Day 90 |
| Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR) | Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR) | Baseline, Day 29 and Day 90 |
| Type of antidiabetic treatment at Day 29 | Type of antidiabetic treatment at Day 29 | Day 29 |
| Number of antidiabetic treatment at Day 29 | Number of antidiabetic treatment at Day 29 | Day 29 |
| Type of antidiabetic treatment at three months | Type of antidiabetic treatment at three months | Month 3 |
| Number of antidiabetic treatment at three months | Number of antidiabetic treatment at three months | Month 3 |
| Basel |
| 4031 |
| Switzerland |
| University Hospital Bern | Bern | 3010 | Switzerland |
| Hopital du Jura | Delémont | 2800 | Switzerland |
| University Hospital Geneva | Geneva | 1205 | Switzerland |
| University Hospital Lausanne | Lausanne | 1011 | Switzerland |
| Cantonal Hospital Lucerne | Lucerne | 6004 | Switzerland |
| Cantonal Hospital St Gallen | Sankt Gallen | 9001 | Switzerland |
| University Hospital Zürich | Zurich | 8091 | Switzerland |
| D007239 |
| Infections |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |