Canakinumab in Patients With COVID-19 and Type 2 Diabetes (CanCovDia)
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ClinicalTrials.gov Identifier: NCT04510493 |
Recruitment Status :
Completed
First Posted : August 12, 2020
Last Update Posted : September 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Infection Diabetes Mellitus, Type 2 | Drug: Canakinumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Canakinumab in Patients With COVID-19 and Type 2 Diabetes - CanCovDia Trial |
Actual Study Start Date : | October 23, 2020 |
Actual Primary Completion Date : | August 17, 2021 |
Actual Study Completion Date : | August 17, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: active treatment arm
Treatment with Canakinumab i.v. administered over 2 hours
|
Drug: Canakinumab
Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours
Other Name: Ilaris® |
Placebo Comparator: placebo treatment arm
placebo treatment
|
Drug: Placebo
Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours
Other Name: Aqua ad injectabilia in 250 ml 5% dextrose solution |
- 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.
- 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"
- Death rate [ Time Frame: 4 weeks ]Death rate during the 4-week period after study treatment
- 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
- 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)
- Prolonged hospital stay [ Time Frame: >3 weeks ]Prolonged hospital stay > 3 weeks
- Change in ratio to baseline in the glycated hemoglobin [ Time Frame: Baseline, Day 29 and Day 90 ]Ratio to baseline in the glycated hemoglobin
- Change in ratio to baseline in the fasting glucose [ Time Frame: Baseline, Day 29 ]Ratio to baseline in the fasting glucose
- Change in ratio to baseline in the fasting insulin [ Time Frame: Baseline, Day 29 ]Ratio to baseline in the fasting insulin
- Change in ratio to baseline in the fasting c-peptide [ Time Frame: Baseline, Day 29 ]Ratio to baseline in the fasting c-peptide
- 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)
- Change in ratio to baseline in the D-dimer [ Time Frame: Baseline, Day 29 ]Ratio to baseline in the D-dimer
- 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)
- 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)
- Type of antidiabetic treatment at Day 29 [ Time Frame: Day 29 ]Type of antidiabetic treatment at Day 29
- Number of antidiabetic treatment at Day 29 [ Time Frame: Day 29 ]Number of antidiabetic treatment at Day 29
- Type of antidiabetic treatment at three months [ Time Frame: Month 3 ]Type of antidiabetic treatment at three months
- Number of antidiabetic treatment at three months [ Time Frame: Month 3 ]Number of antidiabetic treatment at three months

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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-

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510493
Switzerland | |
University Medical Clinic Aarau | |
Aarau, Switzerland, 5001 | |
University Hospital Basel | |
Basel, Switzerland, 4031 | |
University Hospital Bern | |
Bern, Switzerland, 3010 | |
Hopital du Jura | |
Delémont, Switzerland, 2800 | |
University Hospital Geneva | |
Geneva, Switzerland, 1205 | |
University Hospital Lausanne | |
Lausanne, Switzerland, 1011 | |
Cantonal Hospital Lucerne | |
Luzern, Switzerland, 6004 | |
Cantonal Hospital St Gallen | |
St. Gallen, Switzerland, 9001 | |
University Hospital Zürich | |
Zürich, Switzerland, 8091 |
Principal Investigator: | Marc Donath, MD, Prof. | University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism |
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT04510493 |
Other Study ID Numbers: |
2020-02008; me20Donath2 |
First Posted: | August 12, 2020 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
NLRP3 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Disease 19 (COVID-19) |
IL-1beta hyperinflammatory syndrome obesity |
COVID-19 Coronavirus Infections Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Respiratory Tract Infections Infections |
Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |