Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT04510493
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2020-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Canakinumab in Patients With COVID-19 and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541220', 'term': 'canakinumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint)', 'timeFrame': 'within 4 weeks after treatment with canakinumab or placebo', 'description': '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):\n\n1. longer survival time\n2. longer ventilation-free time\n3. longer ICU-free time\n4. shorter hospitalization time\n\nIf 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.'}], 'secondaryOutcomes': [{'measure': 'Time to clinical improvement', 'timeFrame': 'From randomization up to 4 weeks', 'description': '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:\n\n1. not hospitalized with resumption of normal activities;\n2. not hospitalized, but unable to resume normal activities;\n3. hospitalized, not requiring supplemental oxygen;\n4. hospitalized, requiring supplemental oxygen;\n5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both;\n6. hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and\n7. death"'}, {'measure': 'Death rate', 'timeFrame': '4 weeks', 'description': 'Death rate during the 4-week period after study treatment'}, {'measure': 'Admission to intensive care unit (ICU)', 'timeFrame': '4 weeks', 'description': 'Admission to the intensive care unit from the medical ward during the 4-week period after study treatment'}, {'measure': 'Secondary worsening of disease', 'timeFrame': '4 weeks', 'description': 'Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment)'}, {'measure': 'Prolonged hospital stay', 'timeFrame': '>3 weeks', 'description': 'Prolonged hospital stay \\> 3 weeks'}, {'measure': 'Change in ratio to baseline in the glycated hemoglobin', 'timeFrame': 'Baseline, Day 29 and Day 90', 'description': 'Ratio to baseline in the glycated hemoglobin'}, {'measure': 'Change in ratio to baseline in the fasting glucose', 'timeFrame': 'Baseline, Day 29', 'description': 'Ratio to baseline in the fasting glucose'}, {'measure': 'Change in ratio to baseline in the fasting insulin', 'timeFrame': 'Baseline, Day 29', 'description': 'Ratio to baseline in the fasting insulin'}, {'measure': 'Change in ratio to baseline in the fasting c-peptide', 'timeFrame': 'Baseline, Day 29', 'description': 'Ratio to baseline in the fasting c-peptide'}, {'measure': 'Ratio to baseline in the C-reactive protein (CRP)', 'timeFrame': 'Baseline, Day 29 and Day 90', 'description': 'Ratio to baseline in the C-reactive protein (CRP)'}, {'measure': 'Change in ratio to baseline in the D-dimer', 'timeFrame': 'Baseline, Day 29', 'description': 'Ratio to baseline in the D-dimer'}, {'measure': 'Change in ratio to baseline in the Natriuretic peptide (NTproBNP)', 'timeFrame': 'Baseline, Day 29 and Day 90', 'description': 'Ratio to baseline in the Natriuretic peptide (NTproBNP)'}, {'measure': 'Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)', 'timeFrame': 'Baseline, Day 29 and Day 90', 'description': 'Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)'}, {'measure': 'Type of antidiabetic treatment at Day 29', 'timeFrame': 'Day 29', 'description': 'Type of antidiabetic treatment at Day 29'}, {'measure': 'Number of antidiabetic treatment at Day 29', 'timeFrame': 'Day 29', 'description': 'Number of antidiabetic treatment at Day 29'}, {'measure': 'Type of antidiabetic treatment at three months', 'timeFrame': 'Month 3', 'description': 'Type of antidiabetic treatment at three months'}, {'measure': 'Number of antidiabetic treatment at three months', 'timeFrame': 'Month 3', 'description': 'Number of antidiabetic treatment at three months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NLRP3', 'Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)', 'Coronavirus Disease 19 (COVID-19)', 'IL-1beta', 'hyperinflammatory syndrome', 'obesity'], 'conditions': ['Coronavirus Infection', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '36128334', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Body mass index \\> 25 kg/m² (overweight)\n* Hospitalized with COVID-19\n\nExclusion Criteria:\n\n* Suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of COVID-19\n* 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.\n* History of hypersensitivity to canakinumab or to biologic drugs\n* Neutrophil count \\<1000/mm3\n* Pregnant or nursing (lactating) women\n* Participation in another study with investigational drug within the 30 days preceding and during the present study-'}, 'identificationModule': {'nctId': 'NCT04510493', 'acronym': 'CanCovDia', 'briefTitle': 'Canakinumab in Patients With COVID-19 and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Canakinumab in Patients With COVID-19 and Type 2 Diabetes - CanCovDia Trial', 'orgStudyIdInfo': {'id': '2020-02008; me20Donath2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active treatment arm', 'description': 'Treatment with Canakinumab i.v. administered over 2 hours', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo treatment arm', 'description': 'placebo treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Canakinumab', 'type': 'DRUG', 'otherNames': ['Ilaris®'], 'description': 'Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours', 'armGroupLabels': ['active treatment arm']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Aqua ad injectabilia in 250 ml 5% dextrose solution'], 'description': 'Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours', 'armGroupLabels': ['placebo treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'University Medical Clinic Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '2800', 'city': 'Delémont', 'country': 'Switzerland', 'facility': 'Hopital du Jura', 'geoPoint': {'lat': 47.36493, 'lon': 7.34453}}, {'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University Hospital Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'University Hospital Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '6004', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Lucerne', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '9001', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Cantonal Hospital St Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Marc Donath, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Swiss National Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}