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Clinical Trial Details

Trial ID: L6712
Source ID: NCT04510493
Associated Drug: Canakinumab
Title: Canakinumab in Patients With COVID-19 and Type 2 Diabetes
Acronym: CanCovDia
Status: COMPLETED
Study Results: NO
Results:
Conditions: Coronavirus Infection|Diabetes Mellitus, Type 2
Interventions: DRUG: Canakinumab|DRUG: Placebo
Outcome Measures: Primary: 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): 1. longer survival time 2. longer ventilation-free time 3. longer ICU-free time 4. 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., within 4 weeks after treatment with canakinumab or placebo | Secondary: 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: 1. not hospitalized with resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalized, not requiring supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7. death", 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
Sponsor/Collaborators: Sponsor: University Hospital, Basel, Switzerland | Collaborators: Novartis|Swiss National Science Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 116
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-10-23
Completion Date: 2021-08-17
Results First Posted:
Last Update Posted: 2021-09-08
Locations: University Medical Clinic Aarau, Aarau, 5001, Switzerland|University Hospital Basel, 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, Luzern, 6004, Switzerland|Cantonal Hospital St Gallen, St. Gallen, 9001, Switzerland|University Hospital Zürich, Zürich, 8091, Switzerland
URL: https://clinicaltrials.gov/show/NCT04510493