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SNCTP000004039 | NCT04510493 | BASEC2020-02008

Canakinumab in Patienten mit COVID-19 und Typ 2 Diabetes

Data source: BASEC (Imported from 29.03.2024), WHO (Imported from 29.03.2024)
Changed: Dec 23, 2023, 4:54 PM
Disease category: Nutritional and Metabolic diseases, Endocrinological diseases (non cancer), Infections and Infestations

Brief description of trial (Data source: BASEC)

Adipöse und Typ 2 Diabetiker zählen zu den besonders gefährdeten Patienten für schwere Verläufe von Sars-CoV2-infizierten Patienten. Eine Überaktivierung des Immunsystems mit Erhöhung von IL-1beta spielt eine besondere Rolle bei Adipösen und Typ 2 Diabetikern. Eine Hemmung des IL-1ß durch verschiedene Wirkstoffe hat in mehreren Studien den Diabetes verbessert und in einer grossen Studie (CANTOS-Studie) mit dem Medikament Canakinumab bei Patienten, die bereits einen Herzinfarkt oder einen Schlaganfall hatten, zu einem geringeren Auftreten von neuen Herz-Kreislauf-Ereignissen geführt. Entsprechend wird in dieser Studie untersucht, ob die Behandlung mit dem Entzündungshemmer (Canakinumab) den Verlauf von COVID-19 bei Typ 2 Diabetikern günstig beeinflusst.

Health conditions investigated(Data source: BASEC)

COVID-19 , Diabetes Typ 2

Health conditions (Data source: WHO)

Coronavirus Infection;Diabetes Mellitus, Type 2

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Canakinumab (Ilaris®, Novartis)

Interventions (Data source: WHO)

Drug: Canakinumab;Drug: Placebo

Criteria for participation in trial (Data source: BASEC)

- Schriftliche Einverständniserklärung
- Alter ≥ 18 Jahre
- Diagnose von Typ-2-Diabetes mellitus
- Body Mass Index> 25 kg / m² (Übergewicht)
- Mit COVID-19 ins Krankenhaus eingeliefert

Exclusion criteria (Data source: BASEC)

- Verdacht auf oder bekannte unbehandelte Infektion mit aktiven Bakterien, Pilz, Viren oder Parasiten mit Ausnahme von COVID-19
- Behandlung mit Immunmodulatoren oder Immunsuppressiven
Arzneimittel, einschließlich, aber nicht beschränkt auf Tocilizumab, TNF-Inhibitoren und Anti-IL-17-Wirkstoff innerhalb von 5 Halbwertszeiten oder 30 Tagen (je nachdem was länger ist) vor der Randomisierung mit Ausnahme von Anakinra (dies nur innerhalb von 5 Halbwertszeiten)
- Überempfindlichkeit gegen Canakinumab oder biologische Arzneimittel
- Neutrophilenzahl <1000 / mm3
- Schwange oder stillende Frauen

Inclusion/Exclusion Criteria (Data source: WHO)


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-

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04510493

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04510493
Further information on trial

Date trial registered

Aug 11, 2020

Incorporation of the first participant

Oct 23, 2020

Recruitment status

Recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

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

Secundary end point (Data source: WHO)

Number of antidiabetic treatment at three months;Type of antidiabetic treatment at three months;Number of antidiabetic treatment at Day 29;Type of antidiabetic treatment at Day 29;Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR);Change in ratio to baseline in the Natriuretic peptide (NTproBNP);Change in ratio to baseline in the D-dimer;Ratio to baseline in the C-reactive protein (CRP);Change in ratio to baseline in the fasting c-peptide;Change in ratio to baseline in the fasting insulin;Change in ratio to baseline in the fasting glucose;Change in ratio to baseline in the glycated hemoglobin;Prolonged hospital stay;Secondary worsening of disease;Admission to intensive care unit (ICU);Death rate;Time to clinical improvement

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Basel, Geneva, Lausanne, Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. Marc Y. Donath
+41 61 265 25 25
marc.donath@usb.ch

Contact for general information (Data source: WHO)

Marc Donath, MD, Prof.
University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
+41 61 265 5078.
marc.donath@usb.ch

Contact for scientific information (Data source: WHO)

Marc Donath, MD, Prof.
University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
+41 61 265 5078.
marc.donath@usb.ch

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

11.09.2020

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2020-02008

Secondary ID (Data source: WHO)

me20Donath2
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