Canakinumab in Patients With COVID-19 and Type 2 Diabetes

NCT04510493 | Completed Phase 3

• 1 other identifier: 2020-02008; me20Donath2
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 9

Brief Summary

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).

Conditions

Coronavirus Infection; Diabetes Mellitus, Type 2

Keywords

NLRP3; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Coronavirus Disease 19 (COVID-19); IL-1beta; hyperinflammatory syndrome; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Time to clinical improvement

  From randomization up to 4 weeks

• Death rate

  4 weeks

• Admission to intensive care unit (ICU)

  4 weeks

• Secondary worsening of disease

  4 weeks

• Prolonged hospital stay

  >3 weeks

Study Arms (2)

active treatment arm

ACTIVE COMPARATOR

Treatment with Canakinumab i.v. administered over 2 hours

Drug: Canakinumab

placebo treatment arm

PLACEBO COMPARATOR

placebo treatment

Drug: Placebo

Interventions

Canakinumab DRUG

Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours

Also known as: Ilaris®

active treatment arm

Placebo DRUG

Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours

Also known as: Aqua ad injectabilia in 250 ml 5% dextrose solution

placebo treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus
• Body mass index \> 25 kg/m² (overweight)
• Hospitalized with COVID-19

You may not qualify if:

• 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-

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Novartis: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (9)

University Medical Clinic Aarau

Aarau, 5001, Switzerland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Hopital du Jura

Delémont, 2800, Switzerland

Location

University Hospital Geneva

Geneva, 1205, Switzerland

Location

University Hospital Lausanne

Lausanne, 1011, Switzerland

Location

Cantonal Hospital Lucerne

Lucerne, 6004, Switzerland

Location

Cantonal Hospital St Gallen

Sankt Gallen, 9001, Switzerland

Location

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36128334 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Diabetes Mellitus, Type 2; COVID-19; Obesity

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Donath, MD, Prof.

  University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 12, 2020
• Study Start: October 23, 2020
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

CH (9)