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Coronavirus InfectionPhase 3CanCovDiaNCT04510493

Canakinumab in Patients With COVID-19 and Type 2 Diabetes

A Phase 3 study testing Canakinumab in people with Coronavirus Infection and Diabetes Mellitus, Type 2, run by University Hospital, Basel, Switzerland at 9 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Canakinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
9 sitesSwitzerland
Study dates
23 Oct 2020to 17 Aug 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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-

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Switzerland9 sites

  • University Medical Clinic Aarau

    Aarau, 5001

  • University Hospital Basel

    Basel, 4031

  • University Hospital Bern

    Bern, 3010

  • Hopital du Jura

    Delémont, 2800

  • University Hospital Geneva

    Geneva, 1205

  • University Hospital Lausanne

    Lausanne, 1011

  • Cantonal Hospital Lucerne

    Lucerne, 6004

  • Cantonal Hospital St Gallen

    Sankt Gallen, 9001

  • University Hospital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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).

Read the detailed description

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.

Being tested
Canakinumab, Placebo
Keywords
NLRP3, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 19 (COVID-19), IL-1beta, hyperinflammatory syndrome, obesity
Medical subject headings
Coronavirus Infections, Diabetes Mellitus, Type 2, COVID-19, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CanakinumabDrug

    Also called Ilaris®

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

  • PlaceboDrug

    Also called Aqua ad injectabilia in 250 ml 5% dextrose solution

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

Study groups in NCT04510493
Study groupRoleWhat they receive
active treatment armActive comparatorTreatment with Canakinumab i.v. administered over 2 hours
Receives: Drug: Canakinumab
placebo treatment armPlacebo comparatorplacebo treatment
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: within 4 weeks after treatment with canakinumab or placebo

Secondary outcomes (17)

  1. 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"

    Measured: From randomization up to 4 weeks

  2. Death rate

    Death rate during the 4-week period after study treatment

    Measured: 4 weeks

  3. Admission to intensive care unit (ICU)

    Admission to the intensive care unit from the medical ward during the 4-week period after study treatment

    Measured: 4 weeks

  4. 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)

    Measured: 4 weeks

  5. Prolonged hospital stay

    Prolonged hospital stay > 3 weeks

    Measured: >3 weeks

  6. Change in ratio to baseline in the glycated hemoglobin

    Ratio to baseline in the glycated hemoglobin

    Measured: Baseline, Day 29 and Day 90

  7. Change in ratio to baseline in the fasting glucose

    Ratio to baseline in the fasting glucose

    Measured: Baseline, Day 29

  8. Change in ratio to baseline in the fasting insulin

    Ratio to baseline in the fasting insulin

    Measured: Baseline, Day 29

  9. Change in ratio to baseline in the fasting c-peptide

    Ratio to baseline in the fasting c-peptide

    Measured: Baseline, Day 29

  10. Ratio to baseline in the C-reactive protein (CRP)

    Ratio to baseline in the C-reactive protein (CRP)

    Measured: Baseline, Day 29 and Day 90

  11. Change in ratio to baseline in the D-dimer

    Ratio to baseline in the D-dimer

    Measured: Baseline, Day 29

  12. Change in ratio to baseline in the Natriuretic peptide (NTproBNP)

    Ratio to baseline in the Natriuretic peptide (NTproBNP)

    Measured: Baseline, Day 29 and Day 90

  13. Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

    Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

    Measured: Baseline, Day 29 and Day 90

  14. Type of antidiabetic treatment at Day 29

    Type of antidiabetic treatment at Day 29

    Measured: Day 29

  15. Number of antidiabetic treatment at Day 29

    Number of antidiabetic treatment at Day 29

    Measured: Day 29

  16. Type of antidiabetic treatment at three months

    Type of antidiabetic treatment at three months

    Measured: Month 3

  17. Number of antidiabetic treatment at three months

    Number of antidiabetic treatment at three months

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start23 Oct 2020
  3. Primary completion17 Aug 2021
  4. Study completion17 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510493
Sponsor's protocol ID
2020-02008; me20Donath2
Acronym
CanCovDia
Status last verified
Sep 2021
First submitted
11 Aug 2020
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36128334

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canakinumab in people with Coronavirus Infection and Diabetes Mellitus, Type 2, run by University Hospital, Basel, Switzerland at 9 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint) (time frame: within 4 weeks after treatment with canakinumab or placebo). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510493, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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