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Trial - NCT04362813


Column Value
Trial registration number NCT04362813
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04362813

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Novartis Pharmaceuticals

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

novartis.email@novartis.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-27

Recruitment status
Last imported at : Feb. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Aug. 17, 2021, 6 p.m.
Source : ClinicalTrials.gov

key inclusion criteria: - adults ≥ 18 years old (for us only: patients ≥ 12 years old, although no children ever enrolled. this was an adult trial.) - body weight ≥40 kg - informed consent must be obtained prior to participation in this study. for us patients 12 - < 18 years old; parent/guardian consent must be obtained and assent if applicable. - clinically diagnosed with sars-cov-2 virus by pcr or by other approved diagnostic methodology - hospitalized with covid-19-induced pneumonia evidenced by chest x-ray or ct scan with pulmonary infiltrates - spo2 ≤ 93% on room air or arterial oxygen partial pressure (pao2)/ fraction of inspired oxygen (fio2) < 300mmhg - c-reactive protein ≥20 mg/l or ferritin level ≥600 µg/l key

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- history of hypersensitivity to canakinumab or to biologic drugs - intubated and on mechanical ventilation (invasive) at time of randomization - treatment with immunomodulators or immunosuppressant drugs, including but not limited to tocilizumab, 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) are permitted. - suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of covid-19

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Novartis Pharmaceuticals

Inclusion age min
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

France;Italy;Russia;Spain;United Kingdom;United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Aug. 17, 2021, 6 p.m.
Source : ClinicalTrials.gov

454

primary outcome
Last imported at : Aug. 17, 2021, 6 p.m.
Source : ClinicalTrials.gov

Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Results also available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001370-30/results", "treatment_id": 247, "treatment_name": "Canakinumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results also available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001370-30/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]