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Trial - NCT04341584


Column Value
Trial registration number NCT04341584
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04341584

First author
Last imported at : Feb. 2, 2021, 5:16 p.m.
Source : ClinicalTrials.gov

Xavier Mariette, MD, PhD

Contact
Last imported at : Feb. 2, 2021, 5:16 p.m.
Source : ClinicalTrials.gov

xavier.mariette@aphp.fr

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

2020-04-10

Recruitment status
Last imported at : Feb. 2, 2021, 5:16 p.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

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

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

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: patients included in the corimuno-19 cohort patients with c-reactive protein level (crp) > 25 mg / l the day or the day before the infusion) patients belonging to one of the 2 following groups: group 1: patients meeting all of the following criteria: 1) requiring more than 3l/min of oxygen; 2) who progression scale = 5; 3) no niv or high flow group 2: patients with respiratory failure and (requiring mechanical ventilation or niv or high flow), with a who progression scale ≥ 6, and no do-not-resuscitate (dnr) order

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

- patients with exclusion criteria to the corimuno-19 cohort. - known hypersensitivity to anakinra or to any of their excipients. - pregnancy - current documented bacterial infection. - patient with any of following laboratory results out of the ranges detailed below at screening: - absolute neutrophil count (anc) ≤ 1.0 x 109/l - haemoglobin level: no limitation - platelets (plt) < 50 g /l - sgot or sgpt > 5n - severe renal insufficiency with glomerular filtration rate < 30 ml / mn

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

Assistance Publique - Hôpitaux de Paris

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

18

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

None

Countries
Last imported at : Feb. 2, 2021, 5:16 p.m.
Source : ClinicalTrials.gov

France

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

Severe/critical disease at enrollment

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

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Feb. 2, 2021, 5:16 p.m.
Source : ClinicalTrials.gov

161

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

WHO progression scale ≤ 5;Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14;Decrease of at least one point in WHO progression scale score;Survival without needs of ventilator utilization at day 14

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 2

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

[{"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]