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| Column | Value |
|---|---|
| Trial registration number | NCT04324073 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-03-27 |
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Recruitment status
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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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 belonging to one of the 2 following groups: group 1: patients not requiring icu at admission with moderate and severe pneumopathy according to the oms criteria of severity of covid pneumopathy. moderate cases : cases meeting all of the following criteria: showing fever and respiratory symptoms with radiological findings of pneumonia. requiring between 3l/min and 5l/min of oxygen to maintain spo2 >97% severe cases cases meeting any of the following criteria: respiratory distress (≧30 breaths/ min); oxygen saturation≤93% at rest in ambient air; or oxygen saturation ≤97 % with o2 > 5l/min. pao2/fio2≦300mmhg group 2: patients requiring icu based on criteria of severity of covid pneumopathy. respiratory failure and requiring mechanical ventilation no do-not-resuscitate order (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 sarilumab 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 should be discussed depending of the medication: - absolute neutrophil count (anc) ≤ 1.0 x 109/l - haemoglobin level: no limitation - platelets (plt) < 50 g /l - sgot or sgpt > 5n |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Assistance Publique - Hôpitaux de Paris |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe/critical disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
5: Moderate/severe/critical disease at enrollment |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
239 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Survival without needs of ventilator utilization at day 14.;WHO progression scale <=5 at day 4;Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14;WHO progression scale at day 4 |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1148, "treatment_name": "Sarilumab", "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"}] |