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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04476979 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-20 |
|
Recruitment status
Last imported at : June 9, 2022, 4 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 : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
inclusion criteria: patients included in the corimuno-19 cohort patients belonging to the following group: requiring ≥ 3l/min of oxygen who progression scale = 5 no niv or high flow |
|
Exclusion criteria
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
patients with exclusion criteria to the corimuno-19 cohort. known hypersensitivity to tocilizumab or dxm or to any of their excipients. pregnancy current documented bacterial infection not controlled by antibiotics. certain evolving viral diseases (especially active herpes, chickenpox, shingles), psychotic states still not controlled by treatment, live vaccines in the previous 4 weeks, active tuberculosis or disseminated strongyloidiasis 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 |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Assistance Publique - Hôpitaux de Paris |
|
Inclusion age min
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
French Guiana |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
|
Total sample size
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
453 |
|
primary outcome
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Survival without needs of invasive ventilation 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": 1719, "treatment_name": "Dexamethasone+tocilizumab", "treatment_type": "Corticosteroids+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}] |