Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT04331808
Eligibility Criteria:
Inclusion Criteria:
1. Patients included in the CORIMUNO-19 cohort
2. Patients belonging to one of the 2 following groups:
* Group 1: Cases meeting all of the following criteria
* Requiring more than 3L/min of oxygen
* OMS/WHO progression scale = 5
* No Non Invasive Ventilation or High flow
* Group 2: Cases meeting all of the following criteria
* Respiratory failure AND (requiring mechanical ventilation OR Non Invasive Ventilation OR High flow)
* WHO progression scale \>=6
* No do-not-resuscitate order (DNR order)
Exclusion Criteria:
* Patients with exclusion criteria to the CORIMUNO-19 cohort.
* Known hypersensitivity to Tocilizumab 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04331808
Study Brief:
Protocol Section:
NCT04331808