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:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT04424056
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 year up to 75 year-old maximum
* Eligible for resuscitation care in UCI
* with proven infection with COVID-19, using at least one positive pharyngeal polymerase chain reaction (PCR) test
* COVID19 infection pneumonia at
* Stage 2b: Hypoxemic pneumonia (respiratory rate \>30/min, Sat O2\<90 mm Hg in ambient air) associated with a marked biological inflammatory syndrome (CRP\>150mg/l) - or Stage 3: ARDS defined by a mechanically ventilated patient with a PaO2/FiO2 ratio \< 300 for more than 24 hours.
* or Advanced Stage 3: moderate to severe ARDS (PaO2/FiO2 \< 200 to PEEP of at least 8 cmH2O) on invasive mechanical ventilation associated with another organ failure or syndrome among : 1) Shock with norepinephrine dosage \> 3 mg/hour, 2) Acute renal oligo-anuric failure or requiring extra-renal lavage, 3) Hepatocellular failure or coagulopathy with factor V \< 50%, 4) Myocarditis causing acute heart failure and/or shock. , 5) Hemophagocytic syndrome, 6) Hyperferritinemia \> 5000 ng/mL
Exclusion Criteria:
* Patients younger than 18 or older than 75 year-old,
* Pregnant or breastfeeding woman
* Patient for whom measures of therapeutic limitations have been issued (non-admission to intensive care unit)
* Patients treated with immunosuppressant/immunomodulators (Not only the concomitant administration of the following drugs prohibited in the protocol: other JAK inhibitors, corticosteroids, IL6 inhibitors).
* Patient already included in another interventional therapeutic trial
* Use of chronic oral corticosteroids \> 10 mg prednisone equivalent per day for non-COVID-19 related disease
* Uncontrolled autoimmune disease
* Patients with active, suspected or known active systemic bacterial, viral (excluding COVID-19) or fungal infections that are not controlled (not only HIV, HBV or HCV infection and untreated bacterial or mycotic infection)
* Patients with severe pre-existing uncontrolled organ dysfunction (heart, liver or kidney failure) not related to COVID-19
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04424056
Study Brief:
Protocol Section:
NCT04424056