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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04361903
Eligibility Criteria:
Inclusion Criteria:
* positive analysis for RT PCR (Shanghai BioTec or Sansure Biotech) for SARS-CoV-2 in a respiratory tract sample;
* Imaging (CT / ECO / RX) positive for pneumonia;
* Oxygen saturation (SaO2) of 93% or less in the environment;
* Partial oxygen pressure ratio (PaO2) on inspired oxygen fraction (FiO2) (PaO2 / FiO2) lower than 250 mg / Hg, but not lower than 100 mg / Hg;
* Rapid clinical evolution with worsening of respiratory parameters in the last 12 hours.
* Release of informed consent.
Exclusion Criteria:
* Pregnancy and breastfeeding;
* Patients already in assisted breathing with tracheal cannula;
* Patients with active and uncompensated serious pathologies previously to the COVID 19 infection;
* Known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the SPC;
* Patients with renal insufficiency;
* Patients with positive quantiferon;
* Patients with documented uncontrolled bacterial sepsis (excluding procalcitonin increase in the presence of negative blood cultures);
* Patients with neutropenia equal to or less than 1000 PMN / mmc;
* Patients with thrombocytopenia equal to or less than 100000 / mmc.
* HCV and / or HBV positive patients, HIV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04361903
Study Brief:
Protocol Section:
NCT04361903