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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04393051
Eligibility Criteria:
Inclusion Criteria:
* Any gender
* Age \> 18 years on day of signing informed consent
* Informed written consent for participation in the study
* Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
* Hospitalized due to clinical instrumental diagnosis of pneumonia.
* Oxygen saturation at rest in ambient air ≤93% or P/F ratio \<250
* Able to be administered by oral route drugs
* Patients who receive O2 therapy or who need non-invasive mechanical ventilation
* In case of female patients at childbearing potential, they should agree to use highly effective methods of birth control at least till 7 days after the termination of the treatments
Exclusion Criteria:
* Known hypersensitivity to Baricitinib or its excipients
* Patients with Creatinine Clearance \< 30 ml/min
* Patients with active Tuberculosis (TBC)
* Patients with known HBV or HCV infection
* Patients with deep vein thrombosis (DVP) or Pulmonary Embolism (PE)
* Patients with ALT or AST\> 5 times the upper limit of the normality
* Neutrophils \<1000/mmc
* Platelets \<50.000/mmc
* Hb\< 8g/dl
* Bowel diverticulitis or perforation
* Patients who receive invasive mechanical ventilation
* Documented bacterial infection at time of randomization
* Patients with "do not resuscitate order"
* Patients receiving immunosuppressants or anti-rejection drugs
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04393051
Study Brief:
Protocol Section:
NCT04393051