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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT04337359
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
Written patient informed consent or assent must be obtained prior to start of treatment.
* Patients aged ≥ 6 years
* Patients clinically diagnosed with SARS-CoV-2 infection, either through positive serum antibodies (IgM or IgG); or by PCR; or by other approved diagnostic methodology. Patients with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and SARS-CoV-2 test pending) may be included.
* Adult and adolescent patients (≥12years), who meet one of the below criteria
* Respiratory frequency ≥ 30/min
* Oxygen saturation ≤ 93% on room air (FiO2=0.21)
* Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) \<300mmHg(1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).
AND
\-- Patients with lung imaging showing pulmonary infiltrates (chest X-ray or CT scan)
Pediatric patients (≥6-\<12 years) who meet one of the below criteria (where appropriate):
* Shortness of breath
* Oxygen saturation \<92% on room air (Fi)2=0.21)
* Labored breathing (e.g. wheezing, flaring of nostrils, three concave sign), cyanosis, intermittent apnea.
* Lethargy or convulsions
* Refusal to eat or difficulty with feeding; signs of dehydration
Exclusion Criteria:
* Patients eligible for this Treatment Plan must not meet any of the following criteria:
* History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib
* Presence of severely impaired renal function defined by serum creatinine \> 2 mg/dL (\>176.8 μmol/L), or have estimated creatinine clearance \< 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.
* Pregnant or nursing (lactating) women.
* Patients who are NOT able to understand and to comply with treatment instructions and requirements unless health care proxy is able to provide consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
90 Years
Study:
NCT04337359
Study Brief:
Protocol Section:
NCT04337359