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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT04427566
Eligibility Criteria:
Inclusion Criteria:
* Laboratory Diagnosis of COVID-19 based within 14 days of enrollment.
* CT or radiographic findings typical of COVID-19 pneumonia within 5 days of enrollment
* Receiving ICU-based mechanical ventilation
* Life expectancy ≥ 24 hours, as judged by investigator
* Hypoxemia defined as a Pa/FIO2 ratio \< 300 or SpO2/FiO2 \< 315
* Signed informed consent by patient or his or her legal/authorized representative
Exclusion Criteria:
* Moribund with survival expected \< 24 hours, as judged by investigator and treating team
* Expected survival \< 30 days, as judged by investigator and treating team, due to chronic illness present prior to COVID infection
* Patient or legal representative not committed to full disease specific therapy, i.e. comfort care (DNRCCA is allowed)
* Treatment with immune suppressing medications in the last 30 days (steroids for acute respiratory distress syndrome or septic shock allowed)
* Presumed COVID-associated illness greater than 14-days
* Inpatient admission greater than 14-days
* Patient deemed unsafe for travel for radiation therapy
* Chronic hypoxemia requiring supplemental oxygen at baseline
* Documented active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
* History of prior radiation therapy resulting in ≥grade 2 radiation pneumonitis within 365 days of enrollment
* Active or history of prior radiation to the thorax completed within 180 days of enrollment (skin or surface only skin treatments are acceptable)
* Known active uncontrolled bacterial or fungal infections of the lung.
* Active cytotoxic chemotherapy
* Females who are pregnant or have a positive pregnancy test
* Breast feeding
* Note: concurrent administration of convalescent immune plasma therapy either on clinical trial or as a standard therapy not an exclusion criterion, but will be noted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04427566
Study Brief:
Protocol Section:
NCT04427566