Status:
RECRUITING
Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Low doses of radiation in the form of chest X-rays have been used to treat people with pneumonia. This treatment was found to be effective by reducing inflammation and with minimal side effects. Howev...
Detailed Description
The primary outcome is the mortality rate 30 days after the ICU-based mechanical ventilation initiation.Based on current data available, the mortality rate for ventilated patients is assumed to be 80%...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04427566
Start Date
July 23 2020
End Date
December 31 2021
Last Update
March 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210