Status:
TERMINATED
Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pneumonia
Coronavirus Infection in 2019 (COVID-19)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.
Detailed Description
PRIMARY OBJECTIVE: I. To compare treatment of COVID-19 between best supportive care plus provider's treatment choice versus best supportive care plus low-dose, whole-lung radiation therapy OUTLINE: ...
Eligibility Criteria
Inclusion
- Have had a positive test confirming the diagnosis of COVID-19
- Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment)
- Have visible consolidations/ground glass opacities on chest x-ray or computed tomography
- Have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy.
- Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
- Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
Exclusion
- No use of disallowed medications 1 day prior to delivery of LDRT: Azithromycin, chloroquine, hydrochloroquine, COVID-targeted antiviral medications
- Pregnant and/or planned to be pregnant within in next 6 months
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04366791
Start Date
April 24 2020
End Date
March 11 2022
Last Update
March 29 2022
Active Locations (2)
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1
Emory University Hospital Midtown/Winship Cancer Institute
Atlanta, Georgia, United States, 30308
2
Emory Saint Joseph's Hosptial
Atlanta, Georgia, United States, 30342