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.
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:
Patients undergo 1 fraction of low-dose radiation therapy.
After completion of study treatment, patients are followed up at days 1-7, and 14 after last
dose of intervention.
Radiation: Low Dose Radiation Therapy
Undergo low-dose radiation therapy
Other Name: Low Dose Radiation
Inclusion Criteria:
- 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 Criteria:
- 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
Emory University Hospital Midtown/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hosptial
Atlanta, Georgia, United States
Mohammad Khan, MD, PhD, Principal Investigator
Emory University Hospital/Winship Cancer Institute