Best Supportive Care with or without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19 Infection

Inclusion Criteria

• Not pregnant (will undergo pregnancy testing if below age 55)
• Have had a positive polymerase chain reaction (PCR)-based test confirming the diagnosis of COVID-19 within 5 days (+/- 2 days) of study enrollment * Patients have tested COVID positive within 72 hours of enrollment
• Have had clinical signs of severe acute respiratory syndrome or pneumonia (i.e., dyspnea, cough, fever) that primary team feels like needs rescuing with LD-RT * Patients be enrolled and randomized within their first week (3 days) of hospital admission +/- 2 days
• Have visible bilateral consolidations/ground glass opacities on chest imaging * Patients have bilateral infiltrates or peripheral ground glass opacities on computed tomography (CT) chest
• Require supplemental oxygen at the time of enrollment, defined by inability to wean from supplemental oxygen within 24 hours prior to enrollment * Patients undergo attempted weaning of supplemental oxygen prior to enrollment and demonstrate inability to tolerate room air for a 24-hour period wherein they consistently maintaining saturations > 90%
• Not require intubation within 12 hours of randomization (i.e. not screen fail). Intubation after enrollment but within 12 hours of randomization will be defined as a screen failure for both the LD-RT and control cohorts
• Be enrolled within 5 days (+/-2) of first hospitalization for COVID-19. Prior hospitalization for COVID-19 will be an exclusion criteria (prior Emergency Department [ED] visits are permissible)
• 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

• Pregnant and/or planned to be pregnant within in next 6 months (will undergo pregnancy testing if age 55 or younger)
• Age 49 or younger at time of enrollment
• Prior inpatient hospitalization for COVID-19 (prior emergency department [ED] visits are not an exclusion criteria)
• Prior enrollment on a separate COVID-19 related therapeutic trial (subsequent co-enrollment is permitted for patients randomized to the control arm)
• Notably, concurrent use of COVID-directed therapies is no longer an exclusion criteria for this trial. This includes azithromycin, dexamethasone, remdesivir, convalescent plasma, or any other COVID-directed drug therapy