Best Supportive Care With or Without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19 (RESCUE1-19)

This is an interventional treatment trial for Pneumonia focused on measuring Radiotherapy, COVID-19, low dose radiotherapy, anti-inflammatory, cytokine storm Read More

Inclusion Criteria:

• Be age 50 or over; Not pregnant (will undergo pregnancy testing if below age 55);
• Have had a positive PCR-based test confirming the diagnosis of COVID-19 within 5 days (+/-2 day)of study enrollment*
• Have had clinical signs of severe acute respiratory syndrome or pneumonia (ie. dyspnea, cough,fever) that primary team feels like patient needs rescuing with LD-RT.**
• Have visible bilateral consolidations/ground glass opacities on chest imaging
• Require supplemental oxygen at the time of enrollment, defined by inability to wean from supplemental oxygen within 24 hours prior to enrollment.
• Not require intubation within 12 hours of randomization (ie, 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 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
• 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 therapeutric trial (subsequent co-enrollment is permitted for patinets 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, remdesevir, convalescent plasma, or any other COVIDdirected drug therapy.