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

This phase III trial compares best supportive care combined with low dose whole lung radiation therapy vs. best supportive care alone in treating patients with COVID-19 infection. Low-dose radiation therapy is a type of radiation treatment in which the total dose of radiation is less than that given in standard radiation therapy. The radiation dose used in this study is unlikely to cause short term side effects other than fatigue and temporary low blood cell count. The addition of low dose whole lung radiation therapy to best supportive care may improve patients' clinical status, the radiographic appearance of lungs and / or the laboratory blood tests.

Inclusion Criteria

• Not pregnant (will undergo pregnancy testing if below age 50)
• Have had a positive test confirming the diagnosis of COVID-19 * 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 treatments * Patients be enrolled and randomized within their first week (7 days) of hospital admission +/- 2 days
• Have visible consolidations/ground glass opacities on chest imaging * Patients have bilateral infiltrates or peripheral ground glass opacities
• Requiring supplemental oxygen * Patients undergo attempted weaning of supplemental oxygen prior to enrollment and demonstrate inability to tolerate room air for a 12-hour period wherein they consistently maintaining saturations > 90%
• 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

• Use of disallowed medications prior to randomization, including remdesivir, hydroxychloroquine, glucocorticoid steroids or other COVID-directed therapies. This does not apply to azithromycin given its lack of published efficacy. Azithromycin must be discontinued at the time of enrollment but does not exclude a patient from study participation. After enrollment, patients randomized to receive best supportive care plus provider’s choice of therapy may receive any COVID-directed therapy at provider discretion. However, administration of COVID-directed therapies is prohibited for patients randomized to the interventional arm of best supportive care plus radiation, with one exception. If a patient who has received radiation therapy experiences clinical decline after radiation delivery and requires intubation or mechanical ventilation, he or she may thereafter receive any COVID-directed therapy at providers’ discretion
• Pregnant and/or planned to be pregnant within in next 6 months (will undergo pregnancy testing)

PRIMARY OBJECTIVE:

I. Time to clinical recovery based on reducing the need of supplementary oxygenation in coronavirus disease 2019 (COVID 19) patients.

SECONDARY OBJECTIVES:

I. To investigate (1) clinical, (2) radiographic, and (3) immune marker response to best supportive care plus whole-lung low dose whole-lung radiation therapy (LD-RT) compared to best supportive care plus provider’s treatment choice.

II. Monitor improvement in chest xrays, changes in Glasgow coma scale, time to hospital discharge, overall survival, freedom from intubation, freedom from intensive care unit (ICU) admission, and changes in biomarkers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo bilateral LDRT over 30 minutes and receive best supportive care.

ARM II: Patients only receive best supportive care.

After completion of study, patients are followed up for 14 days.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
Mohammad Khurram Khan

• Primary ID RAD5049-20
• Secondary IDs NCI-2020-04061, STUDY00000781
• Clinicaltrials.gov ID NCT04433949