Overview
This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.
Description
PRIMARY OBJECTIVE:
I. Time to clinical recovery based on reducing the need of supplementary oxygenation in COVID 19 patients.
SECONDARY OBJECTIVES:
I. To investigate (1) clinical, (2) radiographic, and (3) immune marker response to whole-lung LDRT compared to best standard of care.
II. Secondary clinical improvements will look at time to hospital discharge, prevention of ICU admissions, and overall survival.
OUTLINE: Patients are blindly randomized to 1 of 2 arms.
ARM I: Patients receive best supportive care plus physician choice of treatment
ARM II: Patients receive best supportive care plus LDRT (experimental arm).
After completion of study, patients are followed up for 14 days.
Eligibility
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, fever) that primary team feels like needs rescuing with treatments
- Have visible consolidations/ground glass opacities on chest imaging
- Requiring supplemental oxygen
- 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 prior to randomization: Remdesivir or whatever drug may have been approved as standard of care to treat COVID patients. After consenting and randomization, patient could get remdesivir and/or other approved standard of care treatments on the standard of care arm as physician's choice. However, they would not be allowed to receive this on the radiotherapy arm until interim analysis is completed (i.e., after the first 8 patients enrolled on both arms with at least 14 day follow-up. This would especially be the case, if we see a vast superiority of one arm over another for the primary endpoints, that puts patients at risks from obtaining the standard of care treatments) However, patient could recieve such therapy if they are mechanically ventilated.
- Pregnant and/or planned to be pregnant within in next 6 months