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

Status
Active
Cancer Type
COVID-19
Trial Phase
Phase III
Eligibility
50 Years and older, Male and Female
Study Type
Supportive care
NCT ID
NCT04433949
Protocol IDs
RAD5049-20 (primary)
NCI-2020-04061
STUDY00000781
Study Sponsor
Emory University Hospital/Winship Cancer Institute

Summary

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.

Objectives

PRIMARY OBJECTIVES:
I. Intubation free-survival based on weaning off supplementary oxygenation or hospital discharge in coronavirus disease 2019 (COVID 19) patients.
II. Time to clinical recovery (TTCR) based on weaning off supplementary oxygenation or hospital discharge in COVID 19 patients.

SECONDARY OBJECTIVE:
I. To investigate (1) other clinical, (2) radiographic, (3) serologic markers, and (4) immune marker response to best supportive care plus provider's choice of pharmaceutical treatment either with or without whole-lung low dose whole-lung radiation therapy (LD-RT).

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.

Eligibility

  1. Not pregnant (will undergo pregnancy testing if below age 55)
  2. 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
  3. 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
  4. Have visible bilateral consolidations/ground glass opacities on chest imaging * Patients have bilateral infiltrates or peripheral ground glass opacities on computed tomography (CT) chest
  5. 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%
  6. 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
  7. 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)
  8. Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
  9. 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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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