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

Active:	No
Cancer Type:	COVID-19	NCT ID:	NCT04433949
Trial Phases:	Phase III	Protocol IDs:	RAD5049-20 (primary) NCI-2020-04061 STUDY00000781
Eligibility:	50 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04433949

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.

**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.