Official Title
The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
Brief Summary

This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.

Detailed Description

PRIMARY OBJECTIVE:



I. To compare treatment of COVID-19 between best supportive care plus provider's treatment

choice versus best supportive care plus low-dose, whole-lung radiation therapy



OUTLINE:



Patients undergo 1 fraction of low-dose radiation therapy.



After completion of study treatment, patients are followed up at days 1-7, and 14 after last

dose of intervention.

Recruiting
Pneumonia
Coronavirus Infection in 2019 (COVID-19)
Severe Acute Respiratory Syndrome (SARS) Pneumonia

Radiation: Low Dose Radiation Therapy
Undergo low-dose radiation therapy
Supportive care (low-dose radiation therapy)
Other Name: Low Dose Radiation

Eligibility Criteria

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, with need for oxygen support at the time of enrollment) - Have visible consolidations/ground glass opacities on chest x-ray or computed tomography - Have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy. - 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 1 day prior to delivery of LDRT: Azithromycin, chloroquine, hydrochloroquine, COVID-targeted antiviral medications - Pregnant and/or planned to be pregnant within in next 6 months

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Emory University Hospital Midtown/Winship Cancer Institute
Atlanta, Georgia, 30308

Recruiting

Investigator: Clayton B. Hess
cbhess@emory.edu

Investigator: Clayton B. Hess, MD MPH

Investigator: Mohammad K. Khan, MD PhD

Contacts

Clayton Hess, MD, MPH
404-686-2391
cbhess@emory.edu

Autumn Lunceford
404-686-1638
patricia.autumn.lee.lunceford@emory.edu

Clayton B Hess, MD, MPH
Principal Investigator
Emory University Hospital/Winship Cancer Institute

~

Mohammad K Khan, MD, PhD
Principal Investigator
Emory University Hospital/Winship Cancer Institute

Emory University
NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia