Georgia's Online Cancer Information Center

Find A Clinical Trial

Low-Dose Radiation Therapy for the Treatment of Storming Cytokines and Unchecked Edema in Patients with COVID-19 Infection, RESCUE 1-19 Study

Status
Temporarily Closed
Cancer Type
COVID-19
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04366791
Protocol IDs
RAD5002-20 (primary)
NCI-2020-02676
Study Sponsor
Emory University Hospital/Winship Cancer Institute

Summary

This phase I/II trial studies how well low-dose radiation therapy works in treating patients with SARS or pneumonia associated with COVID-19 infection. The purpose of this study is to investigate the use of selectively localized low-dose radiation therapy in reducing pulmonary immuno-toxicity (lung damage) within viral pneumonia infiltrates in critically-ill patients with SARS-COVID-19.

Objectives

PRIMARY OBJECTIVE:
I. To investigate clinical, radiographic, and immune outcomes in critically-ill patients with severe acute respiratory syndrome coronavirus disease 2019 (SARS-COVID-19) following whole-lung low-dose radiation therapy (LDRT).

OUTLINE:
Patients undergo 1 fraction of low-dose radiation therapy.

After completion of study treatment, patients are followed up at days 3, 7, 14, 21, and 28 after last dose of intervention.

Eligibility

  1. Have had a positive test confirming the diagnosis of COVID-19
  2. Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment)
  3. Have visible consolidations/ground glass opacities on chest x-ray or computed tomography
  4. 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 (Cohorts 1 and 2 only)
  5. Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
  6. 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

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**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.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.