Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19)

Emory University

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Coronavirus Infection in 2019 (COVID-19)

Severe Acute Respiratory Syndrome (SARS) Pneumonia

Pneumonia

Treatments

Radiation: Low Dose Radiation Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04366791

P30CA138292 (U.S. NIH Grant/Contract)

STUDY00000476

NCI-2020-02676 (Registry Identifier)

RAD5002-20 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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