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

Phase 2TerminatedNCT04366791

Emory University47 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Low Dose Radiation TherapyRADIATION

Undergo low-dose radiation therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Emory University Hospital Midtown/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hosptial

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Rate of extubation (for intubated patients)

The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level.