NCT04433949

Best Supportive Care With or Without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19

Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19): A Randomized Phase III Trial of Best Supportive Care Plus Provider's Choice of Pharmaceutical Treatment With or Without Whole Lung Low-Dose Radiation Therapy (LD-RT) in Hospitalized Patients With COVID-19

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.

Detailed description

PRIMARY OBJECTIVE: I. Intubation-free survival (IFS) and (2) time to clinical recovery (TTCR) based on weaning off supplementary oxygenation or hospital discharge in COVID 19 patients. SECONDARY OBJECTIVES: 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 LD-RT II. Secondary clinical improvements will look at time to hospital discharge, prevention of ICU admissions, and overall survival. OUTLINE: Patients are blindly randomized to 1 of 2 arms. ARM I: Patients receive best supportive care plus physician choice of treatment ARM II: Patients receive best supportive care plus LDRT (experimental arm). After completion of study, patients are followed up for 14 days.

Conditions

• Pneumonia
• Severe Acute Respiratory Syndrome
• Symptomatic COVID-19 Infection Laboratory-Confirmed

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
RADIATION	Low Dose Radiation Therapy	Undergo LDRT

Timeline

• Start date: 2020-06-23
• Primary completion: 2022-10-19
• Completion: 2024-05-30
• First posted: 2020-06-16
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study