Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04427566

Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise

Led by Ohio State University Comprehensive Cancer Center · Updated on 2021-03-15

24

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Low doses of radiation in the form of chest X-rays have been used to treat people with pneumonia. This treatment was found to be effective by reducing inflammation and with minimal side effects. However, it was an expensive treatment and was eventually replaced with less costly treatments such as antibiotics. Radiation has also been shown in some animal experiments to reduce some types of inflammation. Some patients diagnosed with COVID-19 pneumonia will experience worsening disease, which can become very serious, requiring the use of a ventilator. This is caused by inflammation in the lung from the virus and the immune system. For this study, the x-ray given is called radiation therapy. Radiation therapy uses high-energy X-ray beams from a large machine to target the lungs and reduce inflammation. Usually, it is given at much higher doses to treat cancers. The purpose of this study is to find out if adding a single treatment of low-dose x-rays to the lungs might reduce the amount of inflammation in the lungs from a COVID-19 infection, which could help a patient to breathe without use of a ventilator.

CONDITIONS

Official Title

Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Laboratory diagnosis of COVID-19 within 14 days of enrollment
  • CT or X-ray findings typical of COVID-19 pneumonia within 5 days of enrollment
  • Receiving mechanical ventilation in an intensive care unit (ICU)
  • Life expectancy of at least 24 hours as judged by the investigator
  • Hypoxemia with Pa/FIO2 ratio less than 300 or SpO2/FiO2 less than 315
  • Signed informed consent by the patient or legal representative
Not Eligible

You will not qualify if you...

  • Moribund with expected survival less than 24 hours
  • Expected survival less than 30 days due to chronic illness prior to COVID-19 infection
  • Not committed to full disease-specific therapy (comfort care allowed)
  • Treatment with immune suppressing medications within the last 30 days (except steroids for ARDS or septic shock)
  • COVID-19 illness presumed longer than 14 days
  • Hospital admission longer than 14 days
  • Deemed unsafe for travel for radiation therapy
  • Chronic hypoxemia requiring supplemental oxygen at baseline
  • Active connective tissue disease (e.g., scleroderma) or idiopathic pulmonary fibrosis
  • Prior radiation therapy causing grade 2 or higher radiation pneumonitis within 365 days
  • Radiation to the chest within 180 days (except skin-only treatments)
  • Known active uncontrolled bacterial or fungal lung infections
  • Active cytotoxic chemotherapy
  • Females who are pregnant or have a positive pregnancy test
  • Breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

A

Arnab Chakravarti

CONTACT

K

Kimberly Mahler

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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