Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
Recruiting
Phase 2Interventional Study
COVID-19
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Ohio State University Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for patients with COVID-19 pneumonia who need help breathing. Participants will receive a treatment using low-dose radiation to reduce lung inflammation.
Are You a Good Fit for This Trial?
Rules you outActive uncontrolled infectionPregnancyBreastfeeding
You may be able to join if
I have been diagnosed with COVID-19 within the last 14 days
I have typical signs of COVID-19 pneumonia on a scan
I am receiving mechanical ventilation in an ICU
I am expected to live for at least 24 hours
I have low oxygen levels defined by specific measurements
I have signed consent or my representative has signed for me
You may not be able to join if
I am expected to live for less than 24 hours
I have a life expectancy of less than 30 days due to other illness
I am not committed to receiving full treatment for my illness
I have taken immune suppressing medications in the last 30 days
I have had COVID-19 for more than 14 days
I have been in the hospital for more than 14 days
I cannot safely travel for the radiation treatment
I have an active uncontrolled infection in my lungs
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 inflamma…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Laboratory Diagnosis of COVID-19 based within 14 days of enrollment.
* CT or radiographic findings typical of COVID-19 pneumonia within 5 days of enrollment
* Receiving ICU-based mechanical ventilation
* Life expectancy ≥ 24 hours, as judged by investigator
* Hypoxemia defined…
Inclusion Criteria:
* Laboratory Diagnosis of COVID-19 based within 14 days of enrollment.
* CT or radiographic findings typical of COVID-19 pneumonia within 5 days of enrollment
* Receiving ICU-based mechanical ventilation
* Life expectancy ≥ 24 hours, as judged by investigator
* Hypoxemia defined as a Pa/FIO2 ratio \< 300 or SpO2/FiO2 \< 315
* Signed informed consent by patient or his or her legal/authorized representative
Exclusion Criteria:
* Moribund with survival expected \< 24 hours, as judged by investigator and treating team
* Expected survival \< 30 days, as judged by investigator and treating team, due to chronic illness present prior to COVID infection
* Patient or legal representative not committed to full disease specific therapy, i.e. comfort care (DNRCCA is allowed)
* Treatment with immune suppressing medications in the last 30 days (steroids for acute respiratory distress syndrome or septic shock allowed)
* Presumed COVID-associated illness greater than 14-days
* Inpatient admission greater than 14-days
* Patient deemed unsafe for travel for radiation therapy
* Chronic hypoxemia requiring supplemental oxygen at baseline
* Documented active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
* History of prior radiation therapy resulting in ≥grade 2 radiation pneumonitis within 365 days of enrollment
* Active or history of prior radiation to the thorax completed within 180 days of enrollment (skin or surface only skin treatments are acceptable)
* Known active uncontrolled bacterial or fungal infections of the lung.
* Active cytotoxic chemotherapy
* Females who are pregnant or have a positive pregnancy test
* Breast feeding
* Note: concurrent administration of convalescent immune plasma therapy either on clinical trial or as a standard therapy not an exclusion criterion, but will be noted
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.