Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Study ID
- NCT04427566
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Radiation therapy — RADIATIONPatients will be treated with a single dose of 80 cGy to the bilateral lungs in a manner that is simplified such that it can be designed and delivered quickly in one session. No specific normal tissue constraints are employed in this protocol.
Study Details
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.
Key Dates
- Start date
- Jul 23, 2020
- Status verified
- Mar 2021
- Primary completion
- Dec 31, 2021
- Completion
- Dec 31, 2021
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Radiation ArmEach subject will receive a dose of whole lung radiation. A second optional dose of 80 cGy may be delivered if no improvement after 3-10 days.
Primary Outcome Measure
Mortality rate of subjects treated with whole lung low-dose radiation [ Time Frame: up to 28 days post radiation delivery ]
Central Contacts
- Arnab Chakravarti614-293-0672
- Kimberly Mahler614-685-4247
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | Arnab Chakravarti, MD (PRINCIPAL_INVESTIGATOR) |
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