Vented COVID: A Phase II Study Of The Use Of Ultra Low-Dose Bilateral Whole Lung Radiation Therapy in the Treatment Of Critically Ill Patients With COVID-19 Respiratory Compromise

Who is this study for? Critically ill patients with COVID-19 respiratory compromise
What treatments are being studied? Radiation therapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
RECRUITING
Columbus
Contact Information
Primary
Arnab Chakravarti
Arnab.Chakravarti@osumc.edu
614-293-0672
Backup
Kimberly Mahler
kimberly.mahler@osumc.edu
614-685-4247
Time Frame
Start Date: 2020-07-23
Estimated Completion Date: 2021-12-31
Participants
Target number of participants: 24
Treatments
Experimental: Radiation Arm
Each 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.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov