RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-07-23

Study Completion:2021-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04427566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Arnab Chakravarti

CONTACT

614-293-0672

Arnab.Chakravarti@osumc.edu

Kimberly Mahler

CONTACT

614-685-4247

kimberly.mahler@osumc.edu

Principal Investigator

Arnab Chakravarti

PRINCIPAL_INVESTIGATOR

James Cancer Hospital, Department of Radiation Oncology

Study Locations (Sites)

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

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

Arnab Chakravarti, PRINCIPAL_INVESTIGATOR, James Cancer Hospital, Department of Radiation Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-23

Study Completion Date2021-12-31

Study Record Updates

Study Start Date2020-07-23

Study Completion Date2021-12-31

Terms related to this study

Keywords Provided by Researchers

ventilator
radiation

Additional Relevant MeSH Terms

COVID-19