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

NCT04427566 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: VENTED
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

ventilator; radiation

Outcome Measures

Primary Outcomes (1)

• Mortality rate of subjects treated with whole lung low-dose radiation

  Death date of subjects will be collected from the date of radiation up to 1 month post radiation dose

  up to 28 days post radiation delivery

Secondary Outcomes (9)

• Survival rate of subjects treated with whole lung low-dose radiation

  up to 18 months post radiation delivery

• Change in number of Intensive care unit days

  up to 28 days post radiation delivery

• Change in number of days using supplemental oxygen

  up to 28 days post radiation delivery

• Change in oxygenation index/oxygen saturation index for 14 days post treatment or until extubated

  up to 28 days post radiation

• Quantitation of Lung Involvement using Chest CT

  up to 28 days post radiation

Study Arms (1)

Radiation Arm

EXPERIMENTAL

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.

Radiation: Radiation therapy

Interventions

Radiation therapy RADIATION

Patients 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.

Also known as: Linear accelerator, x-rays, LINAC

Radiation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (7)

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Calabrese EJ, Dhawan G. How radiotherapy was historically used to treat pneumonia: could it be useful today? Yale J Biol Med. 2013 Dec 13;86(4):555-70.

  PMID: 24348219 BACKGROUND

• Rodel F, Keilholz L, Herrmann M, Sauer R, Hildebrandt G. Radiobiological mechanisms in inflammatory diseases of low-dose radiation therapy. Int J Radiat Biol. 2007 Jun;83(6):357-66. doi: 10.1080/09553000701317358.

  PMID: 17487675 BACKGROUND

• Schaue D, Jahns J, Hildebrandt G, Trott KR. Radiation treatment of acute inflammation in mice. Int J Radiat Biol. 2005 Sep;81(9):657-67. doi: 10.1080/09553000500385556.

  PMID: 16368644 BACKGROUND

• Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.

  PMID: 32105637 BACKGROUND

• Calabrese EJ, Dhawan G, Kapoor R, Kozumbo WJ. Radiotherapy treatment of human inflammatory diseases and conditions: Optimal dose. Hum Exp Toxicol. 2019 Aug;38(8):888-898. doi: 10.1177/0960327119846925. Epub 2019 May 6.

  PMID: 31060383 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Radiotherapy; Particle Accelerators; X-Rays

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiation Equipment and Supplies; Equipment and Supplies; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Arnab Chakravarti

  James Cancer Hospital, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnab Chakravarti

CONTACT

614-293-0672; Arnab.Chakravarti@osumc.edu

Kimberly Mahler

CONTACT

614-685-4247; kimberly.mahler@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: July 23, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)