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

NCT04427566 | Terminated Phase 2 Results DMC FDA Device

• 1 other identifier: VENTED
• Study Type: interventional
• Target: 2
• 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.

  Number of subjects who expire from the date of radiation up to 1 month post radiation dose. The date will be collected if subject expires

  up to 1 month post radiation dose

Secondary Outcomes (9)

• To Compare Total Hospital Stay and Length of Hospital Stay After Post Radiation Dose

  Until subject discharged for any reason, up to day 47

• Evaluate Total and Post-ULD-WLRT ICU Length of Stay

  Until subject discharged for any reason, up to day 47

• Number of Days Alive After RT in Days

  long term follow, up to 277 days

• Days of Supplemental Oxygen Therapy

  length of hospital stay, up to day 47

• Ventilator-free Days

  length of subject hospitalization, up to day 47

Other Outcomes (6)

• Molecular Markers

  assessed at days 0, 1, 7, 14, and 28

• Baseline Molecular Biomarkers

  during hospitalization, on day 1 prior to radiation

• Molecular Biomarker Level

  during hospitalization, on days 0, 1, 7, 14, and 28

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: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

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

Limitations and Caveats

Difficult to enroll patients to the study due to their delicate medical state and population limitations. The number of eligible patients on ventilators decreased after first year of study.

Results Point of Contact

• Title: Dr. Chakravarti
• Organization: The Ohio State University Comprehensive Cancer Center

arnab.chakravarti@osumc.edu

614-293-0672

Study Officials

• Arnab Chakravarti

  James Cancer Hospital, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: August 19, 2026
• Results First Posted: August 19, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)