COVID-19Phase 2VENTEDNCT04427566
Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
A Phase 2 study testing Radiation therapy in people with COVID-19, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2020to 26 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
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
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.
Read the detailed description
The primary outcome is the mortality rate 30 days after the ICU-based mechanical ventilation initiation.Based on current data available, the mortality rate for ventilated patients is assumed to be 80% in the current design. An interim futility analysis will be conducted after 16 evaluable patients have received the ultralow dose-whole lung radiation therapy (ULD-WLRT). If at least 3 patients survive for at least 30 days, we will enroll additional 8 patients (total of 24 patients). Otherwise, the trial will stop for further evaluation. Due to the limited data currently available in local institutions about a 30 day mortality rate , we will retrospectively evaluate the mortality rate of the ventilated patients without the ULD-WLRT in our institution when data is available.
Time to event secondary objectives (e.g. overall survival, time to discharge) analyses will be performed using Kaplan-Meier survival analysis, with a competing risk model (leaving the study because of death), including effects for demographic/clinical characteristics in the model. Proportional endpoints (such as % patients off ventilator) will be calculated along with the 95% Clopper-Pearson exact confidence interval. Pre/post measurements will be evaluated using linear mixed models for repeated measures (with proper data transformation as needed). Association between demographic/clinical characteristics and other secondary objectives (size of ground glass opacities (GGO)/opacification, for example) will be accomplished with generalized linear models.
- Conditions
- COVID-19
- Being tested
- Radiation therapy
- Keywords
- ventilator, radiation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Also called Linear accelerator, x-rays, LINAC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 month post radiation dose
Secondary outcomes (9)
To Compare Total Hospital Stay and Length of Hospital Stay After Post Radiation Dose
number of days hospitalized before and after radiation
Measured: Until subject discharged for any reason, up to day 47
Evaluate Total and Post-ULD-WLRT ICU Length of Stay
Number of days in ICU after receiving radiation therapy
Measured: Until subject discharged for any reason, up to day 47
Number of Days Alive After RT in Days
Number of days subject survives Ultra Low Dose-Whole Lung Radiation Therapy, including hospital days and post discharge from hospital until lost to follow-up
Measured: long term follow, up to 277 days
Days of Supplemental Oxygen Therapy
To evaluate total supplemental oxygen therapy
Measured: length of hospital stay, up to day 47
Ventilator-free Days
number of days without mechanical ventilation
Measured: length of subject hospitalization, up to day 47
Oxygenation Index Post RT
Oxygenation index until extubated, for up to 47 days. Oxygenation Index (OI) in medicine (OI = FiO2 x MAP x100/ PaO2) assesses severe lung injury, with higher numbers meaning worse function. This is expressed as a fraction, with no units and is not a percentage
A normal Oxygenation Index (OI) measures the severity of respiratory failure. The ratio is for a healthy peron is 25 and lower. Oxygenation Index values of 25-40 indicate high mortality,
Definitions: Mean Airway Pressure (MAP); FiO2 (Fraction of Inspired Oxygen) is the concentration or percentage of oxygen a patient breathes; PaO2 (Partial pressure of oxygen) is a measurement from an Arterial Blood Gas (ABG) test that shows the pressure of oxygen dissolved in your arterial blood
Measured: length of hospitalization, up to 47 days
Differences Between Ground Glass Opacities (GGO), Lung Infiltrates and Opacification Percentage
Quantitate post-ULD-WLRT the baseline and Day 7, 14, and 28 CT chest findings ( total number of GGO, lung infiltrates and opacification) and the percentage of each chest finding (GGO, lung infiltrates and opacification) found in a CT scan image.
Measured: assessed at day 0, 7, 14, and 28 post radiation
Viral Titers at Days 0, 1 7, 14 and 28 Post RT
Evaluate SARS-CoV2 viral titers at baseline and post Ultra Low Dose-Whole Lung Radiation Therapy (ULD-WLRT) at Day 0, 1, 7, 14, and 28
Measured: assessed at days 0, 1, 7, 14 and 28 days post radiation
Tolerability of Regimen
Establish safety and tolerability using number of days of survival
Measured: up to 9 months post radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start23 Jul 2020
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Why it stopped: there were very few patients using ventilators, so it was impossible to enroll additional subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnab Chakravarti, Ohio State University
- Investigators
- Arnab Chakravarti, Principal investigator, James Cancer Hospital, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427566
- Sponsor's protocol ID
- VENTED
- Acronym
- VENTED
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2020
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32171076Chen 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.
PubMed 32007143Calabrese 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.
PubMed 24348219Rodel 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.
PubMed 17487675Schaue 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.
PubMed 16368644Shi 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.
PubMed 32105637Calabrese 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.
PubMed 31060383
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04427566
- Acronym / sponsor ID
- VENTED / VENTED
- Conditions
- COVID-19
- Keywords
- ventilator, radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: there were very few patients using ventilators, so it was impossible to enroll additional subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 19 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary outcome is the mortality rate 30 days after the ICU-based mechanical ventilation initiation.Based on current data available, the mortality rate for ventilated patients is assumed to be 80% in the current design. An interim futility analysis will be conducted after 16 evaluable patients have received the ultralow dose-whole lung radiation therapy (ULD-WLRT). If at least 3 patients survive for at least 30 days, we will enroll additional 8 patients (total of 24 patients). Otherwise, the trial will stop for further evaluation. Due to the limited data currently available in local institutions about a 30 day mortality rate , we will retrospectively evaluate the mortality rate of the ventilated patients without the ULD-WLRT in our institution when data is available.
Time to event secondary objectives (e.g. overall survival, time to discharge) analyses will be performed using Kaplan-Meier survival analysis, with a competing risk model (leaving the study because of death), including effects for demographic/clinical characteristics in the model. Proportional endpoints (such as % patients off ventilator) will be calculated along with the 95% Clopper-Pearson exact confidence interval. Pre/post measurements will be evaluated using linear mixed models for repeated measures (with proper data transformation as needed). Association between demographic/clinical characteristics and other secondary objectives (size of ground glass opacities (GGO)/opacification, for example) will be accomplished with generalized linear models.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Arm | Experimental | Radiation: Radiation therapyEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyAlso: Linear accelerator, x-rays, LINACPatients 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. | Radiation | Radiation Arm |
Primary outcome
Mortality Rate of Subjects Treated With Whole Lung Low-dose Radiation.
Time frame: up to 1 month post radiation dose
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
9 secondary outcomes
To Compare Total Hospital Stay and Length of Hospital Stay After Post Radiation Dose
Time frame: Until subject discharged for any reason, up to day 47
Evaluate Total and Post-ULD-WLRT ICU Length of Stay
Time frame: Until subject discharged for any reason, up to day 47
Number of Days Alive After RT in Days
Time frame: long term follow, up to 277 days
Days of Supplemental Oxygen Therapy
Time frame: length of hospital stay, up to day 47
Ventilator-free Days
Time frame: length of subject hospitalization, up to day 47
Oxygenation Index Post RT
Time frame: length of hospitalization, up to 47 days
Differences Between Ground Glass Opacities (GGO), Lung Infiltrates and Opacification Percentage
Time frame: assessed at day 0, 7, 14, and 28 post radiation
Viral Titers at Days 0, 1 7, 14 and 28 Post RT
Time frame: assessed at days 0, 1, 7, 14 and 28 days post radiation
Tolerability of Regimen
Time frame: up to 9 months post radiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32171076Zhou 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.
- Background: PubMed 32007143Chen 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.
- Background: PubMed 24348219Calabrese 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.
- Background: PubMed 17487675Rodel 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.
- Background: PubMed 16368644Schaue 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.
- Background: PubMed 32105637Shi 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.
- Background: PubMed 31060383Calabrese 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnab Chakravarti principal investigator
James Cancer Hospital, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation therapy in people with COVID-19, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate of Subjects Treated With Whole Lung Low-dose Radiation. (time frame: up to 1 month post radiation dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427566, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.