Trial Outcomes & Findings for Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise (NCT NCT04427566)
NCT ID: NCT04427566
Last Updated: 2026-08-19
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
up to 1 month post radiation dose
Results posted on
2026-08-19
Participant Flow
Participant milestones
| Measure |
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.
Radiation therapy: 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.
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|---|---|
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
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.
Radiation therapy: 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.
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|---|---|
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Overall Study
deemed ineligle
|
1
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Baseline Characteristics
Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
Baseline characteristics by cohort
| Measure |
Radiation Arm
n=2 Participants
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 therapy: 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=298 Participants
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Age, Categorical
Between 18 and 65 years
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2 Participants
n=298 Participants
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Age, Categorical
>=65 years
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0 Participants
n=298 Participants
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Sex: Female, Male
Female
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1 Participants
n=298 Participants
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Sex: Female, Male
Male
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1 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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1 Participants
n=298 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=298 Participants
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PRIMARY outcome
Timeframe: up to 1 month post radiation dosePopulation: subjects who received 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
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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Mortality Rate of Subjects Treated With Whole Lung Low-dose Radiation.
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0 participants
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SECONDARY outcome
Timeframe: Until subject discharged for any reason, up to day 47number of days hospitalized before and after radiation
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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To Compare Total Hospital Stay and Length of Hospital Stay After Post Radiation Dose
total length of hospital stay
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47 days
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To Compare Total Hospital Stay and Length of Hospital Stay After Post Radiation Dose
length of hospital stay after radiation
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45 days
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SECONDARY outcome
Timeframe: Until subject discharged for any reason, up to day 47Number of days in ICU after receiving radiation therapy
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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Evaluate Total and Post-ULD-WLRT ICU Length of Stay
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40 days
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SECONDARY outcome
Timeframe: long term follow, up to 277 daysPopulation: one subject received a single dose of radiation
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
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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Number of Days Alive After RT in Days
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277 days
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SECONDARY outcome
Timeframe: length of hospital stay, up to day 47To evaluate total supplemental oxygen therapy
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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Days of Supplemental Oxygen Therapy
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47 days
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SECONDARY outcome
Timeframe: length of subject hospitalization, up to day 47number of days without mechanical ventilation
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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Ventilator-free Days
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6 days
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SECONDARY outcome
Timeframe: length of hospitalization, up to 47 daysOxygenation 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
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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Oxygenation Index Post RT
Baseline
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8.85 oxygen index (OI)
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Oxygenation Index Post RT
Day 1 Post RT
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7.59 oxygen index (OI)
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Oxygenation Index Post RT
Day 3 Post RT
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9.93 oxygen index (OI)
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Oxygenation Index Post RT
Day 5 post RT
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11.51 oxygen index (OI)
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Oxygenation Index Post RT
Day 7 post RT
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15.69 oxygen index (OI)
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Oxygenation Index Post RT
Day 9 post RT
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17.5 oxygen index (OI)
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Oxygenation Index Post RT
Day 11 post RT
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12.51 oxygen index (OI)
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Oxygenation Index Post RT
Day 14 post RT
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14.73 oxygen index (OI)
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Oxygenation Index Post RT
Day 16 post RT
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12.39 oxygen index (OI)
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Oxygenation Index Post RT
Day 18 post RT
|
10.72 oxygen index (OI)
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Oxygenation Index Post RT
Day 20 post RT
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9.66 oxygen index (OI)
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Oxygenation Index Post RT
Day 22 post RT
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6.6 oxygen index (OI)
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Oxygenation Index Post RT
Day 24 post RT
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5.28 oxygen index (OI)
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Oxygenation Index Post RT
Day 26 post RT
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2.61 oxygen index (OI)
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Oxygenation Index Post RT
Day 28 post RT
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2.4 oxygen index (OI)
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SECONDARY outcome
Timeframe: assessed at day 0, 7, 14, and 28 post radiationQuantitate 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at days 0, 1, 7, 14 and 28 days post radiationEvaluate 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 9 months post radiationEstablish safety and tolerability using number of days of survival
Outcome measures
| Measure |
Radiation Arm
n=1 Participants
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 therapy: 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.
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|---|---|
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Tolerability of Regimen
|
277 days
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OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at days 0, 1, 7, 14, and 28Molecular biomarker levels in COVID-19 patients upfront as well as after treatment with Ultra Low Dose-Whole Lung Radiation Therapy (ULD-WLRT) such as levels or inflammatory and DNA damage markers).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: during hospitalization, on day 1 prior to radiationDetermine baseline molecular biomarkers that predict response to Ultra Low Dose-Whole Lung Radiation Therapy (ULD-WLRT) in COVID-19 patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: during hospitalization, on days 0, 1, 7, 14, and 28Determine molecular biomarkers that change over the treatment course, correlating with disease status and resolution.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: day of radiation treatmentRetrospectively evaluate rapidly planned treatment using volumetric treatment plan evaluation based on Cone Beam CT (CBCT)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 277 days post treatmentcomparison of raw diagnostic and CBCT imaging data for machine-learning assessment of longitudinal progression in patients with COVID-19
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: imaging prior to radiationCollect raw imaging data for further evaluation of the potential for identification of COVID-19 in diagnostic scans
Outcome measures
Outcome data not reported
Adverse Events
Radiation Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation Arm
n=1 participants at risk
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 therapy: 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.
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|---|---|
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Metabolism and nutrition disorders
hypokalemia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Respiratory, thoracic and mediastinal disorders
hypoxia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Vascular disorders
capillary leak syndrome
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100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Vascular disorders
hypotension
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100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Renal and urinary disorders
acute kidney injury
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100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Other adverse events
| Measure |
Radiation Arm
n=1 participants at risk
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 therapy: 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.
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|---|---|
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Gastrointestinal disorders
nausea
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Gastrointestinal disorders
vomiting
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Renal and urinary disorders
urinary retention
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Gastrointestinal disorders
diarrhea
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100.0%
1/1 • Number of events 2 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Gastrointestinal disorders
abdominal pain
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Gastrointestinal disorders
Cholelithiasis
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
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Respiratory, thoracic and mediastinal disorders
voice alteration
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
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Musculoskeletal and connective tissue disorders
back pain
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
orthopenia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
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Psychiatric disorders
insomnia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
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Musculoskeletal and connective tissue disorders
head wound
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Vascular disorders
hypotension
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Psychiatric disorders
delerium
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Vascular disorders
capillary leak syndrome
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Metabolism and nutrition disorders
hypokalemia
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Vascular disorders
hematoma
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Investigations
decreased platelet count
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Investigations
increased alkaline phosphatase
|
100.0%
1/1 • Number of events 3 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Blood and lymphatic system disorders
anemia
|
100.0%
1/1 • Number of events 3 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
General disorders
trace edema
|
100.0%
1/1 • Number of events 2 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Investigations
increased creatinine
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Renal and urinary disorders
proteinuria
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Investigations
decreased lymphocyte count
|
100.0%
1/1 • Number of events 6 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Musculoskeletal and connective tissue disorders
pain
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
|
Infections and infestations
infection, bronchial
|
100.0%
1/1 • Number of events 1 • Adverse Events were collected after administration of radiation, until 9 months post treatment. Patient then moved and was lost to followup for the 1 year evaluation.
|
Additional Information
Dr. Chakravarti
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-0672
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place