Lung Irradiation for COVID-19 Pneumonia
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ClinicalTrials.gov Identifier: NCT04393948 |
Recruitment Status :
Withdrawn
(Lack of accrual)
First Posted : May 19, 2020
Last Update Posted : February 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV 2 | Radiation: Phase 1 Radiation: Phase 2 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study of Low-Dose Single or Bilateral Whole Lung Irradiation for SARS-CoV-2 Pneumonia |
Actual Study Start Date : | June 19, 2020 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: No irradiation |
Radiation: Phase 2
Arm A - No irradiation |
Experimental: 100 cGy single lung irradiation
100 cGy single lung radiation
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Radiation: Phase 1
Dose Level 1 - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator Radiation: Phase 2 Arm B - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator |
Experimental: 100 cGy bilateral lung irradiation
100 cGy bilateral lung radiation
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Radiation: Phase 1
Dose Level 2 - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator Radiation: Phase 2 Arm C - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator |
- Phase 1: Feasibility and safety of treating hospitalized patients with SARS-CoV-2 pneumonia with single or bilateral whole lung irradiation [ Time Frame: 4 days after randomization ]Subjects will be treated with 100 cGy irradiation to a single (right-sided) lung (dose level 1) or 100 cGy irradiation to both lungs (dose level 2) following a 3 + 3 dose escalation scheme
- Phase 2: Proportion with clinical improvement on a 7-point ordinal scale on day 4 after randomization [ Time Frame: 4 days after randomization ]
The ordinal scale is an assessment of the clinical status on a given day. Each day, the worst (lowest) score from the previous day will be recorded as the score for that previous day.
The scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring low flow supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care
- Not hospitalized
- Improvement or worsening on the 7-point ordinal scale over additional intervals [ Time Frame: Up to 30 days after randomization ]
- Rate and duration of use of supplemental oxygen [ Time Frame: Up to 30 days after randomization ]
- Rate and duration of fever > 38ºC [ Time Frame: Up to 30 days after randomization ]
- Rate and duration of invasive mechanical ventilation [ Time Frame: Up to 30 days after randomization ]
- Duration of hospitalization [ Time Frame: Up to 30 days after randomization ]
- Proportion of participants with overall survival up to 30 days after randomization [ Time Frame: Up to 30 days after randomization ]
- Improvement in radiographic findings related to infection/inflammation; comparisons include on study versus baseline scans and irradiated vs. unirradiated lung in subjects randomized to receive single lung irradiation [ Time Frame: Up to 30 days after randomization ]
- Treatment-emergent adverse events [ Time Frame: Up to 30 days after randomization ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria
- Diagnosis of SARS-CoV-2 infection by RT-PCR or another approved laboratory test ≤ 3 days before enrollment or ≤ 14 days before enrollment with progressive disease suggestive of ongoing SARS-CoV-2 infection; retesting allowed
- Current hospitalization for ≤ 14 days with SARS-CoV-2 infection at the time of enrollment
- Use of supplemental oxygen or oxygen saturation ≤ 94% on room air
- Age ≥ 40
- May receive antiviral medication (e.g., remdesivir, lopinavir/ritonavir, oseltamivir, favipiravir), antibiotics (e.g., azithromycin), chloroquine, hydroxychloroquine, corticosteroids, statins, anticoagulation, antiplatelet agents (e.g., aspirin) and/or convalescent plasma from recovered individuals off study and/or on study if permitted by the other protocol
Exclusion criteria
- Prior or planned treatment with interleukin inhibitors (e.g., tocilizumab, canakinumab, sarilumab) or TNF-α inhibitors within 14 days of enrollment
- Prior lobectomy or pneumonectomy
- Prior thoracic radiotherapy with cumulative lung V20 > 15% to either lung within 1 year of enrollment, or any radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment
- Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radiosensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin or gemcitabine
- Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment
- Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class ≥ 3 congestive heart failure
- History of bone marrow or solid organ transplantation
- Known history of autoimmune collagen vascular disease, e.g., scleroderma
- Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia
- Pregnancy
- Inability to be positioned supine and flat for radiation planning and delivery
- Inability to provide informed consent or lack of an authorized representative who can provide informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393948
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | David Kozono, MD, PhD | Brigham and Women's Hospital |
Responsible Party: | David E. Kozono, Associate Radiation Oncologist, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT04393948 |
Other Study ID Numbers: |
2020P001494 |
First Posted: | May 19, 2020 Key Record Dates |
Last Update Posted: | February 4, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
SARS-CoV-2 Radiation Therapy COVID-19 |
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |