Status:
WITHDRAWN
Lung Irradiation for COVID-19 Pneumonia
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
SARS-CoV 2
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
In this research study the investigators want to learn more about the potential benefit of radiation to the lung to improve the health of patients who are hospitalized with Coronavirus-19 (COVID-19) d...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04393948
Start Date
June 19 2020
End Date
September 1 2021
Last Update
February 4 2022
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115