Lung Irradiation for COVID-19 Pneumonia

  • STATUS
    Recruiting
  • participants needed
    48
  • sponsor
    Brigham and Women's Hospital
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Updated on 16 February 2024
See if I qualify
cancer
corticosteroids
aspirin
antiviral drugs
pneumonia
oximetry
azithromycin
chloroquine
SARS
ritonavir
hydroxychloroquine
oseltamivir
coronavirus infection
lopinavir
lopinavir/ritonavir
remdesivir
favipiravir
low dose radiation therapy
azithormycin
acute respiratory syndrome (sars)

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) due to infection with a virus called SARS-CoV-2. This infection causes inflammation of the lung, which can make it difficult to breathe. As a result, patients may need supplemental oxygen or be placed on a ventilator. The investigators believe that low dose radiation therapy to the lung may reduce this inflammation and increase the likelihood that patients will need less oxygen support such as ventilation or supplemental oxygen, or be discharged from the hospital in fewer days, compared to without radiation therapy. The amount of radiation is much lower than what is typically used to treat other conditions such as cancer, although it is higher than the dose used for routine medical imaging.

Details
Condition SARS-CoV 2
Age 40years - 100years
Treatment Phase 1, Phase 2
Clinical Study IdentifierNCT04393948
SponsorBrigham and Women's Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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- 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
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cancer
corticosteroids
aspirin
antiviral drugs
pneumonia
oximetry
azithromycin
chloroquine
SARS
ritonavir
hydroxychloroquine
oseltamivir
coronavirus infection
lopinavir
lopinavir/ritonavir
remdesivir
favipiravir
low dose radiation therapy
azithormycin
acute respiratory syndrome (sars)

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