跳至主要内容
临床试验/CTRI/2021/05/033883
CTRI/2021/05/033883尚未招募2 期

Bilateral Whole lung Irradiation as a Novel treatment for COVID-19 induced acute respiratory distress syndrome(ARDS)

Surya Global Multi Speciality Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Adult patients with RT-PCR proven COVID-19 with moderate to severe pneumonia with fewer than 14 days of symptom onset that
  • warranted hospitalization and currently receiving standard medication for COVID-19 at appropriate doses which would include,among others, antivirals, corticosteroids, or anti-IL-6 tocilizumab.and
  • 2. moderate to severe dyspnoea, respiratory frequency equal to or greater than 30/min, oxygen saturation without supplemental O2
  • supply SpO2 94% or less, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio 315 or less if PaO2 is not available
  • 3. laboratory abnormalities such as C-reactive protein >100 mg/L or D-dimer >1000 ng/ml or IL-6 >50 IU or suspected cytokine release

排除标准

  • 1. Patients on ventilators (invasive/non invasive)
  • 2. Prior lobectomy or pneumonectomy
  • 3. Prior thoracic radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment
  • 4. Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radio sensitization within 14 days or 5 half-lives,
  • whichever is greater, of enrollment, e.g., bleomycin, gemcitabine
  • 5. Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment
  • 6. Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class 3 (or higher) congestive heart failure
  • 7. History of bone marrow or solid organ transplantation
  • 8. Known history of autoimmune collagen vascular disease, e.g.,scleroderma
  • 9. Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia
  • 10. Pregnancy
  • 11. Inability to be positioned supine and flat for radiation planning and delivery
  • 12. Inability to provide informed consent or lack of an authorized representative who can provide informed consent

研究者

发起方
Surya Global Multi Speciality Hospital

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