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
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