Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis
试验速览
- 阶段
- 不适用
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Radiological response
研究概览
简要总结
SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality.
The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of LD-RT for SARS-CoV-2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years.
- •COVID19 + confirmed by PCR.
- •Thoracic imaging study (chest X-ray, chest CT or PET-CT), compatible with lung involvement.
- •Phase II or lung phase without any improvement with pharmacological treatment.
- •Phase III or hyper-inflammatory phase without any improvement with pharmacological treatment
- •Poor clinical and functional respiratory evolution: > 30 breaths / minute, SpO2 <93%, PaO2 / FiO2 <
- •D-dimer> 1000 ng / mL or rising, ferritin> 1000 ng / mL, PCR> 10 mg / dL or double than before.
排除标准
- •Severe comorbidities that could hamper the radiation treatment.
结局指标
主要结局
Radiological response
时间窗: 7 days after low dose radiation
Radiological results: Radiological worsening, improvement or without significant changes
次要结局
- Adverse events(1 year)
- SPO2 and PaO2/FiO2(7 days)
- blood cell count(3 days after low dose radiation)
- Remission of respiratory symptoms(up to 6 months)
- Overall survival(1 month)
- Ferritin value(3 days after low dose radiation)
- Hospitalization(3 months)
- C-reactive protein(3 days after low dose radiation)
- D-dimer(3 days after low dose radiation)
- LDH levels(3 days after low dose radiation)
研究者
Manuel Gonzalo Vázquez Masedo
MD, PhD
Hospital San Carlos, Madrid