Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Ventilator free days (VFD)
研究概览
简要总结
This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).
详细描述
Management of patients with SARS-CoV-2 presents a great challenge in the ongoing pandemic. The inflammatory reaction, evident in the later stages of the disease, is linked with high mortality rates. Pharmaceutical interventions at this stage often do not achieve the desired effects. Low Dose Radiation Therapy (LD-RT) has been utilized for treatment of inflammatory conditions because of its immunomodulatory effects. Thus, LD-RT may be an option in SARS-CoV-2 based on pre-clinical models and early clinical data. This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Information on group allocation will not be disclosed to either the patient or the ICU-staff.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of male patients >40 years
- •Age of female patients >50 years
- •Patients with SARS-CoV-2 requiring mechanical ventilation
- •Informed consent obtained by the legal representative of the patient
排除标准
- •Pregnancy
结局指标
主要结局
Ventilator free days (VFD)
时间窗: at day 15 after LD-RT
Ventilator free days (VFD)
次要结局
- Change in levels of white blood cell counts (number of white blood cells per volume of blood)(up to day 15 after LD-RT)
- Overall mortality(at day 15 and 28 after LD-RT)
- Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)(at day 5, 10, 15, 28 after LD-RT)
- Change in levels of ferritin (ng/ml)(up to day 15 after LD-RT)
- Change in levels of c-reactive protein (mg/l)(up to day 15 after LD-RT)