Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%
研究概览
简要总结
Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients.
Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.
详细描述
Study design: This is a prospective multicenter study in 2 phases:
- Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum efficiency of 30% is not achieved, the study will not be continued.
- Comparative phase in two groups, a control group, which will only receive pharmacological treatment, and an experimental one. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm, which will receive low-dose lung irradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years old
- •Moderate to severe COVID-19 pneumonia with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses
- •PAFIO2 of less than 300 mmHg or SaFI02 <315 mmHg
- •Patients who are not candidates for admission to the Intensive Care Unit due to age, concomitant diseases or general condition.
- •One of the following conditions:
- •or IL6 greater than 40
- •or PCR> 100mg / l
- •D-dimer greater than 1500ng / ml
- •Suspected cytokine release syndrome
- •Have read the information sheet and signed the informed consent
排除标准
- •Age <18 years
- •Failure to meet the inclusion criteria
- •Leukopenia <1000
- •Pregnancy
- •Not understanding or refusing the purpose of the study
研究组 & 干预措施
Control group
a control group only receive pharmacological treatment
干预措施: Hydroxychloroquine Sulfate (Drug)
Control group
a control group only receive pharmacological treatment
干预措施: Ritonavir/lopinavir (Drug)
Control group
a control group only receive pharmacological treatment
干预措施: Tocilizumab Injection [Actemra] (Drug)
Control group
a control group only receive pharmacological treatment
干预措施: Azithromycin (Drug)
Control group
a control group only receive pharmacological treatment
干预措施: Corticosteroid (Drug)
Control group
a control group only receive pharmacological treatment
干预措施: Low molecular weight heparin (Drug)
Control group
a control group only receive pharmacological treatment
干预措施: Oxygen supply (Device)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Low-dose radiotherapy (Radiation)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Hydroxychloroquine Sulfate (Drug)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Ritonavir/lopinavir (Drug)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Tocilizumab Injection [Actemra] (Drug)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Azithromycin (Drug)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Corticosteroid (Drug)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Low molecular weight heparin (Drug)
Experimental group
an experimental group will receive low-dose lung irradiation
干预措施: Oxygen supply (Device)
结局指标
主要结局
Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%
时间窗: Day 2 after interventional radiotherapy
To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. . In cases of impossibility the SaFiO2 will be determined
次要结局
- Change of the radiological image(Days 7 and day 30 after interventional radiotherapy)
- Overall mortality(Day 15 and Day 30 after interventional radiotherapy)
- Measure of trasforming growth factor (TGF-b)(Days 1, day 4 and day 7 after interventional radiotherapy)
- Determining overexpression of pro-inflammatory selectin(Days 1, day 4 and day 7 after interventional radiotherapy)
- Measure of marker of oxidative stress PON-1(Days 1, day 4 and day 7 after interventional radiotherapy)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Day 30 and day 90 after interventional radiotherapy)
- Measure of pro-inflammatory interleukins(Days 1, day 4 and day 7 after interventional radiotherapy)
- Measure of tumor necrosis factor alpha (TNF-a)(Days 1, day 4 and day 7 after interventional radiotherapy)
- Determining cell adhesion molecules (CAMs)(Days 1, day 4 and day 7 after interventional radiotherapy)