Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- blood oxygen saturation level
研究概览
简要总结
The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU
详细描述
The WHO has officially confirmed that: "Currently, there is no specific pharmacological available treatment for COVID-19".
Beyond vital support, there are not currently treatment options for Coronavirus disease (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19 pneumonia and could be available quickly and with a duration of about 15 minutes of treatment.
Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was the only effective mean to treat certain infectious and inflammatory diseases prior to the development of antimicrobial therapies in the 1940s.
The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for viral pneumonia with great success. It will be administered for a new disease, pneumonia caused by COVID-19, for which there is no cure and many people are dying, mainly from severe acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure refractory to treatment.
This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and it also has a low risk of side effects and toxicities, given the low doses received, more than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 65 years old
- •Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined by the presence of ALL the following characteristics:
- •Presence of unilateral or bilateral pulmonary infiltrates in chest X-ray or computed tomography (CT).
- •Acute respiratory failure expressed by PaO2 / FIO2 <
- •Lymphopenia ≤0.8 × 109 / L (800 lymphocytes / ml).
- •Patients with ≤8 days from the onset of symptoms.
排除标准
- •Patient not consent to participate
结局指标
主要结局
blood oxygen saturation level
时间窗: 48 hours
Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels
Torax X-ray
时间窗: 48 hours
radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
次要结局
- Hospitalization(2 months)
- Mortality(3 months)
- days free of assisted mechanical respiration(3 month)
研究者
Carlos Ferrer Albiach
MD
Hospital Provincial de Castellon