Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Oxygen Therapy Status at Day 2
研究概览
简要总结
The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients.
In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy.
The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.
详细描述
The exceedingly high mortality rates of severe and critical COVID-19 warrant the evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. In this context, is proposes a prospective multicenter study. It will include 15 patients, to assess the feasibility and efficacy of low-dose lung irradiation in COVID-19 pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years-old.
- •Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.
- •Charlson Comorbidity Index (CCI) less than 6 score.
- •Poor or no response to standard medical treatment, based on:
- •*% Sat02 <93%
- •Oxygen therapy escalation (Understanding from less to more need for support: Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)
- •Pa02 / Fi02 (blood gas analysis) <300 mmHg
- •1 or more inflammatory and immunological analytical parameters such as lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen with values above the normal range, except lymphocytes.
- •Radiological impairment defined as worsening of TSS throughout admission or score at admission: TSS> 5 by a diagnostic baseline CT scan.
- •Eastern Cooperative Oncology Group (ECOG) Status < or = 3
- •Life expectancy (LE)> 1 month at hospital admission for COVID-19
- •No previous thoracic RT (relative-individualization criteria) or chemotherapy (chemoinduced pulmonary toxicity, eg Bleomycin).
- •Verbal information on the procedure, objective and secondary effects, acceptance and signing of informed consent by the patient or legal guardian.
排除标准
- •Failure to meet the inclusion criteria.
- •Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.
- •Patients admitted in ICU.
- •Refusal of treatment after verbal information.
研究组 & 干预措施
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Low molecular weight heparin (Drug)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Ultra-Low-dose radiotherapy (Radiation)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: ventilatory support with oxygen therapy (Device)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Lopinavir/ritonavir (Drug)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Hydroxychloroquine (Drug)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Azithromycin (Drug)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Piperacillin/tazobactam (Drug)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Corticosteroid injection (Drug)
An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Oxygen Therapy Status at Day 2
时间窗: At 2 after RT
To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir \>VMK \>Nasal Cannula-(NC).)
Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2
时间窗: At 2 days after RT
To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy \>93% (Pulse oximeter measurement)
次要结局
- Blood Gas Analysis at Day 2(At 2 days after RT)
- Blood Test at Day 2(At 2 days after RT)
- Oxygen Therapy Status at Day 5(At 5 after RT)
- Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5(At 5 days after RT)
- Blood Test at Day 5(At 5 days after RT)
- Oxygen Therapy Status at Day 7(At 7 after RT)
- Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7(At 7 days after RT)
- Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1(At 1 month after RT)
- Blood Test at Day 7(At 7 days after RT)
- Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7(At 7 days after RT)
- Acute Toxicity(1-3 months after RT)
- Recovery time(From RT administration until hospital discharge or death)
- COVID-19 status(At 7 days after RT)