Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change from baseline blood oxygenation
研究概览
简要总结
Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.
详细描述
SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.
Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.
In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.
A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)
- •Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
- •Less than 3 days since the onset of ARDS
- •Age > 60 years
- •↑ IL-6 ( if available)
排除标准
- •Lack of informed consent
- •Inability to transfer to the radiation unit
- •Hemodynamic instability
- •Septic shock and organ dysfunction
- •Severe ARDS P/F ratio ≤ 100 mmHg
- •History of cardiac failure
- •Contraindications to radiation
结局指标
主要结局
Change from baseline blood oxygenation
时间窗: 28 days
O2 saturation
Number of Hospital stay days
时间窗: 28 days
Total days the patient is admitted to hospital
Number of ICU stay days
时间窗: 28 days
Total days the patient is admitted to ICU
Number of intubation events
时间窗: 28 days
Total number of intubations performed after the treatment
次要结局
- IL-6(Day 5)
- WBC(28 days)
- Platelets(28 days)
- CRP(Day 5)