Randomized Trial, Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical improvement
研究概览
简要总结
There are several clinical studies that mention the benefits of treatment with low-dose radiation therapy to patients with COVID 19, so this study protocol will be started to determine if there is clinical improvement with treatment and low-dose radiation therapy. to all the lung.
详细描述
Until now, multiple studies with antibiotics and monoclonal antibodies have been used to try to stop this infection, however, the studies have not been conclusive about the real benefit of these drugs, so the search for other alternatives has been an obligation for doctors in all the world. For this reason, it was proposed to carry out a treatment with radiotherapy to the lung based on studies published in the middle of the last century.
In the studies where radiation therapy was given to the lung in cases of infections in the 1930s and 1940s, the most important and with the largest number of patients are the studies by Powel, Scott, Rosseasuy and Openheimer, where together they were treated 594 patients with viral and bacterial infections, obtaining a cure in a total of 524 patients, that is, an 88% chance of cure with this treatment in an average of 7 days.
Treatment with low doses of total lung radiotherapy has not only been used in the treatment of pneumonia in 1930-1940, it has also been used recently in other pathologies such as metaplasia with myeloid myelofibrosis, where they are treated with 1 Gy to both lungs and there is a significant improvement in hypoxia, as well as edema within the first 72 hrs. without presenting side effects due to the treatment at low doses of radiotherapy, control studies were also carried out where it was shown that the low dose of Lung radiotherapy is safe and effective, these studies show that low doses of radiotherapy are safe for patients since it does not generate serious side effects that put the patient's health at risk.
These results are similar to the results obtained in one of the few studies of low-dose total lung radiotherapy in patients with COVID-19, which was performed at Emory University Hospital in Atlanta, where 5 patients with pneumonia, positive for COVID 19 that required supplemental oxygen to which they were given a treatment with radiotherapy 1.5 Gy single dose, at 24 hrs., 4 of the patients rapidly improved clinically, recovering in an average of 1.5 days (range 3 to 96 hrs.). Subsequent imaging and laboratory studies confirmed that low doses of radiation therapy are effective and safe in reducing the symptoms produced by COVID 19.
Recently at the University of Teran in Israel the results of their study were also published, which recruited 5 patients with COVID 19 pneumonia who were oxygen dependent. In this study, a single dose of 0.5 Gy was given, reporting an improvement in 80% of patients and they were discharged from 3 to 7 days.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Laboratory confirmation of SARS-CoV-2 infection
- •Acute Respiratory Distress Syndrome in any degree with a hospital treatment requirement.
排除标准
- •Patients who do not agree to receive the treatment
- •Sepsis data
- •Hemodynamic instability
结局指标
主要结局
Clinical improvement
时间窗: 7 days
improvement of oxygen saturation
次要结局
- improvement of laboratory and imaging parameters(7 -14 days)
研究者
Alejandro Olmos Guzmán
Principal Investigator, MD,
Instituto Mexicano del Seguro Social
