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临床试验/NCT04493294
NCT04493294Unknown1 期

Low Dose Whole Lung Radiotherapy for Older Patients With Coronavirus 19 Disease (COVID-19) Pneumonitis: Practical Protocol by the International Geriatric Radiotherapy Group

International Geriatric Radiotherapy Group0 个研究点目标入组 500 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
500
主要终点
Mortality rate

研究概览

简要总结

Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis

详细描述

Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic inflammation of older patients and minorities may make them more vulnerable to the cytokines storm generated by the viral infection in addition to preexisting co-morbidity.

Even though multiple organs failure result from the cytokine storm, pneumonia and respiratory failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the inflammatory response and may decrease the need for artificial ventilation, thus improving mortality rate.

Methods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from 26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of COVID-19 patients. The patients who will be selected would have developed pneumonias but did not require artificial ventilation. These patients will be followed for a year after receiving this treatment. Their physical activities will be monitored through the ordinal scale and will be correlated with their cytokines status and oxygen saturation rate to assess the impact of the residual inflammation on their daily life. Mortality rates between different ethnic group will be compared and correlated with their cytokines response to the virus and number of co-morbidities.

Discussion and importance of the study: We postulate that LDWLRT may improve survival rates of all patients by preventing the need for artificial ventilation which is associated with a high mortality. The inflammatory response between different ethnic groups before and following radiotherapy will be valuable to serve as baseline for future prospective pandemic studies as it has not been reported before.

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

入选标准

  • 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen

排除标准

  • Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial

结局指标

主要结局

Mortality rate

时间窗: One year

Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data

次要结局

  • Time to recovery(One month)
  • Oxygen saturation rate(One year)
  • Mortality rate(One year)
  • Duration of hospitalization(One year)
  • Patient inflammatory status(One year)

研究者

发起方
International Geriatric Radiotherapy Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nam Nguyen

President

International Geriatric Radiotherapy Group

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