NCT04366791终止1 期
The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Rate of extubation (for intubated patients)
研究概览
简要总结
This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.
详细描述
PRIMARY OBJECTIVE:
I. To compare treatment of COVID-19 between best supportive care plus provider's treatment choice versus best supportive care plus low-dose, whole-lung radiation therapy
OUTLINE:
Patients undergo 1 fraction of low-dose radiation therapy.
After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a positive test confirming the diagnosis of COVID-19
- •Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment)
- •Have visible consolidations/ground glass opacities on chest x-ray or computed tomography
- •Have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy.
- •Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
- •Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
排除标准
- •No use of disallowed medications 1 day prior to delivery of LDRT: Azithromycin, chloroquine, hydrochloroquine, COVID-targeted antiviral medications
- •Pregnant and/or planned to be pregnant within in next 6 months
结局指标
主要结局
Rate of extubation (for intubated patients)
时间窗: Screening up to 28 days after radiation therapy
The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level.
次要结局
- Clinical outcome - Tidal volume(Screening up to 28 days after radiation therapy)
- Serologic outcome - LDH(Screening up to 28 days after radiation therapy)
- Clinical outcome - Intubation/Extubation events(Screening up to 28 days after radiation therapy)
- Radiographic outcome - CT can(Screening up to 28 days after radiation therapy)
- Serologic outcome - Hgb(Screening up to 28 days after radiation therapy)
- Serologic outcome - ANC(Screening up to 28 days after radiation therapy)
- Clinical outcome - Overall survival(Screening up to 28 days after radiation therapy)
- Serologic outcome - PT/PTT(Screening up to 28 days after radiation therapy)
- Serologic outcome -Triglycerides(Screening up to 28 days after radiation therapy)
- Serologic outcome - Potassium(Screening up to 28 days after radiation therapy)
- Clinical outcome - Temperature(Screening up to 28 days after radiation therapy)
- Clinical outcome - Systolic blood pressure(Screening up to 28 days after radiation therapy)
- Clinical outcome - Oxygenation(Screening up to 28 days after radiation therapy)
- Clinical outcome - Respirations(Screening up to 28 days after radiation therapy)
- Serologic outcome - Procalcitonin(Screening up to 28 days after radiation therapy)
- Clinical outcome - FiO2(Screening up to 28 days after radiation therapy)
- Serologic outcome - Creatine kinase(Screening up to 28 days after radiation therapy)
- Serologic outcome - Myoglobin(Screening up to 28 days after radiation therapy)
- Serologic outcome - Albumin(Screening up to 28 days after radiation therapy)
- Serologic outcome -Fibrinogen(Screening up to 28 days after radiation therapy)
- Serologic outcome -Bilirubin(Screening up to 28 days after radiation therapy)
- Serologic outcome - EGFR(Screening up to 28 days after radiation therapy)
- Serologic outcome - AST(Screening up to 28 days after radiation therapy)
- Serologic outcome - BNP(Screening up to 28 days after radiation therapy)
- Serologic outcome - Blood Gases pH(Screening up to 28 days after radiation therapy)
- Clinical outcome - PEEP(Screening up to 28 days after radiation therapy)
- Clinical outcome - Heart Rate(Screening up to 28 days after radiation therapy)
- Radiographic outcome - Chest xray(Screening up to 28 days after radiation therapy)
- Serologic outcome - WBC(Screening up to 28 days after radiation therapy)
- Serologic outcome - D-Dimer(Screening up to 28 days after radiation therapy)
- Serologic outcome - CRP(Screening up to 28 days after radiation therapy)
- Serologic outcome - ALT(Screening up to 28 days after radiation therapy)
- Serologic outcome - GGT(Screening up to 28 days after radiation therapy)
- Serologic outcome -Ferritin(Screening up to 28 days after radiation therapy)
- Serologic Immune markers flow cytometry(Screening up to 28 days after radiation therapy)
- Serologic outcome - Creatinine(Screening up to 28 days after radiation therapy)
- Serologic outcome - Troponin-I(Screening up to 28 days after radiation therapy)
- Serologic outcome - Lactic Acid(Screening up to 28 days after radiation therapy)
- Serologic outcome - IL-6(Screening up to 28 days after radiation therapy)
- Serologic outcome - Blood Gases pO2(Screening up to 28 days after radiation therapy)
- Serologic outcome - Blood Gases pCO2(Screening up to 28 days after radiation therapy)
研究者
Mohammad K. Khan
Study Principal Investigator
Emory University
研究点 (4)
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