NCT05694962尚未招募2 期
Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study
Jiangsu Cancer Institute & Hospital0 个研究点目标入组 40 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Clinical improvement
研究概览
简要总结
This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.
详细描述
PRIMARY OBJECTIVE:
I. To compare treatment of severe COVID-19 pneumonia between supportive care and standard of care drug therapies versus supportive care and standard of care drug therapies plus low-dose, whole-lung radiation therapy
OUTLINE:
Patients undergo 1.5Gy of single 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（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 been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy;
- •They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form.
排除标准
- •Have received chest radiotherapy before
- •Bacteria, fungi and other infections other than novel coronavirus infection;
- •Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function ALT and AST> normal reference value, the upper limit of Scr> normal reference value, poor blood glucose control);
- •Mental retardation, mental disorders;
- •Planned pregnancy, pregnancy, lactation women and during the trial;
- •Allergy constitution or allergy to the drug ingredients and excipients of this test;
- •Participated in other clinical trials in the recent 1 month;
- •The Investigator does not considered appropriate to participate in this clinical trial.
结局指标
主要结局
Clinical improvement
时间窗: 28 days after radiation therapy
improvement of oxygen saturation in percentage
次要结局
- Temperature(28 days after radiation therapy)
- Systolic blood pressure(28 days after radiation therapy)
- PEEP Tidal volume Tidal volume(28 days after radiation therapy)
- Overall survival Overall survival(28 days after radiation therapy)
- Chest CT can(28 days after radiation therapy)
- FiO2(28 days after radiation therapy)
- Heart Rate(28 days after radiation therapy)
- Blood Test(28 days after radiation therapy)
- Urine Test(28 days after radiation therapy)
- Respirations Respirations Respirations Respirations Respirations Respirations(28 days after radiation therapy)
研究者
Dr. He Xia
Vice President
Jiangsu Cancer Institute & Hospital
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