Institute of Hematology & Blood Diseases Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate the prevalence of new COVID infection
研究概览
简要总结
The study is to evaluate the safety and efficacy of COVID-19 convalescent plasma (CCP) transfusion to prevent COVID-19 in adult recipients following hematopoietic stem cell transplantation.
72 patients will be randomized in a 1:1 ratio to receive either CCR (36 patients) or not (36 patients). Patients in the CCP group will receive 200 ml of CCP at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cell transplantation. Patients in the control group would be routinely given oral ursodeoxycholic acid for +14 days after transplantation.
The primary goal of the study is to evaluate the safety of CCP and the incidence of COVID-19 infection within +28 days after the last infusion of CCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receive hematopoietic stem cell transplantation
- •Be ≥ 16 years of age on the day of enrollment.
- •Understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
排除标准
- •Positive serological response to known HIV or active hepatitis C virus.
- •Patients with mental illness or other conditions that do not meet the requirements of research treatment and monitoring.
- •Unable or unwilling to sign consent form.
- •Patients with other special conditions assessed as unqualified by the researchers.
- •Patients suffered COVID-19 infection between day 0 and infusion of CCP after transplantation.
- •Drop-out and Withdrawal Criteria
- •Failure of engraftment within 30 days of transplantation;
- •Patients who are not compliant with the requirements of the study and fail to follow the study plan.
- •Patients receiving prophylaxis for COVID-19 infection by methods other than this protocol during the trial.
- •A patient may withdraw from the study if he/she does not wish to continue participating in the study, and the date and reason for withdrawal shall be recorded. The investigator may also decide to discontinue a patient from the clinical study if there is an unacceptable risk.
结局指标
主要结局
To evaluate the prevalence of new COVID infection
时间窗: 1 year
within +28 days after the last infusion of CCP
次要结局
- To evaluate the survival rate of COVID-19 infection(1 year)
- To evaluate the tolerance of CCP infusion(1 year)
- To evaluate the overall survival(1 year)
- To evaluate the incidence of severe COVID-19(1 year)