A Study 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
- Conditions
- COVID-19Hematopoietic Stem Cell Transplantation
- Interventions
- Biological: COVID Convalescent Plasma
- Registration Number
- NCT05904067
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion COVID Convalescent Plasma Transfusion of COVID-19 convalescent plasma to participants The experimental group (CCP group): 200 ml of CCP at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation.
- Primary Outcome Measures
Name Time Method To evaluate the prevalence of new COVID infection 1 year within +28 days after the last infusion of CCP
- Secondary Outcome Measures
Name Time Method To evaluate the survival rate of COVID-19 infection 1 year within 30 days after COVID-19 infection within +28 days after last CCP infusion
To evaluate the tolerance of CCP infusion 1 year at 1 year after transplantation.
To evaluate the overall survival 1 year at 1 year after transplantation.
To evaluate the incidence of severe COVID-19 1 year within +28 days after the last infusion of CCP
Trial Locations
- Locations (1)
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
🇨🇳Tianjin, None Selected, China