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 celltransplantation.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, +28days, +2 months, and +3 months following hematopoietic stem cell transplantation.Patients in the control group would be routinely given oral ursodeoxycholic acid for +14days after transplantation.The primary goal of the study is to evaluate the safety of CCP and the incidence ofCOVID-19 infection within +28 days after the last infusion of CCP.
Not Provided
Biological: COVID Convalescent Plasma
200 ml of COVID Convalescent Plasma at +14 days, +28 days, +2 months, and +3 months
following hematopoietic stem cells transplantation.
Other Name: CCP, COVID-19 Convalescent Plasma
Inclusion Criteria:
1. receive hematopoietic stem cell transplantation
2. Be ≥ 16 years of age on the day of enrollment.
3. Understand the study procedures, alternative treatment available, and risks involved
with the study, and voluntarily agree to participate by giving written informed
consent.
Exclusion Criteria:
1. Positive serological response to known HIV or active hepatitis C virus.
2. Patients with mental illness or other conditions that do not meet the requirements
of research treatment and monitoring.
3. Unable or unwilling to sign consent form.
4. Patients with other special conditions assessed as unqualified by the researchers.
5. Patients suffered COVID-19 infection between day 0 and infusion of CCP after
transplantation.
Drop-out and Withdrawal Criteria
1. Failure of engraftment within 30 days of transplantation;
2. Patients who are not compliant with the requirements of the study and fail to follow
the study plan.
3. Patients receiving prophylaxis for COVID-19 infection by methods other than this
protocol during the trial.
4. 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.
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, None Selected, China
Investigator: Erlie C Plasma
Contact: 223909274
doctor_eljiang@163.com
Not Provided