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
COVID-19, Hematopoietic Stem Cell Transplantation
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19 Convalescent Plasma, Hematopoietic Stem Cell Transplantation
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion
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.
Control group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation.