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

Institute of Hematology & Blood Diseases Hospital, China

Status: Enrolling

Conditions: COVID-19; Hematopoietic Stem Cell Transplantation

Treatments: Biological: COVID Convalescent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05904067

CCP-COVID-19-HSCT-2023

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Experimental group

Description:

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.

Treatment:

Biological: COVID Convalescent Plasma

Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion

No Intervention group

Description:

Control group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation.