Clinical trial NCT05904067: 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
Official title: Institute of Hematology & Blood Diseases Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Hematopoietic Stem Cell Transplantation
Keywords: COVID-19 Convalescent Plasma
Hematopoietic Stem Cell Transplantation
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the prevalence of new COVID infection
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the incidence of severe COVID-19
timeFrame: 1 year
measure: To evaluate the survival rate of COVID-19 infection
timeFrame: 1 year
measure: To evaluate the overall survival
timeFrame: 1 year
measure: To evaluate the tolerance of CCP infusion
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
state: None Selected
Study officials:
References: