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
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Jun 2023
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2023
CompletedFirst Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJune 15, 2023
June 1, 2023
7 months
June 13, 2023
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the prevalence of new COVID infection
within +28 days after the last infusion of CCP
1 year
Secondary Outcomes (4)
To evaluate the incidence of severe COVID-19
1 year
To evaluate the survival rate of COVID-19 infection
1 year
To evaluate the overall survival
1 year
To evaluate the tolerance of CCP infusion
1 year
Study Arms (2)
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
EXPERIMENTALTransfusion 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.
Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion
NO INTERVENTIONControl group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation.
Interventions
200 ml of COVID Convalescent Plasma at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, None Selected, 300020, China
Related Publications (1)
Cao Y, Li Q, Guo W, Xu M, Fang K, Wang F, Zhang R, Li L, Wei J, Liu Z, Liang C, Zhai W, Ma Q, Chen X, Cao W, Yang D, He Y, Pang A, Feng S, Han M, Sun J, Jiang E. Convalescent plasma therapy for COVID-19 prophylaxis in adults early post-hematopoietic stem cell transplantation: one-year outcomes from a randomized controlled trial. Front Immunol. 2025 Nov 28;16:1626775. doi: 10.3389/fimmu.2025.1626775. eCollection 2025.
PMID: 41394817DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
June 15, 2023
Study Start
June 10, 2023
Primary Completion
January 1, 2024
Study Completion
January 1, 2025
Last Updated
June 15, 2023
Record last verified: 2023-06