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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

Primary Purpose

COVID-19, Hematopoietic Stem Cell Transplantation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
COVID Convalescent Plasma
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion

Arm 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.

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

Outcomes

Primary Outcome Measures

To evaluate the prevalence of new COVID infection
within +28 days after the last infusion of CCP

Secondary Outcome Measures

To evaluate the incidence of severe COVID-19
within +28 days after the last infusion of CCP
To evaluate the survival rate of COVID-19 infection
within 30 days after COVID-19 infection within +28 days after last CCP infusion
To evaluate the overall survival
at 1 year after transplantation.
To evaluate the tolerance of CCP infusion
at 1 year after transplantation.

Full Information

First Posted
June 13, 2023
Last Updated
June 13, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05904067
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Hematopoietic Stem Cell Transplantation
Keywords
COVID-19 Convalescent Plasma, Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Arm Type
Experimental
Arm 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.
Arm Title
Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion
Arm Type
No Intervention
Arm Description
Control group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation.
Intervention Type
Biological
Intervention Name(s)
COVID Convalescent Plasma
Other Intervention Name(s)
CCP, COVID-19 Convalescent Plasma
Intervention Description
200 ml of COVID Convalescent Plasma at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation.
Primary Outcome Measure Information:
Title
To evaluate the prevalence of new COVID infection
Description
within +28 days after the last infusion of CCP
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the incidence of severe COVID-19
Description
within +28 days after the last infusion of CCP
Time Frame
1 year
Title
To evaluate the survival rate of COVID-19 infection
Description
within 30 days after COVID-19 infection within +28 days after last CCP infusion
Time Frame
1 year
Title
To evaluate the overall survival
Description
at 1 year after transplantation.
Time Frame
1 year
Title
To evaluate the tolerance of CCP infusion
Description
at 1 year after transplantation.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
None Selected
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erlie C Plasma
Phone
223909274
Email
doctor_eljiang@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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