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

June 13, 2023 updated by: Institute of Hematology & Blood Diseases Hospital

Institute of Hematology & Blood Diseases Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • None Selected
      • Tianjin, None Selected, China, 300020
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recipient of 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.
Biological: COVID Convalescent Plasma
200 ml of COVID Convalescent Plasma at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation.
Other Names:
  • CCP, COVID-19 Convalescent Plasma
No Intervention: Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion
Control group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the prevalence of new COVID infection
Time Frame: 1 year
within +28 days after the last infusion of CCP
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCP-COVID-19-HSCT-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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