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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

Sponsor
Institute of Hematology & Blood Diseases Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05904067
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
18.8
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID Convalescent Plasma
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Institute of Hematology & Blood Diseases Hospital
Anticipated Study Start Date :
Jun 10, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the prevalence of new COVID infection [1 year]

      within +28 days after the last infusion of CCP

    Secondary Outcome Measures

    1. To evaluate the incidence of severe COVID-19 [1 year]

      within +28 days after the last infusion of CCP

    2. To evaluate the survival rate of COVID-19 infection [1 year]

      within 30 days after COVID-19 infection within +28 days after last CCP infusion

    3. To evaluate the overall survival [1 year]

      at 1 year after transplantation.

    4. To evaluate the tolerance of CCP infusion [1 year]

      at 1 year after transplantation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin None Selected China 300020

    Sponsors and Collaborators

    • Institute of Hematology & Blood Diseases Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of Hematology & Blood Diseases Hospital
    ClinicalTrials.gov Identifier:
    NCT05904067
    Other Study ID Numbers:
    • CCP-COVID-19-HSCT-2023
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institute of Hematology & Blood Diseases Hospital
    COVID-19 Convalescent Plasma
    Hematopoietic Stem Cell Transplantation
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 15, 2023