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

COVID-19 Clinical Trial

Official title:

Institute of Hematology & Blood Diseases Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904067
• Other study ID #: CCP-COVID-19-HSCT-2023
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2023
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Hematopoietic Stem Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the prevalence of new COVID infection	within +28 days after the last infusion of CCP	1 year
Secondary	To evaluate the incidence of severe COVID-19	within +28 days after the last infusion of CCP	1 year
Secondary	To evaluate the survival rate of COVID-19 infection	within 30 days after COVID-19 infection within +28 days after last CCP infusion	1 year
Secondary	To evaluate the overall survival	at 1 year after transplantation.	1 year
Secondary	To evaluate the tolerance of CCP infusion	at 1 year after transplantation.	1 year