NCT05904067

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-10
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: China