drugset / Trial / 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

NCT05904067 ↗

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2023-06-10
Primary completion
2024-01-01
Completion
2025-01-01

Outcome

Missed primary endpoint

paper These findings indicate that CCP did not prevent COVID-19 infection PMID 41394817 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject COVID Convalescent Plasma Protein / enzyme biologic 200 ml Other