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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion | Experimental | 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. |
|
| Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion | No Intervention | Control group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID Convalescent Plasma | Biological | 200 ml of COVID Convalescent Plasma at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the prevalence of new COVID infection | within +28 days after the last infusion of CCP | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the incidence of severe COVID-19 | within +28 days after the last infusion of CCP | 1 year |
| To evaluate the survival rate of COVID-19 infection | within 30 days after COVID-19 infection within +28 days after last CCP infusion |
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Inclusion Criteria:
Exclusion Criteria:
Drop-out and Withdrawal Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | None Selected | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41394817 | Derived | Cao Y, Li Q, Guo W, Xu M, Fang K, Wang F, Zhang R, Li L, Wei J, Liu Z, Liang C, Zhai W, Ma Q, Chen X, Cao W, Yang D, He Y, Pang A, Feng S, Han M, Sun J, Jiang E. Convalescent plasma therapy for COVID-19 prophylaxis in adults early post-hematopoietic stem cell transplantation: one-year outcomes from a randomized controlled trial. Front Immunol. 2025 Nov 28;16:1626775. doi: 10.3389/fimmu.2025.1626775. eCollection 2025. |
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|
| 1 year |
| To evaluate the overall survival | at 1 year after transplantation. | 1 year |
| To evaluate the tolerance of CCP infusion | at 1 year after transplantation. | 1 year |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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