ORIGINAL RESEARCH article
Front. Immunol.
Sec. Viral Immunology
Convalescent Plasma Therapy for COVID-19 Prophylaxis in Adults Early Post-Hematopoietic Stem Cell Transplantation: One-Year Outcomes from a Randomized Controlled Trial
Provisionally accepted
YIGENG CAO
Qiang Li
Wenwen GuoMingyue XuKuo FangFengjiao WangRongli ZhangLin LiJialin WeiZhenyun LiuChen Liang
Weihua ZhaiQiaoling MaXin ChenWenbin Cao
Donglin Yang
Yi He
Aiming Pang
Sizhou FengMingzhe Han
Jiali Sun*
Erlie Jiang*- State Key Laboratory of Experimental Hematology, Peking Union Medical College Hospital (CAMS), Tianjin, China
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To evaluate the efficacy of COVID-19 convalescent plasma (CCP) in preventing SARS-CoV-2 infection in hematopoietic stem cell transplantation (HSCT) recipients during the early post-transplant period, a single-center, randomized controlled trial was conducted between June 2023 and February 2024. Seventy-two participants were randomized 1:1 to receive CCP (200 mL on days +14, +28, +2 months, and +3 months post-transplant) or standard treatment. The primary outcome was COVID-19 infection within 28 days after the last infusion; secondary outcomes included severe infection, adverse events, and survival. The CCP and standard treatment group each included 36 patients. In the CCP group, 26 (72.2%, 26/36) patients completed four cycles of plasma infusion and 33 (33/36, 91.7%) patients received at least one infusion. The median time to infection was 95 days (IQR 81-106) in the CCP group and 74 days (IQR 48-110) in the standard group (p = 0.272). The 120-day cumulative COVID-19 incidence was 32.1% (95% CI, 14.5-46.1%) in the CCP group and 22.9% (95% CI, 7.6-35.6%) in the standard treatment group (p=0.459). Severe cases occurred in one patient per group, with no 30-day mortality. One-year overall survival (OS) was lower in the CCP group compared to the standard treatment group (73.1% [95% CI, 59.4-90.0%] vs. 91.7% [83.1-100%], p=0.044). At 90 days post-transplantation, the peripheral blood CD4/CD8 ratio in patients of the CCP group was significantly lower than that in the standard treatment group (p = 0.008). Adverse events were observed in only 3 patients and were mild. CCP recipients had higher antibody levels, but differences were not significant. These findings indicate that CCP did not prevent COVID-19 infection and may have limited efficacy in early post-transplant patients.
Keywords: Convalescent plasma, COVID-19, Hematopoietic Stem Cell Transplantation, prophylaxis, randomized controlled trial
Received: 11 May 2025; Accepted: 11 Nov 2025.
Copyright: © 2025 CAO, Li, Guo, Xu, Fang, Wang, Zhang, Li, Wei, Liu, Liang, Zhai, Ma, Chen, Cao, Yang, He, Pang, Feng, Han, Sun and Jiang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Jiali Sun, sunjiali@ihcams.ac.cn
Erlie Jiang, doctor_eljiang@163.com
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