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索托维单抗在儿童中的早期应用:一名感染新冠病毒的11岁肾移植受者的病例报告

Early Use of Sotrovimab in Children: A Case Report of an 11-Year-Old Kidney Transplant Recipient Infected with SARS-CoV-2.

作者信息

Di Chiara Costanza, Mengato Daniele, De Pieri Marica, Longo Germana, Benetti Elisa, Venturini Francesca, Giaquinto Carlo, Donà Daniele

机构信息

Department for Women's and Children's Health, Division of Pediatric Infectious Diseases, University of Padua, 35128 Padua, Italy.

Hospital Pharmacy Department, University Hospital of Padova, 35121 Padua, Italy.

出版信息

Children (Basel). 2022 Mar 23;9(4):451. doi: 10.3390/children9040451.

DOI:10.3390/children9040451
PMID:35455495
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9028505/
Abstract

BACKGROUND

The use of virus-neutralizing monoclonal antibodies has been approved in fragile populations, including kidney transplant recipients, who are at risk of developing severe COVID-19. Sotrovimab is the only currently available anti-SARS-CoV-2 neutralizing monoclonal antibody with activity against the new Omicron variant of concern. While sotrovimab has been approved in adolescents and adults, studies regarding its efficacy and safety in children aged less than 12 years old and weighing less than 40 kg are still lacking. Here, we report a first case of a child, who was treated early with sotrovimab after a kidney transplant.

CASE REPORT

At the end of January 2022, a 11-year-old male child underwent a deceased-donor kidney transplant and became infected with SARS-CoV-2 during the first day after surgery. Due to the increased risk of developing severe COVID-19, based on the predominance of Omicron and the patient's renal function, the child was treated with sotrovimab. The clinical course was successful and no adverse reactions were reported.

CONCLUSIONS

For the first time, we report the well-tolerated use of sotrovimab in children under 12 years old. As the pandemic affects children across the globe, urgent data on sotrovimab dosing in children with a higher risk of developing severe COVID-19 are needed.

摘要

背景

病毒中和单克隆抗体已被批准用于包括肾移植受者在内的脆弱人群,这些人群有发展为重症 COVID-19 的风险。索托维单抗是目前唯一可用的抗 SARS-CoV-2 中和单克隆抗体,对新出现的值得关注的奥密克戎变异株具有活性。虽然索托维单抗已在青少年和成人中获得批准,但关于其在 12 岁以下、体重小于 40 公斤儿童中的疗效和安全性的研究仍然缺乏。在此,我们报告首例肾移植后早期接受索托维单抗治疗的儿童病例。

病例报告

2022 年 1 月底,一名 11 岁男童接受了死体供肾移植,术后第一天感染了 SARS-CoV-2。由于发展为重症 COVID-19 的风险增加,基于奥密克戎毒株的优势以及患者的肾功能,该儿童接受了索托维单抗治疗。临床过程顺利,未报告不良反应。

结论

我们首次报告了索托维单抗在 12 岁以下儿童中耐受性良好的使用情况。由于全球大流行影响儿童,迫切需要有关索托维单抗在发展为重症 COVID-19 风险较高儿童中的给药数据。

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Eligibility criteria for pediatric patients who may benefit from anti SARS-CoV-2 monoclonal antibody therapy administration: an Italian inter-society consensus statement.儿科患者使用抗 SARS-CoV-2 单克隆抗体治疗的资格标准:意大利多学会共识声明。
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