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RECAST:一项观察性研究的研究方案,旨在了解儿童在 SARS-CoV-2 感染中比成人具有更高的恢复力。

RECAST: Study protocol for an observational study for the understanding of the increased REsilience of Children compared to Adults in SARS-CoV-2 infecTion.

机构信息

Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.

Karsten, Rugo, Wagner, Paediatric Practice, Berlin, Germany.

出版信息

BMJ Open. 2023 Apr 17;13(4):e065221. doi: 10.1136/bmjopen-2022-065221.

Abstract

INTRODUCTION

The SARS-CoV-2 pandemic remains a threat to public health. Soon after its outbreak, it became apparent that children are less severely affected. Indeed, opposing clinical manifestations between children and adults are observed for other infections. The SARS-CoV-2 outbreak provides the unique opportunity to study the underlying mechanisms. This protocol describes the methods of an observational study that aims to characterise age dependent differences in immune responses to primary respiratory infections using SARS-CoV-2 as a model virus and to assess age differences in clinical outcomes including lung function.

METHODS AND ANALYSIS

The study aims to recruit at least 120 children and 60 adults that are infected with SARS-CoV-2 and collect specimen for a multiomics analysis, including single cell RNA sequencing of nasal epithelial cells and peripheral blood mononuclear cells, mass cytometry of whole blood samples and nasal cells, mass spectrometry-based serum and plasma proteomics, nasal epithelial cultures with functional in vitro analyses, SARS-CoV-2 antibody testing, sequencing of the viral genome and lung function testing. Data obtained from this multiomics approach are correlated with medical history and clinical data. Recruitment started in October 2020 and is ongoing.

ETHICS AND DISSEMINATION

The study was reviewed and approved by the Ethics Committee of Charité - Universitätsmedizin Berlin (EA2/066/20). All collected specimens are stored in the central biobank of Charité - Universitätsmedizin Berlin and are made available to all participating researchers and on request.

TRIAL REGISTRATION NUMBER

DRKS00025715, pre-results publication.

摘要

简介

SARS-CoV-2 大流行仍然是对公众健康的威胁。在疫情爆发后不久,人们就明显发现儿童受影响的程度较轻。实际上,其他感染也存在儿童和成人临床表现不同的情况。SARS-CoV-2 疫情的爆发为研究潜在机制提供了独特的机会。本方案描述了一项观察性研究的方法,该研究旨在使用 SARS-CoV-2 作为模型病毒,描述儿童和成人免疫反应的年龄依赖性差异,评估包括肺功能在内的临床结局的年龄差异。

方法和分析

该研究计划招募至少 120 名儿童和 60 名感染 SARS-CoV-2 的成年人,并收集样本进行多组学分析,包括鼻上皮细胞和外周血单核细胞的单细胞 RNA 测序、全血样本和鼻细胞的质谱流式细胞术、基于质谱的血清和血浆蛋白质组学、具有体外功能分析的鼻上皮培养、SARS-CoV-2 抗体检测、病毒基因组测序和肺功能检测。从这种多组学方法获得的数据与病史和临床数据相关联。招募工作于 2020 年 10 月开始,正在进行中。

伦理和传播

该研究已由柏林夏洛蒂医科大学伦理委员会(EA2/066/20)审查和批准。所有收集的标本都储存在柏林夏洛蒂医科大学的中央生物库中,并提供给所有参与研究人员,并应要求提供。

试验注册号

DRKS00025715,预发表结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c548/10111194/a90ba044539a/bmjopen-2022-065221f01.jpg

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