儿童新冠病毒长期结局研究（PECOS）：基线横断面分析
Pediatric SARS-CoV-2 long term outcomes study (PECOS): cross sectional analysis at baseline.
作者信息
Montealegre Sanchez Gina A, Arrigoni Lauren E, Yonts Alexandra B, Rubenstein Kevin B, Bost James E, Wolff Max T, Barrix Mallory C, Bandettini W Patricia, Boateng Bema, Bulas Dorothy I, Burklow Thomas R, Carlyle Kayla P, Chen Marcus, Das Sanchita, Dewar Robin L, Dixon Austin A, Edu Maureen A, Falik Rachel L, Geslak Monika L, Gierdalski Marcin, Harahsheh Ashraf S, Herbert Linda J, Highbarger Jeroen, Huq Saira R, Ko Arthur, Koumbourlis Anastassios C, Lacey Stephanie R, Lipton Andrew J, Monaghan Maureen, Ndour Anta S, Olivieri Laura J, Pillai Dinesh K, Rehm Catherine A, Sable Craig A, Sachdev Vandana, Thurm Audrey E, Truong Uyen T, Turkbey Evrim B, Vilain Eric, Weyers Shera, White Jacob S, Williams Abigail A, Zember Jonathan, Liang C Jason, Delaney Meghan, Batshaw Mark L, Notarangelo Luigi D, Wessel David L, Barron Karyl, DeBiasi Roberta L
机构信息
Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.
Center for Cancer and Immunology Research (CCIR), Children's National Research Institute, Washington, DC, USA.
出版信息
Pediatr Res. 2024 Dec 18. doi: 10.1038/s41390-024-03777-1.
BACKGROUND
PECOS is an ongoing study aimed to characterize long-term outcomes following pediatric SARS-CoV-2 infection.
METHODS
This is a cross-sectional analysis of infected and uninfected cohorts at baseline. Participants (0-21 years) with laboratory-confirmed SARS-CoV-2 infection were enrolled as infected. Uninfected were defined as individuals without history or laboratory evidence of SARS-CoV-2 infection. Outcome measures included demographics, medical history, review of symptoms, physical exam, cardiopulmonary evaluation and validated psychological and developmental surveys. Primary outcomes were cohort comparisons for abnormalities on all measures.
RESULTS
654 participants (541 infected, 113 uninfected) completed baseline visits by June 30, 2023. Infected participants were more likely to report constitutional (OR: 2.24), HEENT (OR: 3.74); respiratory (OR: 2.41), or gastrointestinal (OR: 2.58) symptoms. Infected had worse scores in domains of Pain, Fatigue, Global Health, Physical and Cognitive functioning, Mobility and Sleep disturbances when compared to uninfected controls using Patient Reported Outcomes. Cardiopulmonary findings were similar among cohorts.
CONCLUSIONS
The first report of this ongoing longitudinal study demonstrates that infected participants were more likely to report symptoms compared to uninfected controls, which may affect performance and quality of life of these individuals. Longitudinal data will increase understanding of long-term effects of SARS-CoV-2 infection in children.
CLINICALTRIALS
gov Identifier: NCT04830852 IMPACT: This study establishes a large, diverse, prospective, longitudinal, multi-center cohort of children with history of SARS-CoV-2 infection compared to an uninfected cohort to be followed for 3 years. Cross-sectional cohort analysis at study entry showed infected participants were more likely to report constitutional, respiratory, and GI symptoms compared to uninfected controls. Infected participants were more likely to have significantly worse parent-reported performance in 6 of 10 Patient Reported Outcome Measures domains. Continued study of this cohort will help identify clinical sequelae of COVID-19, characterize the immune response to SARS-CoV-2 infection, and identify potential genetic/immunologic factors associated with long-term outcomes.
背景
PECOS是一项正在进行的研究，旨在描述儿童感染SARS-CoV-2后的长期结局。
方法
这是一项对基线时感染和未感染队列的横断面分析。将实验室确诊感染SARS-CoV-2的参与者（0至21岁）纳入感染组。未感染组定义为无SARS-CoV-2感染病史或实验室证据的个体。结局指标包括人口统计学、病史、症状回顾、体格检查、心肺评估以及经过验证的心理和发育调查。主要结局是所有指标异常情况的队列比较。
结果
截至2023年6月30日，654名参与者（541名感染，113名未感染）完成了基线访视。感染的参与者更有可能报告全身性（比值比：2.24）、头、眼、耳、鼻、喉（比值比：3.74）、呼吸（比值比：2.41）或胃肠道（比值比：2.58）症状。与未感染的对照组相比，使用患者报告结局时，感染组在疼痛、疲劳、整体健康、身体和认知功能、活动能力以及睡眠障碍等领域的得分更低。各队列的心肺检查结果相似。
结论
这项正在进行的纵向研究的首次报告表明，与未感染的对照组相比，感染的参与者更有可能报告症状，这可能会影响这些个体的表现和生活质量。纵向数据将增进对儿童SARS-CoV-2感染长期影响的了解。
临床试验
美国国立医学图书馆标识符：NCT04830852 影响：本研究建立了一个大型、多样化、前瞻性、纵向、多中心的有SARS-CoV-2感染病史儿童队列，并与一个未感染队列进行比较，随访3年。研究开始时的横断面队列分析显示，与未感染的对照组相比，感染的参与者更有可能报告全身性、呼吸和胃肠道症状。在10项患者报告结局指标中的6项中，感染的参与者更有可能出现家长报告的明显更差的表现。对该队列的持续研究将有助于确定COVID-19的临床后遗症，描述对SARS-CoV-2感染的免疫反应，并确定与长期结局相关的潜在遗传/免疫因素。
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