Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, United States of America.
Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
PLoS One. 2024 May 7;19(5):e0285635. doi: 10.1371/journal.pone.0285635. eCollection 2024.
The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults.
We describe the protocol for the Pediatric Observational Cohort Study of the NIH's REsearching COVID to Enhance Recovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of four cohorts that comprise RECOVER-Pediatrics: 1) a de novo RECOVER prospective cohort of children and young adults with and without previous or current infection; and 2) an extant cohort derived from the Adolescent Brain Cognitive Development (ABCD) study (n = 10,000). The de novo cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n = 6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n = 6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n = 600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science.
RECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions.
CLINICAL TRIALS.GOV IDENTIFIER: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.
儿童和青少年中 COVID-19（SARS-CoV-2 后遗留的后遗症[PASC]或“长新冠”）的流行率、病理生理学和长期结果尚不清楚。研究必须解决定义儿童和青少年 PASC、其机制以及潜在治疗靶点的迫切需要。
我们描述了 NIH 的研究 COVID 以增强康复（RECOVER）计划的儿科观察队列研究的方案。RECOVER-Pediatrics 是一项针对护理人员-儿童对（出生至 17 岁）和年轻人（18 至 25 岁）的观察性元队列研究，在美国 100 多个地点招募。本报告重点介绍了构成 RECOVER-Pediatrics 的四个队列中的两个：1）一个新的、前瞻性的患有和不患有既往或当前感染的儿童和年轻人队列；和 2）源自青少年大脑认知发展（ABCD）研究的现有队列（n=10000）。新队列纳入了三层数据收集：1）远程基线评估（第 1 层，n=6000）；2）最长 4 年的纵向随访（第 2 层，n=6000）；和 3）一部分参与者，主要是受 PASC 影响最严重的参与者，将进行深度表型分析以探索 PASC 的病理生理学（第 3 层，n=600）。参加 ABCD 研究的年轻人参加第 1 层。儿科方案是由研究人员、患者、研究人员、临床医生、社区合作伙伴和联邦合作伙伴共同制定的合作伙伴关系，旨在促进包容性和多样性。该方案具有适应性，可促进对新兴科学的回应。
RECOVER-Pediatrics 旨在从出生到 25 岁描述 PASC 的临床过程、潜在机制和长期影响。RECOVER-Pediatrics 旨在阐明儿科 PASC 的流行病学、四年临床过程和社会人口统计学相关性。这些数据和生物样本将允许检查机制假说和生物标志物，从而为潜在的治疗干预提供见解。
临床试验.gov 标识符：临床试验注册：http://www.clinicaltrials.gov。唯一标识符：NCT05172011。
