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Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Rachel Gross1, Tanayott Thaweethai2, Erika B Rosenzweig3
1Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.
Insights
The RECOVER-Pediatrics study protocol outlines a large-scale investigation into Long COVID (post-acute sequelae of SARS-CoV-2) in youth. This research aims to define PASC, its mechanisms, and potential treatments in children and young adults.
Area of Science:
- Pediatric Health
- Infectious Diseases
- Epidemiology
Background:
- The long-term effects and mechanisms of post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID, in children and young adults are not well understood.
- There is an urgent need to define PASC in pediatric populations to identify mechanisms and potential therapeutic targets.
Conclusions:
- The RECOVER-Pediatrics protocol provides a framework for a comprehensive investigation into the impact of PASC on children and young adults.
- Findings from this study are expected to significantly advance the understanding of pediatric PASC, informing clinical care and therapeutic strategies.
- The adaptive and collaborative nature of the protocol ensures its relevance and responsiveness to emerging scientific knowledge.
Importance:
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.
Observations:
We describe the protocol for the Pediatric Observational Cohort Study of the NIH's RE searching COV ID to E nhance R ecovery (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 five 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.
Conclusions And Relevance:
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 Trialsgov Identifier:
Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.
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