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Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Rachel S Gross1, Tanayott Thaweethai2, Erika B Rosenzweig3
1Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, United States of America.
Insights
The RECOVER-Pediatrics study will define post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID, in youth. This research aims to understand PASC
Area of Science:
- Pediatric Health
- Infectious Diseases
- Longitudinal Cohort Studies
Background:
- The prevalence, pathophysiology, and long-term outcomes of post-acute sequelae of SARS-CoV-2 (PASC), also known as Long COVID, in children and young adults are not well understood.
- There is an urgent need to define PASC, its underlying mechanisms, and potential therapeutic targets in pediatric and young adult populations.
Purpose of the Study:
- To characterize the clinical course, underlying mechanisms, and long-term effects of PASC in individuals from birth through 25 years old.
- To elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC.
- To examine mechanistic hypotheses and biomarkers for potential therapeutic interventions.
Main Methods:
- The RECOVER-Pediatrics study is an observational meta-cohort study involving caregiver-child pairs and young adults across over 100 US sites.
- It includes a de novo prospective cohort with three tiers of data collection: remote baseline assessments, longitudinal follow-up for up to 4 years, and deep phenotyping for severe PASC cases.
- An extant cohort from the Adolescent Brain Cognitive Development (ABCD) study is also incorporated, with a focus on inclusivity and diversity in protocol development.
Main Results:
- This report outlines the RECOVER-Pediatrics protocol, a comprehensive plan to study PASC in youth.
- The study is designed to collect extensive data and biosamples for in-depth analysis.
- The adaptive protocol allows for flexibility in response to emerging scientific findings.
Conclusions:
- RECOVER-Pediatrics aims to provide a comprehensive understanding of PASC in children and young adults.
- The study's findings will contribute to identifying potential therapeutic targets and interventions for pediatric PASC.
- This research is crucial for addressing the long-term health impacts of COVID-19 in younger populations.
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 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.
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 Trials.Gov Identifier:
Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.
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