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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.
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.
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