Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design


Rachel S. Gross, NYU Grossman School of Medicine
Tanayott Thaweethai, Massachusetts General Hospital
Erika B. Rosenzweig, Vagelos College of Physicians and Surgeons
James Chan, Massachusetts General Hospital
Lori B. Chibnik, Massachusetts General Hospital
Mine S. Cicek, Mayo Clinic
Amy J. Elliott, Avera Research Institute
Valerie J. Flaherman, UCSF School of Medicine
Andrea S. Foulkes, Massachusetts General Hospital
Margot Gage Witvliet, Lamar University
Richard Gallagher, NYU Grossman School of Medicine
Maria Laura Gennaro, Public Health Research Institute
Terry L. Jernigan, Department of Cognitive Science
Elizabeth W. Karlson, Harvard Medical School
Stuart D. Katz, NYU Grossman School of Medicine
Patricia A. Kinser, Virginia Commonwealth University
Lawrence C. Kleinman, Rutgers Robert Wood Johnson Medical School at New Brunswick
Michelle F. Lamendola-Essel, NYU Grossman School of Medicine
Joshua D. Milner, Vagelos College of Physicians and Surgeons
Sindhu Mohandas, Keck School of Medicine of USC
Praveen C. Mudumbi, NYU Grossman School of Medicine
Jane W. Newburger, Boston Children's Hospital
Kyung E. Rhee, Department of Pediatrics
Amy L. Salisbury, Virginia Commonwealth University
Jessica N. Snowden, University of Arkansas for Medical Sciences
Cheryl R. Stein, NYU Grossman School of Medicine
Melissa S. Stockwell, Vagelos College of Physicians and Surgeons
Kelan G. Tantisira, Department of Pediatrics
Tamara Bradford, LSU Health Sciences Center - New OrleansFollow
et al

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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.

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5 May


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