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

Rachel S. Gross, Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, United States of America.
Tanayott Thaweethai, Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Erika B. Rosenzweig, Division of Pediatric Cardiology, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian, New York, New York, United States of America.
James Chan, Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Lori B. Chibnik, Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Mine S. Cicek, Department of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Rochester, Minnesota, United States of America.
Amy J. Elliott, Avera Research Institute, Avera Health, Sioux Falls, South Dakota, United States of America.
Valerie J. Flaherman, Department of Pediatrics, University of California San Francisco, San Francisco, California, United States of America.
Andrea S. Foulkes, Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Margot Gage Witvliet, Department of Sociology, Lamar University, Beaumont, Texas, United States of America.
Richard Gallagher, Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, New York, United States of America.
Maria Laura Gennaro, Public Health Research Institute and Department of Medicine, Rutgers New Jersey Medical School, Newark, New Jersey, United States of America.
Terry L. Jernigan, Center for Human Development, Department of Cognitive Science, University of California San Diego, San Diego, California, United States of America.
Elizabeth W. Karlson, Department of Medicine, Harvard Medical School, Boston, Massachusetts, United States of America.
Stuart D. Katz, Department of Medicine, New York University Grossman School of Medicine, New York, New York, United States of America.
Patricia A. Kinser, School of Nursing, Virginia Commonwealth University, Richmond, Virginia, United States of America.
Lawrence C. Kleinman, Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States of America.
Michelle F. Lamendola-Essel, Department of Medicine, New York University Grossman School of Medicine, New York, New York, United States of America.
Joshua D. Milner, Division of Pediatric Allergy, Department of Pediatrics, Immunology and Rheumatology, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian, New York, New York, United States of America.
Sindhu Mohandas, Department of Infectious Diseases, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, United States of America.
Praveen C. Mudumbi, Department of Population Health, New York University Grossman School of Medicine, New York, New York, United States of America.
Jane W. Newburger, Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts, United States of America.
Kyung E. Rhee, Division of Child and Community Health, Department of Pediatrics, University of California San Diego School of Medicine, San Diego, California, United States of America.
Amy L. Salisbury, School of Nursing, Virginia Commonwealth University, Richmond, Virginia, United States of America.
Jessica N. Snowden, Departments of Pediatrics and Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America.
Cheryl R. Stein, Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, New York, United States of America.
Melissa S. Stockwell, Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian, New York, New York, United States of America.
Kelan G. Tantisira, Division of Pediatric Respiratory Medicine, Department of Pediatrics, University of California San Diego School of Medicine, San Diego, California, United States of America.
Moriah E. Thomason, Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, New York, United States of America.
Dongngan T. Truong, Division of Pediatric Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, United States of America.
David Warburton, Division of Neonatology, Department of Pediatrics, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, United States of America.
John C. Wood, Department of Pediatrics and Radiology, Children's Hospital Los Angeles, Los Angeles, California, United States of America.

Document Type

Journal Article

Publication Date

1-1-2024

Journal

PloS one

Volume

19

Issue

5

DOI

10.1371/journal.pone.0285635

Abstract

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.

Department

Epidemiology

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