TY - JOUR
T1 - Researching COVID to enhance recovery (RECOVER) pediatric study protocol
T2 - Rationale, objectives and design
AU - RECOVER-Pediatric Consortium
AU - Gross, Rachel S.
AU - Thaweethai, Tanayott
AU - Rosenzweig, Erika B.
AU - Chan, James
AU - Chibnik, Lori B.
AU - Cicek, Mine S.
AU - Elliott, Amy J.
AU - Flaherman, Valerie J.
AU - Foulkes, Andrea S.
AU - Witvliet, Margot Gage
AU - Gallagher, Richard
AU - Gennaro, Maria Laura
AU - Jernigan, Terry L.
AU - Karlson, Elizabeth W.
AU - Katz, Stuart D.
AU - Kinser, Patricia A.
AU - Kleinman, Lawrence C.
AU - Lamendola-Essel, Michelle F.
AU - Milner, Joshua D.
AU - Mohandas, Sindhu
AU - Mudumbi, Praveen C.
AU - Newburger, Jane W.
AU - Rhee, Kyung E.
AU - Salisbury, Amy L.
AU - Snowden, Jessica N.
AU - Stein, Cheryl R.
AU - Stockwell, Melissa S.
AU - Tantisira, Kelan G.
AU - Thomason, Moriah E.
AU - Truong, Dongngan T.
AU - Warburton, David
AU - Wood, John C.
AU - Ahmed, Shifa
AU - Akerlundh, Almary
AU - Alshawabkeh, Akram N.
AU - Anderson, Brett R.
AU - Aschner, Judy L.
AU - Atz, Andrew M.
AU - Aupperle, Robin L.
AU - Baker, Fiona C.
AU - Balaraman, Venkataraman
AU - Banerjee, Dithi
AU - Barch, Deanna M.
AU - Baskin-Sommers, Arielle
AU - Bhuiyan, Sultana
AU - Bind, Marie Abele C.
AU - Bogie, Amanda L.
AU - Bradford, Tamara
AU - Srivastava, Shubika
AU - Thacker, Deepika
N1 - Publisher Copyright:
© 2024 Public Library of Science. All rights reserved.
PY - 2024/5
Y1 - 2024/5
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - COVID-19/epidemiology
KW - Child
KW - Child, Preschool
KW - Cohort Studies
KW - Female
KW - Humans
KW - Infant
KW - Infant, Newborn
KW - Male
KW - Post-Acute COVID-19 Syndrome
KW - Prospective Studies
KW - Research Design
KW - SARS-CoV-2/isolation & purification
KW - Young Adult
UR - https://www.scopus.com/pages/publications/85192583721
U2 - 10.1371/journal.pone.0285635
DO - 10.1371/journal.pone.0285635
M3 - Article
C2 - 38713673
AN - SCOPUS:85192583721
SN - 1932-6203
VL - 19
SP - e0285635
JO - PLoS ONE
JF - PLoS ONE
IS - 5
M1 - e0285635
ER -