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

2024; Public Library of Science; Volume: 19; Issue: 5 Linguagem: Inglês

10.1371/journal.pone.0285635

1932-6203

Rachel S. Gross, Tanayott Thaweethai, Erika B. Rosenzweig, James Chan, Lori B. Chibnik, Mine S. Cicek, Amy Elliott, Valerie J. Flaherman, Andrea S. Foulkes, Margot Gage Witvliet, Richard Gallagher, Maria Laura Gennaro, Terry L. Jernigan, Elizabeth W. Karlson, Stuart D. Katz, Patricia A. Kinser, Lawrence C. Kleinman, Michelle F. Lamendola-Essel, Joshua D. Milner, Sindhu Mohandas, Praveen C. Mudumbi, Jane W. Newburger, Kyung E. Rhee, Amy L. Salisbury, Jessica Snowden, Cheryl R. Stein, Melissa S. Stockwell, Kelan G. Tantisira, Moriah E. Thomason, Dongngan T. Truong, David Warburton, John C. Wood, Shifa Ahmed, Almary Akerlundh, Akram N. Alshawabkeh, Brett R. Anderson, Judy L. Aschner, Andrew M. Atz, Robin L. Aupperle, Fiona C. Baker, Venkataraman Balaraman, Dithi Banerjee, Deanna M. Barch, Arielle Baskin–Sommers, Sultana Bhuiyan, Marie‐Abèle Bind, Amanda Bogie, Tamara T. Bradford, Natalie C. Buchbinder, Elliott Bueler, Hülya Bükülmez, B.J. Casey, Linda Chang, Maryanne Chrisant, Duncan B. Clark, Rebecca G. Clifton, Katharine N. Clouser, Lesley Cottrell, Kelly Cowan, Viren D’Sa, Mirella Dapretto, Soham Dasgupta, Walter Dehority, Audrey Dionne, Kirsten B. Dummer, Matthew D. Elias, Shari Esquenazi‐Karonika, Danielle N. Evans, E. Vincent S. Faustino, Alexander G. Fiks, Daniel Forsha, John J. Foxe, Naomi P. Friedman, Greta Fry, Sunanda Gaur, Dylan G. Gee, Kevin M. Gray, Stephanie S. Handler, Ashraf S. Harahsheh, Keren Hasbani, Andrew C. Heath, Camden L. Hebson, Mary M. Heitzeg, Christina M. Hester, Sophia Hill, Laura Hobart‐Porter, Travis K.F. Hong, Carol R. Horowitz, Daniel S. Hsia, Matthew J. Huentelman, Kathy D. Hummel, Katherine Irby, Joanna Jacobus, Vanessa L. Jacoby, Pei‐Ni Jone, David C. Kaelber, Tyler Kasmarcak, Matthew J. Kluko, Jessica S. Kosut, Angela R. Laird, Jeremy Landeo‐Gutierrez, Sean M. Lang, Christine L. Larson, Peter Paul Lim, Krista M. Lisdahl, Brian W. McCrindle, Russell J. McCulloh, Kimberly E. McHugh, Alan L. Mendelsohn, Torri D. Metz, Julie Miller, Elizabeth Mitchell, Lerraughn M. Morgan, Eva M. Müller‐Oehring, Erica R. Nahin, Michael C. Neale, Manette Ness-Cochinwala, Sheila M. Nolan, Carlos R. Oliveira, Onyekachukwu Osakwe, Matthew E. Oster, R. Mark Payne, Michael A. Portman, Hengameh Raissy, Isabelle Randall, Suchitra Rao, Harrison T. Reeder, Johana Rosas, Mark W. Russell, Arash Sabati, Yamuna Sanil, Alice I. Sato, Michael S. Schechter, Rangaraj Selvarangan, S. Kristen Sexson Tejtel, Divya Shakti, Kavita Sharma, Lindsay M. Squeglia, Shubika Srivastava, Michelle D. Stevenson, Jacqueline Szmuszkovicz, Maria M. Talavera‐Barber, Ronald J. Teufel, Deepika Thacker, Felicia Trachtenberg, Mmekom Udosen, Megan R. Warner, Sara Watson, Alan Werzberger, Jordan C. Weyer, Marion J. Wood, H. Shonna Yin, William T. Zempsky, Emily Zimmerman, Benard P. Dreyer,

Childhood Cancer Survivors' Quality of Life

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 RE searching COV ID to E nhance R ecovery (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 .