Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Gross, Rachel; Thaweethai, Tanayott; Rosenzweig, Erika B; Chan, James; Chibnik, Lori B; Cicek, Mine S; Elliott, Amy J; Flaherman, Valerie J; Foulkes, Andrea S; Witvliet, Margot Gage; Gallagher, Richard; Gennaro, Maria Laura; Jernigan, Terry L; Karlson, Elizabeth W; Katz, Stuart D; Kinser, Patricia A; Kleinman, Lawrence C; Lamendola-Essel, Michelle F; Milner, Joshua D; Mohandas, Sindhu; Mudumbi, Praveen C; Newburger, Jane W; Rhee, Kyung E; Salisbury, Amy L; Snowden, Jessica N; Stein, Cheryl R; Stockwell, Melissa S; Tantisira, Kelan G; Thomason, Moriah E; Truong, Dongngan T; Warburton, David; Wood, John C; Ahmed, Shifa; Akerlundh, Almary; Alshawabkeh, Akram N; Anderson, Brett R; Aschner, Judy L; Atz, Andrew M; Aupperle, Robin L; Baker, Fiona C; Balaraman, Venkataraman; Banerjee, Dithi; Barch, Deanna M; Baskin-Sommers, Arielle; Bhuiyan, Sultana; Bind, Marie-Abele C; Bogie, Amanda L; Buchbinder, Natalie C; Bueler, Elliott; Bükülmez, Hülya; Casey, B J; Chang, Linda; Clark, Duncan B; Clifton, Rebecca G; Clouser, Katharine N; Cottrell, Lesley; Cowan, Kelly; D'Sa, Viren; Dapretto, Mirella; Dasgupta, Soham; Dehority, Walter; Dummer, Kirsten B; Elias, Matthew D; Esquenazi-Karonika, Shari; Evans, Danielle N; Faustino, E Vincent S; Fiks, Alexander G; Forsha, Daniel; Foxe, John J; Friedman, Naomi P; Fry, Greta; Gaur, Sunanda; Gee, Dylan G; Gray, Kevin M; Harahsheh, Ashraf S; Heath, Andrew C; Heitzeg, Mary M; Hester, Christina M; Hill, Sophia; Hobart-Porter, Laura; Hong, Travis K F; Horowitz, Carol R; Hsia, Daniel S; Huentelman, Matthew; Hummel, Kathy D; Iacono, William G; Irby, Katherine; Jacobus, Joanna; Jacoby, Vanessa L; Jone, Pei-Ni; Kaelber, David C; Kasmarcak, Tyler J; Kluko, Matthew J; Kosut, Jessica S; Laird, Angela R; Landeo-Gutierrez, Jeremy; Lang, Sean M; Larson, Christine L; Lim, Peter Paul C; Lisdahl, Krista M; McCrindle, Brian W; McCulloh, Russell J; Mendelsohn, Alan L; Metz, Torri D; Morgan, Lerraughn M; Müller-Oehring, Eva M; Nahin, Erica R; Neale, Michael C; Ness-Cochinwala, Manette; Nolan, Sheila M; Oliveira, Carlos R; Oster, Matthew E; Payne, R Mark; Raissy, Hengameh; Randall, Isabelle G; Rao, Suchitra; Reeder, Harrison T; Rosas, Johana M; Russell, Mark W; Sabati, Arash A; Sanil, Yamuna; Sato, Alice I; Schechter, Michael S; Selvarangan, Rangaraj; Shakti, Divya; Sharma, Kavita; Squeglia, Lindsay M; Stevenson, Michelle D; Szmuszkovicz, Jacqueline; Talavera-Barber, Maria M; Teufel, Ronald J; Thacker, Deepika; Udosen, Mmekom M; Warner, Megan R; Watson, Sara E; Werzberger, Alan; Weyer, Jordan C; Wood, Marion J; Yin, H Shonna; Zempsky, William T; Zimmerman, Emily; Dreyer, Benard P
IMPORTANCE/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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 TRIALSGOV IDENTIFIER/UNASSIGNED:Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.
PMID: 37214806
CID: 5770522