Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design.
<h4>Importance</h4>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 trea...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2024-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0285635&type=printable |
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| author | Rachel S Gross Tanayott Thaweethai Erika B Rosenzweig James Chan Lori B Chibnik Mine S Cicek Amy J 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 N 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-Abele C Bind Amanda L Bogie Tamara 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 Handler Ashraf S Harahsheh Keren Hasbani Andrew C Heath Camden Hebson Mary M Heitzeg Christina M Hester Sophia Hill Laura Hobart-Porter Travis K F Hong Carol R Horowitz Daniel S Hsia Matthew Huentelman Kathy D Hummel Katherine Irby Joanna Jacobus Vanessa L Jacoby Pei-Ni Jone David C Kaelber Tyler J Kasmarcak Matthew J Kluko Jessica S Kosut Angela R Laird Jeremy Landeo-Gutierrez Sean M Lang Christine L Larson Peter Paul C Lim Krista M Lisdahl Brian W McCrindle Russell J McCulloh Kimberly McHugh Alan L Mendelsohn Torri D Metz Julie Miller Elizabeth C 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 G Randall Suchitra Rao Harrison T Reeder Johana M Rosas Mark W Russell Arash A 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 M Udosen Megan R Warner Sara E Watson Alan Werzberger Jordan C Weyer Marion J Wood H Shonna Yin William T Zempsky Emily Zimmerman Benard P Dreyer RECOVER-Pediatric Consortium |
| author_facet | Rachel S Gross Tanayott Thaweethai Erika B Rosenzweig James Chan Lori B Chibnik Mine S Cicek Amy J 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 N 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-Abele C Bind Amanda L Bogie Tamara 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 Handler Ashraf S Harahsheh Keren Hasbani Andrew C Heath Camden Hebson Mary M Heitzeg Christina M Hester Sophia Hill Laura Hobart-Porter Travis K F Hong Carol R Horowitz Daniel S Hsia Matthew Huentelman Kathy D Hummel Katherine Irby Joanna Jacobus Vanessa L Jacoby Pei-Ni Jone David C Kaelber Tyler J Kasmarcak Matthew J Kluko Jessica S Kosut Angela R Laird Jeremy Landeo-Gutierrez Sean M Lang Christine L Larson Peter Paul C Lim Krista M Lisdahl Brian W McCrindle Russell J McCulloh Kimberly McHugh Alan L Mendelsohn Torri D Metz Julie Miller Elizabeth C 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 G Randall Suchitra Rao Harrison T Reeder Johana M Rosas Mark W Russell Arash A 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 M Udosen Megan R Warner Sara E Watson Alan Werzberger Jordan C Weyer Marion J Wood H Shonna Yin William T Zempsky Emily Zimmerman Benard P Dreyer RECOVER-Pediatric Consortium |
| author_sort | Rachel S Gross |
| collection | DOAJ |
| description | <h4>Importance</h4>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.<h4>Observations</h4>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.<h4>Conclusions and relevance</h4>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.<h4>Clinical trials.gov identifier</h4>Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011. |
| format | Article |
| id | doaj-art-c4fd3a380ba64f30a6710efe3a6878bd |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-c4fd3a380ba64f30a6710efe3a6878bd2025-01-21T05:31:28ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01195e028563510.1371/journal.pone.0285635Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design.Rachel S GrossTanayott ThaweethaiErika B RosenzweigJames ChanLori B ChibnikMine S CicekAmy J ElliottValerie J FlahermanAndrea S FoulkesMargot Gage WitvlietRichard GallagherMaria Laura GennaroTerry L JerniganElizabeth W KarlsonStuart D KatzPatricia A KinserLawrence C KleinmanMichelle F Lamendola-EsselJoshua D MilnerSindhu MohandasPraveen C MudumbiJane W NewburgerKyung E RheeAmy L SalisburyJessica N SnowdenCheryl R SteinMelissa S StockwellKelan G TantisiraMoriah E ThomasonDongngan T TruongDavid WarburtonJohn C WoodShifa AhmedAlmary AkerlundhAkram N AlshawabkehBrett R AndersonJudy L AschnerAndrew M AtzRobin L AupperleFiona C BakerVenkataraman BalaramanDithi BanerjeeDeanna M BarchArielle Baskin-SommersSultana BhuiyanMarie-Abele C BindAmanda L BogieTamara BradfordNatalie C BuchbinderElliott BuelerHülya BükülmezB J CaseyLinda ChangMaryanne ChrisantDuncan B ClarkRebecca G CliftonKatharine N ClouserLesley CottrellKelly CowanViren D'SaMirella DaprettoSoham DasguptaWalter DehorityAudrey DionneKirsten B DummerMatthew D EliasShari Esquenazi-KaronikaDanielle N EvansE Vincent S FaustinoAlexander G FiksDaniel ForshaJohn J FoxeNaomi P FriedmanGreta FrySunanda GaurDylan G GeeKevin M GrayStephanie HandlerAshraf S HarahshehKeren HasbaniAndrew C HeathCamden HebsonMary M HeitzegChristina M HesterSophia HillLaura Hobart-PorterTravis K F HongCarol R HorowitzDaniel S HsiaMatthew HuentelmanKathy D HummelKatherine IrbyJoanna JacobusVanessa L JacobyPei-Ni JoneDavid C KaelberTyler J KasmarcakMatthew J KlukoJessica S KosutAngela R LairdJeremy Landeo-GutierrezSean M LangChristine L LarsonPeter Paul C LimKrista M LisdahlBrian W McCrindleRussell J McCullohKimberly McHughAlan L MendelsohnTorri D MetzJulie MillerElizabeth C MitchellLerraughn M MorganEva M Müller-OehringErica R NahinMichael C NealeManette Ness-CochinwalaSheila M NolanCarlos R OliveiraOnyekachukwu OsakweMatthew E OsterR Mark PayneMichael A PortmanHengameh RaissyIsabelle G RandallSuchitra RaoHarrison T ReederJohana M RosasMark W RussellArash A SabatiYamuna SanilAlice I SatoMichael S SchechterRangaraj SelvaranganS Kristen Sexson TejtelDivya ShaktiKavita SharmaLindsay M SquegliaShubika SrivastavaMichelle D StevensonJacqueline SzmuszkoviczMaria M Talavera-BarberRonald J TeufelDeepika ThackerFelicia TrachtenbergMmekom M UdosenMegan R WarnerSara E WatsonAlan WerzbergerJordan C WeyerMarion J WoodH Shonna YinWilliam T ZempskyEmily ZimmermanBenard P DreyerRECOVER-Pediatric Consortium<h4>Importance</h4>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.<h4>Observations</h4>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.<h4>Conclusions and relevance</h4>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.<h4>Clinical trials.gov identifier</h4>Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0285635&type=printable |
| spellingShingle | Rachel S Gross Tanayott Thaweethai Erika B Rosenzweig James Chan Lori B Chibnik Mine S Cicek Amy J 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 N 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-Abele C Bind Amanda L Bogie Tamara 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 Handler Ashraf S Harahsheh Keren Hasbani Andrew C Heath Camden Hebson Mary M Heitzeg Christina M Hester Sophia Hill Laura Hobart-Porter Travis K F Hong Carol R Horowitz Daniel S Hsia Matthew Huentelman Kathy D Hummel Katherine Irby Joanna Jacobus Vanessa L Jacoby Pei-Ni Jone David C Kaelber Tyler J Kasmarcak Matthew J Kluko Jessica S Kosut Angela R Laird Jeremy Landeo-Gutierrez Sean M Lang Christine L Larson Peter Paul C Lim Krista M Lisdahl Brian W McCrindle Russell J McCulloh Kimberly McHugh Alan L Mendelsohn Torri D Metz Julie Miller Elizabeth C 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 G Randall Suchitra Rao Harrison T Reeder Johana M Rosas Mark W Russell Arash A 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 M Udosen Megan R Warner Sara E Watson Alan Werzberger Jordan C Weyer Marion J Wood H Shonna Yin William T Zempsky Emily Zimmerman Benard P Dreyer RECOVER-Pediatric Consortium Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. PLoS ONE |
| title | Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. |
| title_full | Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. |
| title_fullStr | Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. |
| title_full_unstemmed | Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. |
| title_short | Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. |
| title_sort | researching covid to enhance recovery recover pediatric study protocol rationale objectives and design |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0285635&type=printable |
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feliciatrachtenberg researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT mmekommudosen researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT meganrwarner researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT saraewatson researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT alanwerzberger researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT jordancweyer researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT marionjwood researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT hshonnayin researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT williamtzempsky researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT emilyzimmerman researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT benardpdreyer researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign AT recoverpediatricconsortium researchingcovidtoenhancerecoveryrecoverpediatricstudyprotocolrationaleobjectivesanddesign |