Dataset Information

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

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 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 five 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 trialsgov identifier

Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.

SUBMITTER: Gross R

PROVIDER: S-EPMC10197716 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

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

Gross Rachel R Thaweethai Tanayott T Rosenzweig Erika B EB Chan James J Chibnik Lori B LB Cicek Mine S MS Elliott Amy J AJ Flaherman Valerie J VJ Foulkes Andrea S AS Witvliet Margot Gage MG Gallagher Richard R Gennaro Maria Laura ML Jernigan Terry L TL Karlson Elizabeth W EW Katz Stuart D SD Kinser Patricia A PA Kleinman Lawrence C LC Lamendola-Essel Michelle F MF Milner Joshua D JD Mohandas Sindhu S Mudumbi Praveen C PC Newburger Jane W JW Rhee Kyung E KE Salisbury Amy L AL Snowden Jessica N JN Stein Cheryl R CR Stockwell Melissa S MS Tantisira Kelan G KG Thomason Moriah E ME Truong Dongngan T DT Warburton David D Wood John C JC Ahmed Shifa S Akerlundh Almary A Alshawabkeh Akram N AN Anderson Brett R BR Aschner Judy L JL Atz Andrew M AM Aupperle Robin L RL Baker Fiona C FC Balaraman Venkataraman V Banerjee Dithi D Barch Deanna M DM Baskin-Sommers Arielle A Bhuiyan Sultana S Bind Marie-Abele C MC Bogie Amanda L AL Buchbinder Natalie C NC Bueler Elliott E Bükülmez Hülya H Casey B J BJ Chang Linda L Clark Duncan B DB Clifton Rebecca G RG Clouser Katharine N KN Cottrell Lesley L Cowan Kelly K D'Sa Viren V Dapretto Mirella M Dasgupta Soham S Dehority Walter W Dummer Kirsten B KB Elias Matthew D MD Esquenazi-Karonika Shari S Evans Danielle N DN Faustino E Vincent S EVS Fiks Alexander G AG Forsha Daniel D Foxe John J JJ Friedman Naomi P NP Fry Greta G Gaur Sunanda S Gee Dylan G DG Gray Kevin M KM Harahsheh Ashraf S AS Heath Andrew C AC Heitzeg Mary M MM Hester Christina M CM Hill Sophia S Hobart-Porter Laura L Hong Travis K F TKF Horowitz Carol R CR Hsia Daniel S DS Huentelman Matthew M Hummel Kathy D KD Iacono William G WG Irby Katherine K Jacobus Joanna J Jacoby Vanessa L VL Jone Pei-Ni PN Kaelber David C DC Kasmarcak Tyler J TJ Kluko Matthew J MJ Kosut Jessica S JS Laird Angela R AR Landeo-Gutierrez Jeremy J Lang Sean M SM Larson Christine L CL Lim Peter Paul C PPC Lisdahl Krista M KM McCrindle Brian W BW McCulloh Russell J RJ Mendelsohn Alan L AL Metz Torri D TD Morgan Lerraughn M LM Müller-Oehring Eva M EM Nahin Erica R ER Neale Michael C MC Ness-Cochinwala Manette M Nolan Sheila M SM Oliveira Carlos R CR Oster Matthew E ME Payne R Mark RM Raissy Hengameh H Randall Isabelle G IG Rao Suchitra S Reeder Harrison T HT Rosas Johana M JM Russell Mark W MW Sabati Arash A AA Sanil Yamuna Y Sato Alice I AI Schechter Michael S MS Selvarangan Rangaraj R Shakti Divya D Sharma Kavita K Squeglia Lindsay M LM Stevenson Michelle D MD Szmuszkovicz Jacqueline J Talavera-Barber Maria M MM Teufel Ronald J RJ Thacker Deepika D Udosen Mmekom M MM Warner Megan R MR Watson Sara E SE Werzberger Alan A Weyer Jordan C JC Wood Marion J MJ Yin H Shonna HS Zempsky William T WT Zimmerman Emily E Dreyer Benard P BP

medRxiv : the preprint server for health sciences 20230512

<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 <b>RE</b> searching <b>COV</b> ID to <b>E</b> nhance <b>R</b> ecovery (RECO ...[more]

PMID: 37214806

Similar Datasets

Project description:ImportanceSARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis.MethodsRECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms.DiscussionRECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.RegistrationNCT05172024.

Project description:ImportancePregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads.MethodsRECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators.DiscussionRECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero.Clinical trials.gov identifierClinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.

Project description:ImportancePregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER- Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads.MethodsRECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators.DiscussionRECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero.RegistrationNCT05172024.

Dataset Information

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

Importance

Observations

Conclusions and relevance

Clinical trialsgov identifier

Publications

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

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