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

dc.contributor.authorGross, Rachel
dc.contributor.authorThaweethai, Tanayott
dc.contributor.authorRosenzweig, Erika B.
dc.contributor.authorChan, James
dc.contributor.authorChibnik, Lori B.
dc.contributor.authorCicek, Mine S.
dc.contributor.authorElliott, Amy J.
dc.contributor.authorFlaherman, Valerie J.
dc.contributor.authorFoulkes, Andrea S.
dc.contributor.authorWitvliet, Margot Gage
dc.contributor.authorGallagher, Richard
dc.contributor.authorGennaro, Maria Laura
dc.contributor.authorJernigan, Terry L.
dc.contributor.authorKarlson, Elizabeth W.
dc.contributor.authorKatz, Stuart D.
dc.contributor.authorKinser, Patricia A.
dc.contributor.authorKleinman, Lawrence C.
dc.contributor.authorLamendola-Essel, Michelle F.
dc.contributor.authorMilner, Joshua D.
dc.contributor.authorMohandas, Sindhu
dc.contributor.authorMudumbi, Praveen C.
dc.contributor.authorNewburger, Jane W.
dc.contributor.authorRhee, Kyung E.
dc.contributor.authorSalisbury, Amy L.
dc.contributor.authorSnowden, Jessica N.
dc.contributor.authorStein, Cheryl R.
dc.contributor.authorStockwell, Melissa S.
dc.contributor.authorTantisira, Kelan G.
dc.contributor.authorThomason, Moriah E.
dc.contributor.authorTruong, Dongngan T.
dc.contributor.authorWarburton, David
dc.contributor.authorWood, John C.
dc.contributor.authorAhmed, Shifa
dc.contributor.authorAkerlundh, Almary
dc.contributor.authorAlshawabkeh, Akram N.
dc.contributor.authorAnderson, Brett R.
dc.contributor.authorAschner, Judy L.
dc.contributor.authorAtz, Andrew M.
dc.contributor.authorAupperle, Robin L.
dc.contributor.authorBaker, Fiona C.
dc.contributor.authorBalaraman, Venkataraman
dc.contributor.authorBanerjee, Dithi
dc.contributor.authorBarch, Deanna M.
dc.contributor.authorBaskin-Sommers, Arielle
dc.contributor.authorBhuiyan, Sultana
dc.contributor.authorBind, Marie-Abele C.
dc.contributor.authorBogie, Amanda L.
dc.contributor.authorBuchbinder, Natalie C.
dc.contributor.authorBueler, Elliott
dc.contributor.authorBükülmez, Hülya
dc.contributor.authorCasey, B. J.
dc.contributor.authorChang, Linda
dc.contributor.authorClark, Duncan B.
dc.contributor.authorClifton, Rebecca G.
dc.contributor.authorClouser, Katharine N.
dc.contributor.authorCottrell, Lesley
dc.contributor.authorCowan, Kelly
dc.contributor.authorD'Sa, Viren
dc.contributor.authorDapretto, Mirella
dc.contributor.authorDasgupta, Soham
dc.contributor.authorDehority, Walter
dc.contributor.authorDummer, Kirsten B.
dc.contributor.authorElias, Matthew D.
dc.contributor.authorEsquenazi-Karonika, Shari
dc.contributor.authorEvans, Danielle N.
dc.contributor.authorFaustino, E. Vincent S.
dc.contributor.authorFiks, Alexander G.
dc.contributor.authorForsha, Daniel
dc.contributor.authorFoxe, John J.
dc.contributor.authorFriedman, Naomi P.
dc.contributor.authorFry, Greta
dc.contributor.authorGaur, Sunanda
dc.contributor.authorGee, Dylan G.
dc.contributor.authorGray, Kevin M.
dc.contributor.authorHarahsheh, Ashraf S.
dc.contributor.authorHeath, Andrew C.
dc.contributor.authorHeitzeg, Mary M.
dc.contributor.authorHester, Christina M.
dc.contributor.authorHill, Sophia
dc.contributor.authorHobart-Porter, Laura
dc.contributor.authorHong, Travis K. F.
dc.contributor.authorHorowitz, Carol R.
dc.contributor.authorHsia, Daniel S.
dc.contributor.authorHuentelman, Matthew
dc.contributor.authorHummel, Kathy D.
dc.contributor.authorIacono, William G.
dc.contributor.authorIrby, Katherine
dc.contributor.authorJacobus, Joanna
dc.contributor.authorJacoby, Vanessa L.
dc.contributor.authorJone, Pei-Ni
dc.contributor.authorKaelber, David C.
dc.contributor.authorKasmarcak, Tyler J.
dc.contributor.authorKluko, Matthew J.
dc.contributor.authorKosut, Jessica S.
dc.contributor.authorLaird, Angela R.
dc.contributor.authorLandeo-Gutierrez, Jeremy
dc.contributor.authorLang, Sean M.
dc.contributor.authorLarson, Christine L.
dc.contributor.authorLim, Peter Paul C.
dc.contributor.authorLisdahl, Krista M.
dc.contributor.authorMcCrindle, Brian W.
dc.contributor.authorMcCulloh, Russell J.
dc.contributor.authorMendelsohn, Alan L.
dc.contributor.authorMetz, Torri D.
dc.contributor.authorMorgan, Lerraughn M.
dc.contributor.authorMüller-Oehring, Eva M.
dc.contributor.authorNahin, Erica R.
dc.contributor.authorNeale, Michael C.
dc.contributor.authorNess-Cochinwala, Manette
dc.contributor.authorNolan, Sheila M.
dc.contributor.authorOliveira, Carlos R.
dc.contributor.authorOster, Matthew E.
dc.contributor.authorPayne, R. Mark
dc.contributor.authorRaissy, Hengameh
dc.contributor.authorRandall, Isabelle G.
dc.contributor.authorRao, Suchitra
dc.contributor.authorReeder, Harrison T.
dc.contributor.authorRosas, Johana M.
dc.contributor.authorRussell, Mark W.
dc.contributor.authorSabati, Arash A.
dc.contributor.authorSanil, Yamuna
dc.contributor.authorSato, Alice I.
dc.contributor.authorSchechter, Michael S.
dc.contributor.authorSelvarangan, Rangaraj
dc.contributor.authorShakti, Divya
dc.contributor.authorSharma, Kavita
dc.contributor.authorSqueglia, Lindsay M.
dc.contributor.authorStevenson, Michelle D.
dc.contributor.authorSzmuszkovicz, Jacqueline
dc.contributor.authorTalavera-Barber, Maria M.
dc.contributor.authorTeufel, Ronald J., II
dc.contributor.authorThacker, Deepika
dc.contributor.authorUdosen, Mmekom M.
dc.contributor.authorWarner, Megan R.
dc.contributor.authorWatson, Sara E.
dc.contributor.authorWerzberger, Alan
dc.contributor.authorWeyer, Jordan C.
dc.contributor.authorWood, Marion J.
dc.contributor.authorYin, H. Shonna
dc.contributor.authorZempsky, William T.
dc.contributor.authorZimmerman, Emily
dc.contributor.authorDreyer, Benard P.
dc.contributor.departmentPediatrics, School of Medicine
dc.date.accessioned2024-01-10T15:25:35Z
dc.date.available2024-01-10T15:25:35Z
dc.date.issued2023-06-23
dc.description.abstractImportance: SARS-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. Methods: RECOVER-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. Discussion: RECOVER-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.
dc.eprint.versionFinal published version
dc.identifier.citationHorwitz LI, Thaweethai T, Brosnahan SB, et al. Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design. PLoS One. 2023;18(6):e0286297. Published 2023 Jun 23. doi:10.1371/journal.pone.0286297
dc.identifier.urihttps://hdl.handle.net/1805/37932
dc.language.isoen_US
dc.publisherPublic Library of Science
dc.relation.isversionof10.1371/journal.pone.0286297
dc.relation.journalPLoS One
dc.rightsAttribution 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourcePMC
dc.subjectCOVID-19
dc.subjectPost-Acute COVID-19 Syndrome
dc.subjectSARS-CoV-2
dc.titleResearching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
dc.typeArticle
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