Dataset Information

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design.

ABSTRACT:

Importance

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.

Registration

NCT05172024.

SUBMITTER: Horwitz LI

PROVIDER: S-EPMC10289397 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design.

Horwitz Leora I LI Thaweethai Tanayott T Brosnahan Shari B SB Cicek Mine S MS Fitzgerald Megan L ML Goldman Jason D JD Hess Rachel R Hodder S L SL Jacoby Vanessa L VL Jordan Michael R MR Krishnan Jerry A JA Laiyemo Adeyinka O AO Metz Torri D TD Nichols Lauren L Patzer Rachel E RE Sekar Anisha A Singer Nora G NG Stiles Lauren E LE Taylor Barbara S BS Ahmed Shifa S Algren Heather A HA Anglin Khamal K Aponte-Soto Lisa L Ashktorab Hassan H Bassett Ingrid V IV Bedi Brahmchetna B Bhadelia Nahid N Bime Christian C Bind Marie-Abele C MC Black Lora J LJ Blomkalns Andra L AL Brim Hassan H Castro Mario M Chan James J Charney Alexander W AW Chen Benjamin K BK Chen Li Qing LQ Chen Peter P Chestek David D Chibnik Lori B LB Chow Dominic C DC Chu Helen Y HY Clifton Rebecca G RG Collins Shelby S Costantine Maged M MM Cribbs Sushma K SK Deeks Steven G SG Dickinson John D JD Donohue Sarah E SE Durstenfeld Matthew S MS Emery Ivette F IF Erlandson Kristine M KM Facelli Julio C JC Farah-Abraham Rachael R Finn Aloke V AV Fischer Melinda S MS Flaherman Valerie J VJ Fleurimont Judes J Fonseca Vivian V Gallagher Emily J EJ Gander Jennifer C JC Gennaro Maria Laura ML Gibson Kelly S KS Go Minjoung M Goodman Steven N SN Granger Joey P JP Greenway Frank L FL Hafner John W JW Han Jenny E JE Harkins Michelle S MS Hauser Kristine S P KSP Heath James R JR Hernandez Carla R CR Ho On O Hoffman Matthew K MK Hoover Susan E SE Horowitz Carol R CR Hsu Harvey H Hsue Priscilla Y PY Hughes Brenna L BL Jagannathan Prasanna P James Judith A JA John Janice J Jolley Sarah S Judd S E SE Juskowich Joy J JJ Kanjilal Diane G DG Karlson Elizabeth W EW Katz Stuart D SD Kelly J Daniel JD Kelly Sara W SW Kim Arthur Y AY Kirwan John P JP Knox Kenneth S KS Kumar Andre A Lamendola-Essel Michelle F MF Lanca Margaret M Lee-Lannotti Joyce K JK Lefebvre R Craig RC Levy Bruce D BD Lin Janet Y JY Logarbo Brian P BP Logue Jennifer K JK Longo Michele T MT Luciano Carlos A CA Lutrick Karen K Malakooti Shahdi K SK Mallett Gail G Maranga Gabrielle G Marathe Jai G JG Marconi Vincent C VC Marshall Gailen D GD Martin Christopher F CF Martin Jeffrey N JN May Heidi T HT McComsey Grace A GA McDonald Dylan D Mendez-Figueroa Hector H Miele Lucio L Mittleman Murray A MA Mohandas Sindhu S Mouchati Christian C Mullington Janet M JM Nadkarni Girish N GN Nahin Erica R ER Neuman Robert B RB Newman Lisa T LT Nguyen Amber A Nikolich Janko Z JZ Ofotokun Igho I Ogbogu Princess U PU Palatnik Anna A Palomares Kristy T S KTS Parimon Tanyalak T Parry Samuel S Parthasarathy Sairam S Patterson Thomas F TF Pearman Ann A Peluso Michael J MJ Pemu Priscilla P Pettker Christian M CM Plunkett Beth A BA Pogreba-Brown Kristen K Poppas Athena A Porterfield J Zachary JZ Quigley John G JG Quinn Davin K DK Raissy Hengameh H Rebello Candida J CJ Reddy Uma M UM Reece Rebecca R Reeder Harrison T HT Rischard Franz P FP Rosas Johana M JM Rosen Clifford J CJ Rouphael Nadine G NG Rouse Dwight J DJ Ruff Adam M AM Saint Jean Christina C Sandoval Grecio J GJ Santana Jorge L JL Schlater Shannon M SM Sciurba Frank C FC Selvaggi Caitlin C Seshadri Sudha S Sesso Howard D HD Shah Dimpy P DP Shemesh Eyal E Sherif Zaki A ZA Shinnick Daniel J DJ Simhan Hyagriv N HN Singh Upinder U Sowles Amber A Subbian Vignesh V Sun Jun J Suthar Mehul S MS Teunis Larissa J LJ Thorp John M JM Ticotsky Amberly A Tita Alan T N ATN Tragus Robin R Tuttle Katherine R KR Urdaneta Alfredo E AE Utz P J PJ VanWagoner Timothy M TM Vasey Andrew A Vernon Suzanne D SD Vidal Crystal C Walker Tiffany T Ward Honorine D HD Warren David E DE Weeks Ryan M RM Weiner Steven J SJ Weyer Jordan C JC Wheeler Jennifer L JL Whiteheart Sidney W SW Wiley Zanthia Z Williams Natasha J NJ Wisnivesky Juan P JP Wood John C JC Yee Lynn M LM Young Natalie M NM Zisis Sokratis N SN Foulkes Andrea S AS

PloS one 20230623 6

<h4>Importance</h4>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) characteriz ...[more]

PMID: 37352211

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Project description:ImportanceThe 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.ObservationsWe 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 relevanceRECOVER-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 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.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.

Project description:BackgroundThere is little scientific evidence to support the usual practice of providing outpatient rehabilitation to patients undergoing total knee replacement surgery (TKR) immediately after discharge from the orthopaedic ward. It is hypothesised that the lack of clinical benefit is due to the low exercise intensity tolerated at this time, with patients still recovering from the effects of major orthopaedic surgery. The aim of the proposed clinical trial is to investigate the clinical and cost effectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed, approximately six weeks later, by higher intensity outpatient exercise classes.Methods/designIn this multicentre randomised controlled trial, 600 patients undergoing primary TKR will be recruited at the orthopaedic pre-admission clinic of 10 large public and private hospitals in Australia. There will be no change to the medical or rehabilitative care usually provided while the participant is admitted to the orthopaedic ward. After TKR, but prior to discharge from the orthopaedic ward, participants will be randomised to either the novel rehabilitation strategy or usual rehabilitative care as provided by the hospital or recommended by the orthopaedic surgeon. Outcomes assessments will be conducted at baseline (pre-admission clinic) and at 6 weeks, 6 months and 12 months following randomisation. The primary outcomes will be self-reported knee pain and physical function. Secondary outcomes include quality of life and objective measures of physical performance. Health economic data (health sector and community service utilisation, loss of productivity) will be recorded prospectively by participants in a patient diary. This patient cohort will also be followed-up annually for five years for knee pain, physical function and the need or actual incidence of further joint replacement surgery.DiscussionThe results of this pragmatic clinical trial can be directly implemented into clinical practice. If beneficial, the novel rehabilitation strategy of utilising outpatient exercise classes during a later rehabilitation phase would provide a feasible and potentially cost-effective intervention to optimise the physical well-being of the large number of people undergoing TKR.Trial registrationACTRN12609000054213.

Dataset Information

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design.

Importance

Methods

Discussion

Registration

Publications

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design.

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