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

Authors

Leora I. Horwitz, NYU Grossman School of Medicine
Tanayott Thaweethai, Massachusetts General Hospital
Shari B. Brosnahan, NYU Langone Health
Mine S. Cicek, Mayo Clinic
Megan L. Fitzgerald, Patient-Led Research Collaborative
Jason D. Goldman, Swedish Medical Center, Seattle
Rachel Hess, University of Utah School of Medicine
S. L. Hodder, West Virginia University School of Medicine Morgantown
Vanessa L. Jacoby, University of California, San Francisco
Michael R. Jordan, Tufts Medical Center
Jerry A. Krishnan, University of Illinois College of Medicine
Adeyinka O. Laiyemo, Howard University College of Medicine
Torri D. Metz, University of Utah School of Medicine
Lauren Nichols, Body Politic COVID-19 Support Group
Rachel E. Patzer, Emory University School of Medicine
Anisha Sekar, Patient-Led Research Collaborative
Nora G. Singer, MetroHealth Medical Center Cleveland
Lauren E. Stiles, Renaissance School of Medicine at Stony Brook University
Barbara S. Taylor, Joe R. & Teresa Lozano Long School of Medicine
Shifa Ahmed, Massachusetts General Hospital
Heather A. Algren, Swedish Medical Center, Seattle
Khamal Anglin, University of California, San Francisco
Lisa Aponte-Soto, DePaul University
Hassan Ashktorab, Howard University College of Medicine
Ingrid V. Bassett, Harvard Medical School
Brahmchetna Bedi, Emory University School of Medicine
Nahid Bhadelia, Boston University Chobanian & Avedisian School of Medicine
Christian Bime, University of Arizona College of Medicine – Tucson
Marie Abele C. Bind, Massachusetts General Hospital
Lora J. Black, Sanford Health
Andra L. Blomkalns, Stanford University
Hassan Brim, Howard University
Mario Castro, University of Kansas Medical Center
James Chan, Massachusetts General Hospital

Document Type

Article

Publication Date

6-1-2023

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.

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