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

• DOI: 10.1371/journal.pone.0286297
• Publication Date: 2023-06-24T06:33:58Z
• Authors: Leora I. Horwitz; Tanayott Thaweethai; Shari B. Brosnahan; Mine S. Cicek; Megan L. Fitzgerald; Jason D. Goldman; Rachel Hess; S. L. Hodder; Vanessa L. Jacoby; Michael R. Jordan; Jerry A. Krishnan; Adeyinka O. Laiyemo; Torri D. Metz; Lauren Nichols; Rachel E. Patzer; Anisha Sekar; Nora G. Singer; Lauren E. Stiles; Barbara S. Taylor; Shifa Ahmed; Heather A. Algren; Khamal Anglin; Lisa Aponte-Soto; Hassan Ashktorab; Ingrid V. Bassett; Brahmchetna Bedi; Nahid Bhadelia; Christian Bime; Marie-Abele C. Bind; Lora J. Black; Andra L. Blomkalns; Hassan Brim; Mario Castro; James Chan; Alexander W. Charney; Benjamin K. Chen; Li Qing Chen; Peter Chen; David Chestek; Lori B. Chibnik; Dominic C. Chow; Helen Y. Chu; Rebecca G. Clifton; Shelby Collins; Maged M. Costantine; Sushma K. Cribbs; Steven G. Deeks; John D. Dickinson; Sarah E. Donohue; Matthew S. Durste...; Ivette F. Emery; Kristine M. Erlan...; Julio C. Facelli; Rachael Farah-Abr...; Aloke V. Finn; Melinda S. Fischer; Valerie J. Flaherman; Judes Fleurimont; Vivian Fonseca; Emily J. Gallagher; Jennifer C. Gander; Maria Laura Gennaro; Kelly S. Gibson; Minjoung Go; Steven N. Goodman; Joey P. Granger; Frank L. Greenway; John W. Hafner; Jenny E. Han; Michelle S. Harkins; Kristine S. P. Ha...; James R. Heath; Carla R. Hernandez; On Ho; Matthew K. Hoffman; Susan E. Hoover; Carol R. Horowitz; Harvey Hsu; Priscilla Y. Hsue; Brenna L. Hughes; Prasanna Jagannathan; Judith A. James; Janice John; Sarah Jolley; S. E. Judd; Joy J. Juskowich; Diane G. Kanjilal; Elizabeth W. Karlson; Stuart D. Katz; J. Daniel Kelly; Sara W. Kelly; Arthur Y. Kim; John P. Kirwan; Kenneth S. Knox; Andre Kumar; Michelle F. Lamen...; Margaret Lanca; Joyce K. Lee-lann...; R. Craig Lefebvre; Bruce D. Levy; Janet Y. Lin; Brian P. Logarbo; Jennifer K. Logue; Michele T. Longo; Carlos A. Luciano; Karen Lutrick; Shahdi K. Malakooti; Gail Mallett; Gabrielle Maranga; Jai G. Marathe; Vincent C. Marconi; Gailen D. Marshall; Christopher F. Ma...; Jeffrey N. Martin; Heidi T. May; Grace A. McComsey; Dylan McDonald; Hector Mendez-Fig...; Lucio Miele; Murray A. Mittleman; Sindhu Mohandas; Christian Mouchati; Janet M. Mullington; Girish N. Nadkarni; Erica R. Nahin; Robert B. Neuman; Lisa T. Newman; Amber Nguyen; Janko Z. Nikolich; Igho Ofotokun; Princess U. Ogbogu; Anna Palatnik; Kristy T. S. Palo...; Tanyalak Parimon; Samuel Parry; Sairam Parthasarathy; Thomas F. Patterson; Ann Pearman; Michael J. Peluso; Priscilla Pemu; Christian M. Pettker; Beth A. Plunkett; Kristen Pogreba-B...; Athena Poppas; J. Zachary Porter...; John G. Quigley; Davin K. Quinn; Hengameh Raissy; Candida J. Rebello; Uma M. Reddy; Rebecca Reece; Harrison T. Reeder; Franz P. Rischard; Johana M. Rosas; Clifford J. Rosen; Nadine G. Rouphael; Dwight J. Rouse; Adam M. Ruff; Christina Saint Jean; Grecio J. Sandoval; Jorge L. Santana; Shannon M. Schlater; Frank C. Sciurba; Caitlin Selvaggi; Sudha Seshadri; Howard D. Sesso; Dimpy P. Shah; Eyal Shemesh; Zaki A. Sherif; Daniel J. Shinnick; Hyagriv N. Simhan; Upinder Singh; Amber Sowles; Vignesh Subbian; Jun Sun; Mehul S. Suthar; Larissa J. Teunis; John M. Thorp; Amberly Ticotsky; Alan T. N. Tita; Robin Tragus; Katherine R. Tuttle; Alfredo E. Urdaneta; P. J. Utz; Timothy M. VanWag...; Andrew Vasey; Suzanne D. Vernon; Crystal Vidal; Tiffany Walker; Honorine D. Ward; David E. Warren; Ryan M. Weeks; Steven J. Weiner; Jordan C. Weyer; Jennifer L. Wheeler; Sidney W. Whiteheart; Zanthia Wiley; Natasha J. Williams; Juan P. Wisnivesky; John C. Wood; Lynn M. Yee; Natalie M. Young; Sokratis N. Zisis; Andrea S. Foulkes
• Keywords: 2019-20 coronavirus outbreak; Protocol design; Betacoronavirus; Pandemic; Coronavirus Infections

Importance SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms other health effects after the acute phase of infection; termed post-acute sequelae (PASC), long COVID. The characteristics, prevalence, trajectory and mechanisms PASC are ill-defined. objectives Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study Adults (RECOVER-Adult) to: (1) characterize prevalence; (2) symptoms, organ dysfunction, natural history, distinct phenotypes PASC; (3) identify demographic, social clinical risk factors for onset recovery; (4) define biological underlying pathogenesis. Methods RECOVER-Adult is a combined prospective/retrospective cohort currently planned enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria suspected, probable, confirmed have evidence no prior infection. Recruitment occurs at 86 sites 33 U.S. states, Washington, DC Puerto Rico, via facility- community-based outreach. Participants complete quarterly questionnaires about determinants, vaccination status, interim infections. In addition, contribute biospecimens undergo physical laboratory examinations approximately 0, 90 180 days from negative test date, yearly thereafter. Some additional testing based on specific random sampling. Patient representatives provide input all study processes. primary outcome PASC, measured by signs symptoms. A paradigm identifying cases will be defined updated using supervised unsupervised learning approaches with cross-validation. Logistic regression proportional hazards conducted investigate associations between factors, onset, resolution Discussion first national, prospective, longitudinal among US adults. Results this intended inform public health, spur trials, expand treatment options. Registration NCT05172024 .