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

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. Durstenfeld; Ivette F. Emery; Kristine M. Erlandson; Julio C. Facelli; Rachael Farah-Abraham; 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. Hauser; 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. Lamendola-Essel; Margaret Lanca; Joyce K. Lee-Lannotti; 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. Martin; Jeffrey N. Martin; Heidi T. May; Grace A. McComsey; Dylan McDonald; Hector Mendez-Figueroa; 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. Palomares; Tanyalak Parimon; Samuel Parry; Sairam Parthasarathy; Thomas F. Patterson; Ann Pearman; Michael J. Peluso; Priscilla Pemu; Christian M. Pettker; Beth A. Plunkett; Kristen Pogreba-Brown; Athena Poppas; J. Zachary Porterfield; 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. VanWagoner; 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

doi:10.1371/journal.pone.0286297

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

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 AhmedHeather 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. Durstenfeld, Ivette F. Emery, Kristine M. Erlandson, Julio C. Facelli, Rachael Farah-Abraham, 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. Hauser, 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. Lamendola-Essel, Margaret Lanca, Joyce K. Lee-Lannotti, 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. Martin, Jeffrey N. Martin, Heidi T. May, Grace A. McComsey, Dylan McDonald, Hector Mendez-Figueroa, 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. Palomares, Tanyalak Parimon, Samuel Parry, Sairam Parthasarathy, Thomas F. Patterson, Ann Pearman, Michael J. Peluso, Priscilla Pemu, Christian M. Pettker, Beth A. Plunkett, Kristen Pogreba-Brown, Athena Poppas, J. Zachary Porterfield, 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. VanWagoner, 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

Laboratory Medicine and Pathology

Research output: Contribution to journal › Article › peer-review

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.

Original language	English (US)
Article number	e0286297
Journal	PloS one
Volume	18
Issue number	6 June
DOIs	https://doi.org/10.1371/journal.pone.0286297
State	Published - Jun 2023

ASJC Scopus subject areas

General

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10.1371/journal.pone.0286297

Cite this

Horwitz, L. I., Thaweethai, T., Brosnahan, S. B., Cicek, M. S., Fitzgerald, M. L., Goldman, J. D., Hess, R., Hodder, S. L., Jacoby, V. L., Jordan, M. R., Krishnan, J. A., Laiyemo, A. O., Metz, T. D., Nichols, L., Patzer, R. E., Sekar, A., Singer, N. G., Stiles, L. E., Taylor, B. S., ... Foulkes, A. S. (2023). Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design. PloS one, 18(6 June), Article e0286297. https://doi.org/10.1371/journal.pone.0286297

Horwitz, LI, Thaweethai, T, Brosnahan, SB, Cicek, MS, Fitzgerald, ML, Goldman, JD, Hess, R, Hodder, SL, Jacoby, VL, Jordan, MR, Krishnan, JA, Laiyemo, AO, Metz, TD, Nichols, L, Patzer, RE, Sekar, A, Singer, NG, Stiles, LE, Taylor, BS, Ahmed, S, Algren, HA, Anglin, K, Aponte-Soto, L, Ashktorab, H, Bassett, IV, Bedi, B, Bhadelia, N, Bime, C, Bind, MAC, Black, LJ, Blomkalns, AL, Brim, H, Castro, M, Chan, J, Charney, AW, Chen, BK, Chen, LQ, Chen, P, Chestek, D, Chibnik, LB, Chow, DC, Chu, HY, Clifton, RG, Collins, S, Costantine, MM, Cribbs, SK, Deeks, SG, Dickinson, JD, Donohue, SE, Durstenfeld, MS, Emery, IF, Erlandson, KM, Facelli, JC, Farah-Abraham, R, Finn, AV, Fischer, MS, Flaherman, VJ, Fleurimont, J, Fonseca, V, Gallagher, EJ, Gander, JC, Gennaro, ML, Gibson, KS, Go, M, Goodman, SN, Granger, JP, Greenway, FL, Hafner, JW, Han, JE, Harkins, MS, Hauser, KSP, Heath, JR, Hernandez, CR, Ho, O, Hoffman, MK, Hoover, SE, Horowitz, CR, Hsu, H, Hsue, PY, Hughes, BL, Jagannathan, P, James, JA, John, J, Jolley, S, Judd, SE, Juskowich, JJ, Kanjilal, DG, Karlson, EW, Katz, SD, Daniel Kelly, J, Kelly, SW, Kim, AY, Kirwan, JP, Knox, KS, Kumar, A, Lamendola-Essel, MF, Lanca, M, Lee-Lannotti, JK, Craig Lefebvre, R, Levy, BD, Lin, JY, Logarbo, BP, Logue, JK, Longo, MT, Luciano, CA, Lutrick, K, Malakooti, SK, Mallett, G, Maranga, G, Marathe, JG, Marconi, VC, Marshall, GD, Martin, CF, Martin, JN, May, HT, McComsey, GA, McDonald, D, Mendez-Figueroa, H, Miele, L, Mittleman, MA, Mohandas, S, Mouchati, C, Mullington, JM, Nadkarni, GN, Nahin, ER, Neuman, RB, Newman, LT, Nguyen, A, Nikolich, JZ, Ofotokun, I, Ogbogu, PU, Palatnik, A, Palomares, KTS, Parimon, T, Parry, S, Parthasarathy, S, Patterson, TF, Pearman, A, Peluso, MJ, Pemu, P, Pettker, CM, Plunkett, BA, Pogreba-Brown, K, Poppas, A, Zachary Porterfield, J, Quigley, JG, Quinn, DK, Raissy, H, Rebello, CJ, Reddy, UM, Reece, R, Reeder, HT, Rischard, FP, Rosas, JM, Rosen, CJ, Rouphael, NG, Rouse, DJ, Ruff, AM, Jean, CS, Sandoval, GJ, Santana, JL, Schlater, SM, Sciurba, FC, Selvaggi, C, Seshadri, S, Sesso, HD, Shah, DP, Shemesh, E, Sherif, ZA, Shinnick, DJ, Simhan, HN, Singh, U, Sowles, A, Subbian, V, Sun, J, Suthar, MS, Teunis, LJ, Thorp, JM, Ticotsky, A, Tita, ATN, Tragus, R, Tuttle, KR, Urdaneta, AE, Utz, PJ, VanWagoner, TM, Vasey, A, Vernon, SD, Vidal, C, Walker, T, Ward, HD, Warren, DE, Weeks, RM, Weiner, SJ, Weyer, JC, Wheeler, JL, Whiteheart, SW, Wiley, Z, Williams, NJ, Wisnivesky, JP, Wood, JC, Yee, LM, Young, NM, Zisis, SN & Foulkes, AS 2023, 'Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design', PloS one, vol. 18, no. 6 June, e0286297. https://doi.org/10.1371/journal.pone.0286297

@article{a242726772374db58a1458c706d16597,

title = "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.",

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

note = "Publisher Copyright: Copyright: {\textcopyright} 2023 Horwitz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",

year = "2023",

month = jun,

doi = "10.1371/journal.pone.0286297",

language = "English (US)",

volume = "18",

journal = "PloS one",

issn = "1932-6203",

publisher = "Public Library of Science",

number = "6 June",

}

TY - JOUR

T1 - Researching COVID to Enhance Recovery (RECOVER) adult study protocol

T2 - Rationale, objectives, and design

AU - Horwitz, Leora I.

AU - Thaweethai, Tanayott

AU - Brosnahan, Shari B.

AU - Cicek, Mine S.

AU - Fitzgerald, Megan L.

AU - Goldman, Jason D.

AU - Hess, Rachel

AU - Hodder, S. L.

AU - Jacoby, Vanessa L.

AU - Jordan, Michael R.

AU - Krishnan, Jerry A.

AU - Laiyemo, Adeyinka O.

AU - Metz, Torri D.

AU - Nichols, Lauren

AU - Patzer, Rachel E.

AU - Sekar, Anisha

AU - Singer, Nora G.

AU - Stiles, Lauren E.

AU - Taylor, Barbara S.

AU - Ahmed, Shifa

AU - Algren, Heather A.

AU - Anglin, Khamal

AU - Aponte-Soto, Lisa

AU - Ashktorab, Hassan

AU - Bassett, Ingrid V.

AU - Bedi, Brahmchetna

AU - Bhadelia, Nahid

AU - Bime, Christian

AU - Bind, Marie Abele C.

AU - Black, Lora J.

AU - Blomkalns, Andra L.

AU - Brim, Hassan

AU - Castro, Mario

AU - Chan, James

AU - Charney, Alexander W.

AU - Chen, Benjamin K.

AU - Chen, Li Qing

AU - Chen, Peter

AU - Chestek, David

AU - Chibnik, Lori B.

AU - Chow, Dominic C.

AU - Chu, Helen Y.

AU - Clifton, Rebecca G.

AU - Collins, Shelby

AU - Costantine, Maged M.

AU - Cribbs, Sushma K.

AU - Deeks, Steven G.

AU - Dickinson, John D.

AU - Donohue, Sarah E.

AU - Durstenfeld, Matthew S.

AU - Emery, Ivette F.

AU - Erlandson, Kristine M.

AU - Facelli, Julio C.

AU - Farah-Abraham, Rachael

AU - Finn, Aloke V.

AU - Fischer, Melinda S.

AU - Flaherman, Valerie J.

AU - Fleurimont, Judes

AU - Fonseca, Vivian

AU - Gallagher, Emily J.

AU - Gander, Jennifer C.

AU - Gennaro, Maria Laura

AU - Gibson, Kelly S.

AU - Go, Minjoung

AU - Goodman, Steven N.

AU - Granger, Joey P.

AU - Greenway, Frank L.

AU - Hafner, John W.

AU - Han, Jenny E.

AU - Harkins, Michelle S.

AU - Hauser, Kristine S.P.

AU - Heath, James R.

AU - Hernandez, Carla R.

AU - Ho, On

AU - Hoffman, Matthew K.

AU - Hoover, Susan E.

AU - Horowitz, Carol R.

AU - Hsu, Harvey

AU - Hsue, Priscilla Y.

AU - Hughes, Brenna L.

AU - Jagannathan, Prasanna

AU - James, Judith A.

AU - John, Janice

AU - Jolley, Sarah

AU - Judd, S. E.

AU - Juskowich, Joy J.

AU - Kanjilal, Diane G.

AU - Karlson, Elizabeth W.

AU - Katz, Stuart D.

AU - Daniel Kelly, J.

AU - Kelly, Sara W.

AU - Kim, Arthur Y.

AU - Kirwan, John P.

AU - Knox, Kenneth S.

AU - Kumar, Andre

AU - Lamendola-Essel, Michelle F.

AU - Lanca, Margaret

AU - Lee-Lannotti, Joyce K.

AU - Craig Lefebvre, R.

AU - Levy, Bruce D.

AU - Lin, Janet Y.

AU - Logarbo, Brian P.

AU - Logue, Jennifer K.

AU - Longo, Michele T.

AU - Luciano, Carlos A.

AU - Lutrick, Karen

AU - Malakooti, Shahdi K.

AU - Mallett, Gail

AU - Maranga, Gabrielle

AU - Marathe, Jai G.

AU - Marconi, Vincent C.

AU - Marshall, Gailen D.

AU - Martin, Christopher F.

AU - Martin, Jeffrey N.

AU - May, Heidi T.

AU - McComsey, Grace A.

AU - McDonald, Dylan

AU - Mendez-Figueroa, Hector

AU - Miele, Lucio

AU - Mittleman, Murray A.

AU - Mohandas, Sindhu

AU - Mouchati, Christian

AU - Mullington, Janet M.

AU - Nadkarni, Girish N.

AU - Nahin, Erica R.

AU - Neuman, Robert B.

AU - Newman, Lisa T.

AU - Nguyen, Amber

AU - Nikolich, Janko Z.

AU - Ofotokun, Igho

AU - Ogbogu, Princess U.

AU - Palatnik, Anna

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N1 - Publisher Copyright: Copyright: © 2023 Horwitz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PY - 2023/6

Y1 - 2023/6

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85162785936&partnerID=8YFLogxK

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U2 - 10.1371/journal.pone.0286297

DO - 10.1371/journal.pone.0286297

M3 - Article

C2 - 37352211

AN - SCOPUS:85162785936

SN - 1932-6203

VL - 18

JO - PloS one

JF - PloS one

IS - 6 June

M1 - e0286297

ER -

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

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