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

Andrea B. Troxel, Marie Abele C. Bind, Thomas J. Flotte, Carlos Cordon-Cardo, Lauren A. Decker, Aloke V. Finn, Robert F. Padera, R. Ross Reichard, James R. Stone, Natalie L. Adolphi, Faye Victoria C. Casimero, John F. Crary, Jamie Elifritz, Arline Faustin, Saikat Kumar B. Ghosh, Amanda Krausert, Maria Martinez-Lage, Jonathan Melamed, Roger A. Mitchell, Barbara A. SampsonAlan C. Seifert, Aylin Simsir, Cheryle Adams, Stephanie Haasnoot, Stephanie Hafner, Michelle A. Siciliano, Brittany B. Vallejos, Phoebe Del Boccio, Michelle F. Lamendola-Essel, Chloe E. Young, Deepshikha Kewlani, Precious A. Akinbo, Brendan Parent, Alicia Chung, Teresa C. Cato, Praveen C. Mudumbi, Shari Esquenazi-Karonika, Marion J. Wood, James Chan, Jonathan Monteiro, Daniel J. Shinnick, Tanayott Thaweethai, Amber N. Nguyen, Megan L. Fitzgerald, Alice A. Perlowski, Lauren E. Stiles, Moira L. Paskett, Stuart D. Katz, Andrea S. Foulkes, Preciosa Akinbo, Phoebe Del Boccio, Michelle Lamendola-Essel, Chloe Young, Faye Victoria C. Casimero, Maria Martinez Lage Alvarez, Robert F. Padera, Michelle Siciliano, Aloke Virmani Finn, Katie Burack, Ashley DeGrange, Youraline Joseph, Rika Kawakami, Robert Kutys, Tina Richards, Maria Romero, Torie Samuda, Renu Virmani, Cheryle Adams, Hassan Brim, La Tenzar Everrett, Devon Jackson, Mary Bruno, Ezeddin Fadel, Camila Fang, Arline Faustin, Estefania Gallego, Eduardo Iturrate, Deepshikha Kewlani, Jan Osea, Timothy Shepherd, Michael Harris, Melissa Klein, Matthew LoMastro, Moira Paskett, Stephanie Hafner, Lisa Hines, Kejal Kantarci, Claudia Lucinetti, Joseph Maleszewski, Teresa Moran, Kristina Peters, Katelyn Reed, Emily Scharrer, Nicole Steinle, Suzanne Taylor, Luke Wilson, Thor Wirth, Thomas Flotte, Mary Beth Beasley, Kristin Beaumont, Michael Beaumont, Rachel Brody, Alessandra Cervera, Alexander Charney, John Crary, Kristen Dams-O’Connor, Siraj El Jamal, Rebecca Folkerth, Andrea Gonzalez, Ronald Gordon, Sabina Guliyeva, Stephanie Haasnoot, Kenneth Haines, Nathalie Jette, Amanda Krausert, Bea Martin, Russell McBride, Alberto Mondolfi, Susan Morgello, Elisabet Pujadas, Barbara Sampson, Robert Sebra, Alan Seifert, Aryeh Stock, Aleeka Wade, Emma Woodoff Leith, Paula Yarbrough, Natalie Adolphi, Stacy Catanach, Lauren Decker, Jamie Elifritz, Hadya Khawaja, Jacob Ormsby, Kyla Sorensen, Brittany Vallejos, Claire Wells

Research output: Contribution to journalArticlepeer-review

Abstract

Importance SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or organ dysfunction after the acute phase of infection, termed Post-Acute Sequelae of SARS-CoV-2 (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are poorly understood. The objectives of the Researching COVID to Enhance Recovery (RECOVER) tissue pathology study (RECOVER-Pathology) are to: (1) characterize prevalence and types of organ injury/disease and pathology occurring with PASC; (2) characterize the association of pathologic findings with clinical and other characteristics; (3) define the pathophysiology and mechanisms of PASC, and possible mediation via viral persistence; and (4) establish a post-mortem tissue biobank and post-mortem brain imaging biorepository. Methods RECOVER-Pathology is a cross-sectional study of decedents dying at least 15 days following initial SARS-CoV-2 infection. Eligible decedents must meet WHO criteria for suspected, probable, or confirmed infection and must be aged 18 years or more at the time of death. Enrollment occurs at 7 sites in four U.S. states and Washington, DC. Comprehensive autopsies are conducted according to a standardized protocol within 24 hours of death; tissue samples are sent to the PASC Biorepository for later analyses. Data on clinical history are collected from the medical records and/or next of kin. The primary study outcomes include an array of pathologic features organized by organ system. Causal inference methods will be employed to investigate associations between risk factors and pathologic outcomes. Discussion RECOVER-Pathology is the largest autopsy study addressing PASC among US adults. Results of this study are intended to elucidate mechanisms of organ injury and disease and enhance our understanding of the pathophysiology of PASC.

Original languageEnglish (US)
Article numbere0285645
JournalPloS one
Volume19
Issue number1 January
DOIs
StatePublished - Jan 2024

ASJC Scopus subject areas

  • General

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