Researching COVID to enhance recovery (RECOVER) tissue pathology study protocol: Rationale, objectives, and design
Troxel, AB; Bind, MC; Flotte, TJ; et al., PLOS One, January 2024
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Short Summary
A COVID-19 infection can lead to new symptoms, or symptoms that do not go away. This condition is called Long COVID. RECOVER researchers are using tissue samples from people who died after having COVID to answer questions about Long COVID. To do this, they are studying donated samples from deceased people across the US to understand how the body changes when someone has Long COVID; what makes some people more likely to develop Long COVID, such as where a person lives and their age, race, and sex; and what happens in the body of someone who had Long COVID. This paper is important because it can show other scientists how to do their own research on Long COVID in people who have died.
This summary was prepared by the RECOVER Initiative.
Publication Details
DOI: 10.1371/journal.pone.0285645
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.
Authors
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 Sampson, Alan 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, RECOVER Initiative Autopsy Group
Keywords
Adult; Humans; COVID-19; SARS-CoV-2; Cross-Sectional Studies; Post-Acute COVID-19 Syndrome; Disease Progression; Risk Factors