NIH RECOVER: A Multi-Site Pathology Study of Post-Acute Sequelae of SARS-CoV-2 Infection

The RECOVER tissue pathology study is a cross-sectional study designed to define and characterize the epidemiology, natural history, clinical spectrum, and underlying mechanisms of post-acute effects of SARS-CoV-2 infection in a diverse population representative of the general COVID-19 population in the US. The autopsy study will characterize the pathology of PASC in decedents who die more than 60 days after initial onset or after hospital discharge, whether in-hospital or out-of-hospital at time of death, and who meet the working definition of PASC as defined by the recent World Health Organization publication given in Section 5.4. The autopsy study will also explore the pathology of acute SARS-CoV-2 infection in a smaller subset of decedents who died between15-60 days from symptom onset. This protocol defines the common set of clinical data elements, autopsy procedures for tissue collection, core measures, pathology protocols, shared pathology tissues, data elements, and methodology. Each investigator site is expected to perform autopsies on the decedents to address the pathophysiology of the potential long-term effects of SARS-CoV-2 infection on human health. The Consortium analysis plan aims to address research questions by incorporating: 1) tissue obtained from autopsies performed at each Phase II participant's site; and 2) tissue available from other pathology investigators/autopsy sites within the Consortium.]]>
Release Notes for RECOVER Tissue Pathology StudyRECOVER Autopsy CodebookInclusion Criteria:Decedents over the age of 18 years at the time of death will be eligible for inclusion. Infected individuals will have suspected, probable, or confirmed SARS-CoV-2 infection as defined by WHO criteria, within 24 months of enrollment. Patients with suspected SARS-CoV-2 infection Patients who meet the clinical and epidemiological criteria listed below.Clinical Criteria:Acute onset of fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, anorexia/nausea/vomiting, diarrhea, altered mental statusEpidemiological Criteria: Having resided or worked in an area with a high risk of transmission of virus: closed residential, school, or camp settings any time within the 14 days before symptom onset; orHaving resided or traveled to an area with community transmission any time within the 14 days before symptom onset; orAny known household contact or any member of the household working in any health care setting, including within health facilities or within the community, any time within the 14 days before symptom onsetAn asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.Patients with Probable SARS-CoV-2 Infection:A patient who meets clinical criteria above AND is a contact of a probable or confirmed case or linked to a COVID-19 cluster; or A suspected case with chest imaging showing findings suggestive of COVID-19 disease; or A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause; or Death, not otherwise explained, in an adult with respiratory distress preceding death AND who was a contact of a probable or confirmed case or linked to a COVID-19 cluster.Patients with Confirmed SARS-CoV-2 Infection:A person with a positive Nucleic Acid Amplification Test (NAAT); or A person with a positive SARS-CoV-2 Antigen-RDT AND meeting either the probable case definition or suspected criteria a) or b); or An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who was a contact of a probable or confirmed case. General Eligibility Notes:Decedents with or without history of MIS-A or MIS-C are eligible; Decedents with or without history of SARS-CoV-2 vaccination are eligible; Decedents with recurrent SARS-CoV-2 infections and those with post-vaccination (breakthrough) infections are eligible; Decedents are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions. Exclusion Criteria:Decedents under the age of 18 at the time of death Decedents dying within 14 days of their initial SARS-CoV-2 infection Decedents in whom the postmortem interval (PMI) is greater than 24 hours Decedents with any indications of criminal investigation at time of death Decedents with signs of decomposition and trauma]]>