NIH RECOVER Tissue Pathology: Understanding the Long-Term Impact of COVID-19

NCT05292274 | Recruiting DMC

• 1 other identifier: RECOVER-Path
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The Post-Acute Sequelae of SARS-CoV-2 (PASC) Autopsy 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 (i) non-hospitalized patients who die 30 days or later from symptom onset of COVID-19, and (ii) hospitalized patients who die 30 days or later after discharge from a hospitalization for COVID-19. The study will include decedents who had previously fully recovered from SARS-CoV-2 infection (i.e., \>30 days from onset in non-hospitalized, or \>30 days from discharge in hospitalized patients), and decedents who meet clinical criteria of PASC as defined by the recent World Health Organization publication (see Section 5.4 below). The autopsy study will also explore the pathology of acute SARS-CoV-2 infection in a smaller subset of patients who died 15-30 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.

Conditions

COVID-19; SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (4)

• Number of decedents with presence of inflammation

  In decedents with acute SARS-CoV-2 infection (dying 15-30 days after infection), and in decedents with prior SARS-CoV-2 infection (who die more than 30 days after initial onset, in-hospital and out-of-hospital) with and without PASC.

  Month 24

• Number of decedents with presence of fibrosis

  In decedents with acute SARS-CoV-2 infection (dying 15-30 days after infection), and in decedents with prior SARS-CoV-2 infection (who die more than 30 days after initial onset, in-hospital and out-of-hospital) with and without PASC.

  Month 24

• Number of decedents with presence of thrombosis

  n decedents with acute SARS-CoV-2 infection (dying 15-30 days after infection), and in decedents with prior SARS-CoV-2 infection (who die more than 30 days after initial onset, in-hospital and out-of-hospital) with and without PASC.

  Month 24

• Number of decedents with presence of necrosis

  In decedents with acute SARS-CoV-2 infection (dying 15-30 days after infection), and in decedents with prior SARS-CoV-2 infection (who die more than 30 days after initial onset, in-hospital and out-of-hospital) with and without PASC.

  Month 24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. Next of kin will provide consent in accordance with local legal requirements to participate in autopsy and biological sample collection as specified in the protocol procedures.

You may qualify if:

• Patients with suspected SARS-CoV-2 infection
• Patients who meet the clinical and epidemiological criteria listed below:
• Clinical criteria: Acute onset of fever and cough or acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, anorexia/nausea/vomiting, diarrhea, altered mental status.
• Epidemiological 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; or
• Having resided or traveled to an area with community transmission any time within the 14 days before symptom onset; or
• Any 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 onset.
• An 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, body fluids, snap frozen and formalin-fixed tissue samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stuart Katz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Leora Horwitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Andrea Troxel, ScD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phoebe Del Boccio, PhD

CONTACT

646-987-1266; Phoebe.Delboccio@nyulangone.org

Andrea Troxel, ScD

CONTACT

646-501-3654; Andrea.Troxel@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 23, 2022
• Study Start: March 8, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 months and with no end date. Data products from this study will be made available to researchers and analysts through the PASC Consortium Data Resource Core.
• Access Criteria: The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to RECOVER\ CSC@NYULangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)