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Active, not recruitingNCT05292274Updated May 29, 2026

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

An observational study in COVID-19 and SARS CoV 2 Infection, sponsored by NYU Langone Health. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
304
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19
  • SARS CoV 2 Infection

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 304 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

Inclusion Criteria:

Patients with suspected SARS-CoV-2 infection

  1. 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:

    1. 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
    2. Having resided or traveled to an area with community transmission any time within the 14 days before symptom onset; or
    3. 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.
  2. An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.

Patients with probable SARS-CoV-2 infection

  1. 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
  2. A suspected case with chest imaging showing findings suggestive of COVID-19 disease; or
  3. A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause; or
  4. 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

  1. A person with a positive Nucleic Acid Amplification Test (NAAT); or
  2. A person with a positive SARS-CoV-2 Antigen-RDT AND meeting either the probable case definition or suspected criteria a) or b); or
  3. An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who was a contact of a probable or confirmed case.

General Eligibility Notes:

  1. Decedents with or without history of MIS-A or MIS-C are eligible;
  2. Decedents with or without history of SARS-CoV-2 vaccination are eligible;
  3. Decedents with recurrent SARS-CoV-2 infections and those with post-vaccination (breakthrough) infections are eligible;
  4. Decedents are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
304 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Month 24

  2. 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.

    Time frame: Month 24

  3. 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.

    Time frame: Month 24

  4. 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.

    Time frame: Month 24

07

Study locations

1 site
  • NYU Langone Health
    New York, New York 10016, United States
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05292274
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Mar 23, 2022
Start date
Mar 30, 2022
Primary completion
Jan 30, 2026
Completion
Mar 31, 2027 (estimated)
Last update
May 29, 2026

Study contacts

Stuart Katz, MD
principal investigator · NYU Langone Health
Leora Horwitz, MD
principal investigator · NYU Langone Health
Andrea Troxel, ScD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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