COVID-19NCT05292274
NIH RECOVER Tissue Pathology: Understanding the Long-Term Impact of COVID-19
An observational study of COVID-19 and SARS CoV 2 Infection, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS CoV 2 Infection
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NIH RECOVER: A Multi-site Pathology Study of Post-Acute Sequelae of SARS-CoV-2 Infection
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
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start30 Mar 2022
- Primary completion30 Jan 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Katz, MD, Principal investigator, NYU Langone HealthLeora Horwitz, MD, Principal investigator, NYU Langone HealthAndrea Troxel, ScD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292274
- Sponsor's protocol ID
- RECOVER-Path
- Status last verified
- May 2026
- First submitted
- 22 Mar 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIH RECOVER: A Multi-site Pathology Study of Post-Acute Sequelae of SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT05292274
- Acronym / sponsor ID
- RECOVER-Path
- Conditions
- COVID-19, SARS CoV 2 Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- 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.
- An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.
- Patients with probable SARS-CoV-2 infection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of decedents with presence of inflammation
Time frame: Month 24
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.
Number of decedents with presence of fibrosis
Time frame: Month 24
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.
Number of decedents with presence of thrombosis
Time frame: Month 24
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.
Number of decedents with presence of necrosis
Time frame: Month 24
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Katz, MD principal investigator
NYU Langone Health
Leora Horwitz, MD principal investigator
NYU Langone Health
Andrea Troxel, ScD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS CoV 2 Infection, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of decedents with presence of inflammation (time frame: Month 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.