Official Title
NIH RECOVER: A Multi-site Pathology Study of Post-Acute Sequelae of SARS-CoV-2 Infection
Brief Summary

The Post-Acute Sequelae of SARS-CoV-2 (PASC) Autopsy Study is a cross-sectional studydesigned to define and characterize the epidemiology, natural history, clinical spectrum,and underlying mechanisms of post-acute effects of SARS-CoV-2 infection in a diversepopulation representative of the general COVID-19 population in the US. The autopsy studywill characterize the pathology of PASC in (i) non-hospitalized patients who die 30 daysor later from symptom onset of COVID-19, and (ii) hospitalized patients who die 30 daysor later after discharge from a hospitalization for COVID-19. The study will includedecedents who had previously fully recovered from SARS-CoV-2 infection (i.e., >30 daysfrom onset in non-hospitalized, or >30 days from discharge in hospitalized patients), anddecedents who meet clinical criteria of PASC as defined by the recent World HealthOrganization publication (see Section 5.4 below). The autopsy study will also explore thepathology of acute SARS-CoV-2 infection in a smaller subset of patients who died 15-30days from symptom onset. This protocol defines the common set of clinical data elements,autopsy procedures for tissue collection, core measures, pathology protocols, sharedpathology tissues, data elements, and methodology. Each investigator site is expected toperform autopsies on the decedents to address the pathophysiology of the potentiallong-term effects of SARS-CoV-2 infection on human health. The Consortium analysis planaims to address research questions by incorporating: 1) tissue obtained from autopsiesperformed at each Phase II participant's site; and 2) tissue available from otherpathology investigators/autopsy sites within the Consortium.

Detailed Description

Not Provided

Recruiting
COVID-19
SARS CoV 2 Infection
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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

NYU Langone Health
New York, New York, United States

Investigator: Stuart Katz, MD

Contacts

Phoebe Del Boccio, PhD
646-987-1266
Phoebe.Delboccio@nyulangone.org

Andrea Troxel, ScD
646-501-3654
Andrea.Troxel@nyulangone.org

NYU Langone Health
NCT Number
MeSH Terms
Infections
COVID-19