Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Recruiting Locations

NYU Langone Health
New York, New York 10016

More Details

NCT ID
NCT05292274
Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.