Clinical trial NCT05292274: NIH RECOVER Tissue Pathology: Understanding the Long-Term Impact of COVID-19
Official title: NIH RECOVER: A Multi-site Pathology Study of Post-Acute Sequelae of SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
SARS CoV 2 Infection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Number of decedents with presence of inflammation
timeFrame: Month 24
measure: Number of decedents with presence of fibrosis
timeFrame: Month 24
measure: Number of decedents with presence of thrombosis
timeFrame: Month 24
measure: Number of decedents with presence of necrosis
timeFrame: Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stuart Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Leora Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Andrea Troxel, ScD
role: PRINCIPAL_INVESTIGATOR
References: