RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-08
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05292274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients who meet the clinical and epidemiological criteria listed below:
  2. 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
  3. 2. Having resided or traveled to an area with community transmission any time within the 14 days before symptom onset; or
  4. 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.
  5. 2. An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.
  6. 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
  7. 2. A suspected case with chest imaging showing findings suggestive of COVID-19 disease; or
  8. 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
  9. 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.
  10. 1. A person with a positive Nucleic Acid Amplification Test (NAAT); or
  11. 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
  12. 3. An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who was a contact of a probable or confirmed case.
  13. 1. Decedents with or without history of MIS-A or MIS-C are eligible;
  14. 2. Decedents with or without history of SARS-CoV-2 vaccination are eligible;
  15. 3. Decedents with recurrent SARS-CoV-2 infections and those with post-vaccination (breakthrough) infections are eligible;
  16. 4. Decedents are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Phoebe Del Boccio, PhD
CONTACT
646-987-1266
Phoebe.Delboccio@nyulangone.org
Andrea Troxel, ScD
CONTACT
646-501-3654
Andrea.Troxel@nyulangone.org

Principal Investigator

Stuart Katz, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health
Leora Horwitz, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health
Andrea Troxel, ScD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Stuart Katz, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health
  • Leora Horwitz, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health
  • Andrea Troxel, ScD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-08
Study Completion Date2026-02

Study Record Updates

Study Start Date2022-03-08
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • COVID-19
  • SARS CoV 2 Infection