Understanding the long-term effects of COVID-19 through autopsy analysis
NIH RECOVER: A Multi-site Pathology Study of Post-Acute Sequelae of SARS-CoV-2 Infection
This study looks at the long-term effects of COVID-19 by examining the bodies of people who died after recovering from the virus to see what caused their health problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05292274 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term impacts of COVID-19 by conducting autopsies on individuals who have died after recovering from SARS-CoV-2 infection. It will focus on both non-hospitalized patients who die more than 30 days after symptom onset and hospitalized patients who die more than 30 days after discharge. The study seeks to characterize the pathology associated with post-acute sequelae of SARS-CoV-2 infection (PASC) and explore the underlying mechanisms of these long-term effects in a diverse population across the United States.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced symptoms of COVID-19 and have died more than 30 days after symptom onset or discharge from hospitalization.
Not a fit: Patients who have not been infected with SARS-CoV-2 or who have died within 30 days of symptom onset or hospitalization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the long-term health consequences of COVID-19, potentially guiding future treatment and management strategies.
How similar studies have performed: Other studies examining the long-term effects of COVID-19 have shown promising results, indicating that this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Stuart Katz, MD — NYU Langone Health
- Study coordinator: Phoebe Del Boccio, PhD
- Email: Phoebe.Delboccio@nyulangone.org
- Phone: 646-987-1266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.