NIH RECOVER Tissue Pathology: Understanding the Long-Term Impact of COVID-19 (NCT05292274) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
NIH RECOVER Tissue Pathology: Understanding the Long-Term Impact of COVID-19
United States304 participantsStarted 2022-03-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who meet the clinical and epidemiological criteria listed below:
. 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
. Having resided or traveled to an area with community transmission any time within the 14 days before symptom onset; or
. 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.
. An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on examining tissue from deceased patients to understand how COVID-19 affects organs long-term, it's not a treatment trial — so how might the findings from studies like this one actually change the care I receive for my Long COVID or post-COVID symptoms?
2This trial is listed as 'active, not recruiting,' meaning they're no longer enrolling participants — does that mean there are other RECOVER program studies still open that might be more directly relevant to my situation?
3The study is looking at things like inflammation, fibrosis, and blood clotting in tissues after COVID-19 — based on what researchers are finding, are there any of these changes my doctor is concerned about in my own case that we should be monitoring or testing for?
4Since this is a tissue pathology study rather than a treatment trial, and it has no assigned phase, what practical steps can my care team take right now based on what's already known about COVID-19's long-term effects on organs, while we wait for more research like this to be published?
5If this study is helping scientists understand why some people develop serious long-term organ damage after COVID-19, are there any early warning signs or symptoms I should watch for that would prompt my doctor to investigate whether something like fibrosis or chronic inflammation might be happening in my body?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.