| NCT ID | NCT06825819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | COVID-19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-01-21 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The SARS-CoV-2 virus causes COVID-19, which ranges from mild initial symptoms to severe multi-organ dysfunction. While some patients recover to their baseline states, others develop a long COVID, or post-acute sequelae of SARS-CoV-2 (PASC) consisting of symptoms persisting \>2-6 months post-infection. PASC symptoms include post-exertional malaise, fatigue, and heart palpitations as well as incident GI disorders, cognitive dysfunction, and arthritis. Based on prevalence/incidence studies, it is estimated that more than 30 million people in the US have ever developed PASC with 10-11% of patients or 11 million people continuing to feel symptoms to the present day10. SARS-CoV-2 vaccines are only \~32% effective against infection at 4 months post-vaccination11, only 15% effective against the development of PASC12, and only 20% of American adults have received an updated booster as of December 202313. It is therefore imperative that the scientific community make progress in identifying underlying causes of PASC to develop effective treatments. This study will identify microbial metabolites associated with PASC-mediated gut dysbiosis and establish a tractable in vitro model to test T cell-gut epithelium dynamics to develop novel bio-therapeutics for multiple post-viral conditions. This case-control study will collect biospecimens (matched stool \& blood) samples from 400 people with and without long COVID (200 participants/group) to understand how COVID-induced dysbiosis impacts symptom severity, immune suppression, and gut barrier dysfunction both ex vivo and in vitro.
Eligibility Criteria
Inclusion Criteria: * Age: 18-80 * Sex: Any * Race: Any * Last COVID infection: within past 3 years, PCR- or antigen-confirmed, symptomatic (mild/moderate/severe) * COVID vaccination status: Any * Presence of long COVID symptoms (GI, cardiac, pulmonary, neuro, musculoskeletal, and/or psych): 200 with symptoms, 200 w/o symptoms as defined by SBQ-LCTM. * May or may not be doing routine endoscopy at UCM Exclusion Criteria: * Age \<18 or \>80 * Last COVID infection \>3 years ago (PCR/antigen-confirmed, symptomatic) * Currently or within the last 3 months COVID+ by nasopharyngeal PCR/antigen test * Currently diagnosed with cancer * Currently pregnant (cannot take colon biopsy sample; only eligible for survey/blood \& stool collection) * Currently on biologic immunomodulatory medications * Official diagnosis of irritable bowel disease (IBD) or other chronic GI disorder Vulnerable and/or Special Populations * Healthy adult volunteers * Pregnant people * UCMC and UChicago employees * Staff/faculty
Contact & Investigator
Lavanya Visvabharathy, Ph.D
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06825819 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06825819 currently recruiting?
Yes, NCT06825819 is actively recruiting participants. Contact the research team at lavanya.visvabharathy@bsd.uchicago.edu for enrollment information.
Where is the NCT06825819 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06825819 clinical trial?
NCT06825819 is sponsored by University of Chicago. The principal investigator is Lavanya Visvabharathy, Ph.D at University of Chicago. The trial plans to enroll 400 participants.
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