NCT07757620Active, not recruiting
Epigenetic Changes in Long COVID Patients
Epigenetic Changes in Long COVID Patients: Unraveling the Gut-Immune Axis and Therapeutic Targets
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The goal of this observational study is to improve the understanding of the biological mechanisms underlying long COVID and to identify molecular biomarkers that may support its diagnosis, prognosis, and future precision medicine approaches in adults with long COVID, adults who have fully recovered from COVID-19, and healthy control participants. The main questions it aims to answer are: * What molecular, immunological, epigenetic, and microbiome profiles distinguish individuals with long COVID from recovered COVID-19 participants and healthy controls? * How are viral persistence, immune dysregulation, and alterations in the gut-immune axis associated with the development and clinical manifestations of long COVID? * Which molecular biomarkers may improve disease diagnosis, patient stratification, and the identification of potential therapeutic targets? Participants will: * Undergo clinical evaluation and provide information about their medical history and symptoms. * Provide biological samples, including blood and, when clinically indicated, intestinal biopsy tissue collected during routine colonoscopy procedures. * Undergo comprehensive molecular analyses, including immunological, epigenetic, transcriptomic, proteomic, and microbiome profiling. * Have their clinical and molecular data integrated using advanced computational approaches to identify biological signatures associated with long COVID. The results of this study may improve the understanding of the biological mechanisms underlying long COVID and support the development of novel biomarkers and future precision medicine approaches for diagnosis, prognosis, patient stratification, and therapeutic target identification.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 12 Oct 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT07757620
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 12 Oct 2026 to the primary completion date, Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current systemic immunosuppressive therapy or treatment within the last 6 months prior to enrollment.
Other illness
- Presence of severe systemic autoimmune diseases or congenital/acquired immunodeficiencies that may confound the interpretation of immunological data.
- Active malignancies or those treated within the last 12 months (except basal or squamous cell carcinomas in situ).
- Any other clinical condition that, in the investigator's opinion, could compromise the reliability of the data collected.
Other
- Inability to provide informed consent.
- Pregnancy or breastfeeding at the time of enrollment.
Who the study is looking for
- Age ≥ 18 years.
- Previous SARS-CoV-2 infection documented by molecular or serological testing.
- Absence of persistent symptoms 2 months after acute infection.
- Willingness to provide written informed consent.
- Age ≥ 18 years.
- Previous SARS-CoV-2 infection documented by molecular or serological testing.
- Persistent symptoms at least 2 months after acute infection, according to the WHO definition of long COVID \[https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition\].
- Willingness to provide written informed consent.
- Age ≥ 18 years.
- No previous SARS-CoV-2 infection (documented by serology).
- Blood sample collected according to the COVID-BioVac protocol (NCT05276388) before the first administration of the SARS-CoV-2 vaccine.
- Willingness to provide written informed consent.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Cusano Milanino | Italy | Unknown status |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.