NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Epigenetic Changes in Long COVID Patients

Not Yet RecruitingN/A

Sponsor: Istituti Clinici Scientifici Maugeri SpA

Conditions: Long COVID-19 Syndrome, Long COVID Symptoms

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria (Post COVID-19 patients):

* 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.

Inclusion Criteria (Long COVID-19 patients):

* 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.

Inclusion Criteria (Control Group):

* 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.

Exclusion Criteria:

* Inability to provide informed consent.
* Presence of severe systemic autoimmune diseases or congenital/acquired immunodeficiencies that may confound the interpretation of immunological data.
* Current systemic immunosuppressive therapy or treatment within the last 6 months prior to enrollment.
* Active malignancies or those treated within the last 12 months (except basal or squamous cell carcinomas in situ).
* Pregnancy or breastfeeding at the time of enrollment.
* Any other clinical condition that, in the investigator's opinion, could compromise the reliability of the data collected.

Locations (3)

Cusano Milanino, Milano, Italy
Milan, Italy
Pavia, Italy