About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
IRCCS Ospedale San Raffaele
Collaborator
Istituto Auxologico Italiano
Collaborator