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Can our genes and gut explain long COVID?

NCT ID NCT07757620

Knowledge-focused Sponsor: Istituti Clinici Scientifici Maugeri SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This observational study aims to uncover the biological mechanisms behind long COVID by comparing adults with long COVID, those who fully recovered from COVID-19, and healthy controls. Researchers will analyze blood and, when available, intestinal tissue to examine gene activity, DNA methylation, immune cell profiles, and gut microbiome composition. The goal is to identify molecular biomarkers that could improve diagnosis, patient stratification, and future precision medicine approaches for long COVID.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could identify biomarkers for diagnosing long COVID and point toward new treatments targeting the gut-immune axis.
What could go wrong
As an observational study, it cannot prove cause and effect. Findings may not translate into therapies, and the complexity of long COVID may limit generalizability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Post COVID-19 patients: Retrospective population of patients that manifested COVID-19 and recovered without sequelae. Long COVID-19 patients: Retrospective and prospective populations of patients that manifested COVID-19 and developed sequelae. The retrospective cohort includes subjects with long COVID-19 with or without cardio-pulmonary symptoms. The prospective cohort includes patients with long COVID-19 and gastrointestinal symptoms. Control Group: Retrospective population of subjects who never had SARS-CoV-2 infection.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 long COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Long COVID symptoms Long COVID-19 syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istituti Clinici Scientifici Maugeri

    Pavia, 27100, Italy

  • Istituto Auxologico Italiano

    Cusano Milanino, Milano, 20095, Italy

  • Ospedale San Raffaele S.r.l.

    Milan, 20132, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.