Biomarkers of LONG COVID (LONG COVID_LCM) (LONG COVID_LCM)

May 7, 2025 updated by: Fabio Martelli, IRCCS Policlinico S. Donato

Study of Innovative Biomarkers of Systemic Inflammation in LONG COVID Patients

This observational prospective study is aimed to investigate noncoding RNAs (ncRNAs) such as microRNAs (miRNAs) and long noncoding RNAs (lncRNAs) as potential peripheral blood biomarkers of severity and poor prognosis in COVID-19 patients. Patients with intermittent or permanent symptoms after COVID-19 at the moment of the recruitment were considered affected by LONG COVID disease. In particular, the aim is to clarify if COVID-19 biomarkers remain deregulated similarly in LONG COVID patients. To this purpose, plasma and peripheral blood mononuclear cells (PBMCs) will be collected and patients will be compared to individuals who have never been affected by COVID-19 or asymptomatic LONG COVID patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will collect plasma and PBMCs from consenting subjects. The investigators will evaluate the expression of miRNAs, lncRNAs and cytokines in patients affected by LONG COVID admitted to IRCCS Policlinico San Donato during the acute phase of COVID-19. In particular, miRNAs will be evaluated in plasma samples while lncRNAs in PBMC samples to clarify their potential as biomarkers.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • San Donato Milanese, Milan, Italy, 20097
        • IRCCS Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients admitted to IRCCS Policlinico San Donato during the acute phase of COVID-19

Description

Inclusion Criteria:

  • Previous COVID-19 infection

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LONG COVID patients
Measurement of ncRNAs and cytokines in patients with new diseases or intermittent or permanent symptoms after COVID-19 at the moment of the recruitment
Diagnostic test: Measurement of ncRNAs and cytokines
Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.
Controls
Measurement of ncRNAs and cytokines in Individuals who have never suffered from COVID-19 at the moment of the recruitment
Diagnostic test: Measurement of ncRNAs and cytokines
Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.
Asymptomatic LONG COVID patients
Measurement of ncRNAs and cytokines in patients who have never suffered from LONG COVID symptoms or with only resolved symptoms at the moment of the recruitment
Diagnostic test: Measurement of ncRNAs and cytokines
Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LONG COVID biomarkers
Time Frame: Year 1
Identification of ncRNAs as potential biomarker for the presence of LONG COVID symptoms.
Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LONG COVID_LCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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