Biomarkers of LONG COVID (LONG COVID_LCM)

NCT05672602 | Completed DMC

• 1 other identifier: LONG COVID_LCM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• LONG COVID biomarkers

  Identification of ncRNAs as potential biomarker for the presence of LONG COVID symptoms.

  Year 1

Study Arms (3)

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

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

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

Interventions

Measurement of ncRNAs and cytokines DIAGNOSTIC_TEST

Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.

Asymptomatic LONG COVID patients; Controls; LONG COVID patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Previous COVID-19 infection

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

Irccs Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples and peripheral blood mononuclear cells (PBMCs)

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, PhD, Molecular Cardiology Laboratory Director

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: July 20, 2022
• Primary Completion: December 5, 2022
• Study Completion: January 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)