Biomarkers of LONG COVID (LONG COVID_LCM)

Completed

• Conditions: Long COVID
• Interventions: Diagnostic Test: Measurement of ncRNAs and cytokines

• Registration Number: NCT05672602
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

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 Timeline

• Study Start: 2022-07-20
• Primary Completion: 2022-12-05
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Study Completion: 2025-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Previous COVID-19 infection

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LONG COVID patients	Measurement of ncRNAs and cytokines	Measurement of ncRNAs and cytokines in patients with new diseases or intermittent or permanent symptoms after COVID-19 at the moment of the recruitment
Controls	Measurement of ncRNAs and cytokines	Measurement of ncRNAs and cytokines in Individuals who have never suffered from COVID-19 at the moment of the recruitment
Asymptomatic LONG COVID patients	Measurement of ncRNAs and cytokines	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

Primary Outcome Measures

Name	Time	Method
LONG COVID biomarkers	Year 1	Identification of ncRNAs as potential biomarker for the presence of LONG COVID symptoms.

Trial Locations

Locations (1)

Irccs Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy