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Biomarkers of LONG COVID (LONG COVID_LCM)

Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Recruiting
CT.gov ID
NCT05672602
Collaborator
(none)
100
Enrollment
1
Location
10.4
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Measurement of ncRNAs and cytokines

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of Innovative Biomarkers of Systemic Inflammation in LONG COVID Patients
Actual Study Start Date :
Jul 20, 2022
Actual Primary Completion Date :
Dec 5, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. LONG COVID biomarkers [Year 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Previous COVID-19 infection
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Irccs Policlinico San Donato San Donato Milanese Milan Italy 20097

Sponsors and Collaborators

  • IRCCS Policlinico S. Donato

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fabio Martelli, Dr, PhD, Molecular Cardiology Laboratory Director, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier:
NCT05672602
Other Study ID Numbers:
  • LONG COVID_LCM
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 5, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 5, 2023