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NCT05672602 Clinical Trial

Biomarkers of LONG COVID (LONG COVID_LCM)

Long COVID Clinical Trial

— LONG COVID_LCM  

Official title:
Study of Innovative Biomarkers of Systemic Inflammation in LONG COVID Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05672602
Other study ID # LONG COVID_LCM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 20, 2022
Est. completion date December 2023

Study information
Verified date September 2023
Source IRCCS Policlinico S. Donato
Contact Fabio Martelli, Dr
Phone +39 0226437762
Email fabio.martelli@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date December 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Previous COVID-19 infection Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Measurement of ncRNAs and cytokines
Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.

Locations
Country Name City State
Italy Irccs Policlinico San Donato San Donato Milanese Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary LONG COVID biomarkers Identification of ncRNAs as potential biomarker for the presence of LONG COVID symptoms. Year 1
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