Biomarkers of LONG COVID (LONG COVID_LCM)

Study Overview
=================
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.

Official Title
-----------------
Study of Innovative Biomarkers of Systemic Inflammation in LONG COVID Patients

Conditions
-----------------
Long COVID

Intervention / Treatment
-----------------
* Diagnostic Test: Measurement of ncRNAs and cytokines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous COVID-19 infection Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LONG COVID patients<br>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<br>* Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.<br>|
| Controls<br>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<br>* Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.<br>|
| Asymptomatic LONG COVID patients<br>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<br>* Measurement of lncRNAs in PBMCs samples and miRNAs in plasma samples.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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