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Biomarkers of LONG COVID (LONG COVID_LCM) (LONG COVID_LCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05672602
Recruitment Status : Recruiting
First Posted : January 5, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Fabio Martelli, 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.

Condition or disease Intervention/treatment
Long COVID 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.

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Study Type : Observational
Estimated 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 : July 20, 2022
Actual Primary Completion Date : December 5, 2022
Estimated Study Completion Date : December 2023


Group/Cohort 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.




Primary Outcome Measures :
  1. LONG COVID biomarkers [ Time Frame: Year 1 ]
    Identification of ncRNAs as potential biomarker for the presence of LONG COVID symptoms.


Biospecimen Retention:   Samples Without DNA
Plasma samples and peripheral blood mononuclear cells (PBMCs)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients admitted to IRCCS Policlinico San Donato during the acute phase of COVID-19
Criteria

Inclusion Criteria:

  • Previous COVID-19 infection

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05672602


Contacts
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Contact: Fabio Martelli, Dr +39 0226437762 fabio.martelli@grupposandonato.it

Locations
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Italy
Irccs Policlinico San Donato Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: FABIO MARTELLI, PhD    0252774683    fabio.martelli@grupposandonato.it   
Sub-Investigator: MARCO RANUCCI, MD         
Sub-Investigator: EKATERINA BARYSHNIKOVA, PhD         
Sub-Investigator: ROSANNA CARDANI, PhD         
Sub-Investigator: SIMONA GRECO, PhD         
Sub-Investigator: ALISIA MADE', MSc         
Sponsors and Collaborators
IRCCS Policlinico S. Donato
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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: January 5, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Acute COVID-19 Syndrome
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