Mi-RNA and COVID-19

NCT06881160 | Recruiting

• 1 other identifier: 3155
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), induces a spectrum of clinical conditions ranging from asymptomatic infection to life threatening severe disease, characterized by respiratory failure, shock and multi-organ dysfunction requiring admission in the intensive care unit (ICU). The aim of the present study is to analyze miRNAs associated with SARS-CoV-2 infection, disease severity and mortality.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Severity of Covid-19

  Severity of the disease

  Through study completion, an average of 1 year

Study Arms (2)

Mild Respiratory Failure Covid-19

Patients with Covid-19 and mild respiratory failure defined as PaO2/FiO2 201-300 mm Hg

Diagnostic Test: mi-RNA analysis

Severe Respiratory Failure Covid-19

Patients with Covid-19 and severe respiratory failure defined as PaO2/FiO2 ≤100 mm Hg.

Diagnostic Test: mi-RNA analysis

Interventions

mi-RNA analysis DIAGNOSTIC_TEST

To identify biomarkers that could predict the risk of a worsened COVID-19 disease progression.

Mild Respiratory Failure Covid-19; Severe Respiratory Failure Covid-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted at the Fondazione Policlinico Gemelli IRCCS hospital with Covid-19 were enrolled. Peripheral blood samples were collected at the time of hospital admission. Plasma were separated from whole blood by centrifugation for 15 min at 3.000 rpm at 4°C and stored at -80°C until processing

You may qualify if:

• years
• diagnosis of SARS-CoV-2 infection confirmed by molecular testing on nasopharyngeal swabs

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Plasma

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 18, 2025
• Study Start: March 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)