Mi-RNA and COVID-19

March 15, 2025 updated by: TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Circulating Mi-RNA Associated With Disease Severity and Outcome in COVID-19 Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
To identify biomarkers that could predict the risk of a worsened COVID-19 disease progression.
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
To identify biomarkers that could predict the risk of a worsened COVID-19 disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Covid-19
Time Frame: Through study completion, an average of 1 year
Severity of the disease
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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