COVID-19NCT06881160
Mi-RNA and COVID-19
An observational study of COVID-19, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- mi-RNA analysis
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 18 years
- diagnosis of SARS-CoV-2 infection confirmed by molecular testing on nasopharyngeal swabs
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00167
Giovanni Tinelli, 0039 0630157205, giovanni.tinelli@policlinicogemelli.it
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- mi-RNA analysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mi-RNA analysisDiagnostic test
To identify biomarkers that could predict the risk of a worsened COVID-19 disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Mild Respiratory Failure Covid-19 | Patients with Covid-19 and mild respiratory failure defined as PaO2/FiO2 201-300 mm Hg Receives: 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. Receives: Diagnostic Test: mi-RNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Covid-19
Severity of the disease
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Mar 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881160
- Sponsor's protocol ID
- 3155
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Mi-RNA Associated With Disease Severity and Outcome in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT06881160
- Acronym / sponsor ID
- 3155
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Respiratory Failure Covid-19 | – | Diagnostic Test: mi-RNA analysisPatients with Covid-19 and mild respiratory failure defined as PaO2/FiO2 201-300 mm Hg |
| Severe Respiratory Failure Covid-19 | – | Diagnostic Test: mi-RNA analysisPatients with Covid-19 and severe respiratory failure defined as PaO2/FiO2 ≤100 mm Hg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 18 years
- diagnosis of SARS-CoV-2 infection confirmed by molecular testing on nasopharyngeal swabs
Key exclusion criteria (1 listed)
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mi-RNA analysisTo identify biomarkers that could predict the risk of a worsened COVID-19 disease progression. | Diagnostic test | Mild Respiratory Failure Covid-19, Severe Respiratory Failure Covid-19 |
Primary outcome
Severity of Covid-19
Time frame: Through study completion, an average of 1 year
Severity of the disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Covid-19 (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.