Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT06881160
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2023-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mi-RNA and COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2023-03-12', 'studyFirstSubmitQcDate': '2025-03-15', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Covid-19', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Severity of the disease'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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).\n\nThe aim of the present study is to analyze miRNAs associated with SARS-CoV-2 infection, disease severity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years\n* diagnosis of SARS-CoV-2 infection confirmed by molecular testing on nasopharyngeal swabs\n\nExclusion Criteria:\n\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT06881160', 'briefTitle': 'Mi-RNA and COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Circulating Mi-RNA Associated With Disease Severity and Outcome in COVID-19 Patients', 'orgStudyIdInfo': {'id': '3155'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild Respiratory Failure Covid-19', 'description': 'Patients with Covid-19 and mild respiratory failure defined as PaO2/FiO2 201-300 mm Hg', 'interventionNames': ['Diagnostic Test: mi-RNA analysis']}, {'label': 'Severe Respiratory Failure Covid-19', 'description': 'Patients with Covid-19 and severe respiratory failure defined as PaO2/FiO2 ≤100 mm Hg.', 'interventionNames': ['Diagnostic Test: mi-RNA analysis']}], 'interventions': [{'name': 'mi-RNA analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'To identify biomarkers that could predict the risk of a worsened COVID-19 disease progression.', 'armGroupLabels': ['Mild Respiratory Failure Covid-19', 'Severe Respiratory Failure Covid-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00167', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Tinelli', 'role': 'CONTACT', 'email': 'giovanni.tinelli@policlinicogemelli.it', 'phone': '0039 0630157205'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Vascular Surgery', 'investigatorFullName': 'TINELLI GIOVANNI', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}