Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT04346160
Status:
UNKNOWN
Last Update Posted:
2020-04-20
First Post:
2020-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Virus RNA, and miRNA Levels Related to Viral Infection, and Inflammatory Response in Tears of Patients Affected by COVID-19 Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tear fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-16', 'studyFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'virus molecular analysis', 'timeFrame': '2 weeks', 'description': '\\- to asses virus RNA and miRNA levels in tears'}, {'measure': 'host molecular analysis', 'timeFrame': '2 weeks', 'description': '\\- to asses inflammatory response molecules'}], 'secondaryOutcomes': [{'measure': 'Epidemiologic data', 'timeFrame': '2 weeks', 'description': 'To analyze the prevalence of conjunctivitis in patients with a diagnosis of COVID-19 and the assessment of the predictive value of conjunctivitis in the development of the COVID-19 disease (or in developing respiratory distress forms-ARDS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID', 'conjunctivitis', 'SARS-CoV2', 'miRNA', 'tear fluid'], 'conditions': ['COVID', 'Conjunctivitis']}, 'descriptionModule': {'briefSummary': "The aim of this study is to assess the virus RNA, and miRNA levels related to viral infection, and inflammatory response in tears of hospitalized patients with a diagnosis of COVID-19 with and without conjunctivitis and to correlate them with clinical condition.\n\nTears will be collected by using Schirmer Test I, a non invasive painless test which can be performed at the patient's bed. Tears will be collected on the graduated paper strips pulling the lower lid gently downward for 5 minutes. Following, the strip will be placed in a 2.0 mL Eppendorf tube and stored at -80◦C (or - 20°C)", 'detailedDescription': 'The SARS-CoV-2 is a virus highly infectious whose main target of infection is the respiratory tract. Virus has been reported to target other mucus tissues, such as the conjunctiva of the eye and causes conjunctivitis. A recent study has detected the presence of SARS-CoV-2 in the tears of patients affected by COVID-19 with conjunctivitis, using real-time reverse transcription polymerase chain reaction (RT-PCR). This suggests that droplets and body fluids of infected people can contaminate the human conjunctival mucosa and it can be a view of transmission that it must not be ignored.\n\nA role of miRNAs has been found in ocular infections such as fungal, bacterial, viral infections. It would be interesting to correlate tear fluid miRNA levels to patients clinical findings'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'a total of 25 patients with a diagnosis of COVID-19 with bilateral conjunctivitis (Group 1) and without conjunctivitis (Group 2) will be enrolled at the Anesthesia and Intensive Care department, the Infectious diseases department and the Emergency Medicine department, at the "SS. Annunziata Hospital" of Chieti-University G. D\'Annunzio, Chieti-Pescara, Italy, in April 2020. A group of healthy patients will be enrolled and were considered as controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Group 1):\n\n* A confirmed diagnosis of COVID-19 disease\n* Age ≥ of 18 years.\n* absence of conjuntivitis detected by portable slit lamp\n\nInclusion Criteria (Group 2):\n\n* A confirmed diagnosis of COVID-19 disease\n* Age ≥ of 18 years.\n* Presence of bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)\n\nExclusion Criteria (both groups):\n\n* Pregnant women\n* Any form Ocular surface diseases preceding Covid-19 diagnosis, Glaucoma, history of anterior segment inflammation, previous penetrating ocular trauma\n* Ocular surgeries within previous 6 months\n* Topical therapies\n* History of ocular allergy'}, 'identificationModule': {'nctId': 'NCT04346160', 'briefTitle': 'A Study to Assess the Virus RNA, and miRNA Levels Related to Viral Infection, and Inflammatory Response in Tears of Patients Affected by COVID-19 Disease', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': 'Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis', 'orgStudyIdInfo': {'id': 'UChieti03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with bilateral conjunctivitis', 'description': 'Hospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)', 'interventionNames': ['Diagnostic Test: Schirmer Test I']}, {'label': 'Patients without conjunctivitis', 'description': 'Hospitalized patient affected by COVID-19 disease without any signs of conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)', 'interventionNames': ['Diagnostic Test: Schirmer Test I']}, {'label': 'Healthy control group', 'description': 'group of healthy patients considered as controls', 'interventionNames': ['Diagnostic Test: Schirmer Test I']}], 'interventions': [{'name': 'Schirmer Test I', 'type': 'DIAGNOSTIC_TEST', 'description': 'Collection of tear fluid', 'armGroupLabels': ['Healthy control group', 'Patients with bilateral conjunctivitis', 'Patients without conjunctivitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66013', 'city': 'Chieti', 'country': 'Italy', 'facility': "Ophtalmology Clinic, G.d'Annunzio University", 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}], 'centralContacts': [{'name': 'Manuela Lanzini, Doctor', 'role': 'CONTACT', 'email': 'm.lanzini@unich.it', 'phone': '+393703005156'}], 'overallOfficials': [{'name': 'Leonardo Mastropasqua, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ophtalmology Clinic, G. d'Annunzio University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director, Professor', 'investigatorFullName': 'Leonardo Mastropasqua', 'investigatorAffiliation': "G. d'Annunzio University"}}}}