Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-27 @ 7:25 PM
Study NCT ID:
NCT04799704
Status:
TERMINATED
Last Update Posted:
2025-01-24
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D005128', 'term': 'Eye Diseases'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heleen.delbeke@uzleuven.be', 'phone': '003216342229', 'title': 'Heleen Delbeke, MD', 'organization': 'UZ Leuven'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Sampling will be repeated every 3 days to evaluate if PCR becomes positive during the course of disease and to monitor the duration of detectability of the virus in tears, up to 1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Symptomatic Patient', 'description': 'The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.\n\nswabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}, {'units': 'swabs', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic Patient', 'description': 'The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.\n\nswabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab'}], 'classes': [{'title': 'positive SARS-CoV-2 swab', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'strongly positive SARS-CoV-2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'weakly positive SARS-CoV-2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during hospitalization every 3 days until the day of discharge up to 1 month', 'description': 'Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.', 'unitOfMeasure': 'swabs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'swabs', 'denomUnitsSelected': 'swabs', 'populationDescription': 'symptomatic patients admitted at our University Hospital Leuven, Belgium with a positive nasopharyngeal swab for SARS-nCoV-2'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symptomatic Patient', 'description': 'The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.\n\nswabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '176', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '176', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'swabs', 'recruitmentDetails': 'Conjunctival sampling will take place every three days until the day of hospital discharge.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Symptomatic Patient', 'description': 'The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.\n\nswabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65', 'spread': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-16', 'size': 2832579, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-23T09:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'insufficient positive samples', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2021-03-11', 'resultsFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-17', 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.', 'timeFrame': 'during hospitalization every 3 days until the day of discharge up to 1 month', 'description': 'Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Eye Diseases']}, 'referencesModule': {'references': [{'pmid': '35367365', 'type': 'RESULT', 'citation': 'Leysen L, Delbeke H, Desmet S, Schauwvlieghe PP, Maes P, Blanckaert G, Matthys E, Joossens M, Casteels I. In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients. Clin Microbiol Infect. 2022 Aug;28(8):1172-1173. doi: 10.1016/j.cmi.2022.03.026. Epub 2022 Mar 31. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.cmi.2022.03.026', 'label': 'In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.', 'detailedDescription': 'The end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling.\n\nA sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. In addition, you must complete a questionnaire that assesses the symptoms present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'positive test for SARS-nCoV-2 on a nasopharyngeal swab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject needs to be above 18 years old.\n* The subject is willing to undergo sampling of the conjunctiva.\n* The subject is willing to fill in a questionnaire.\n* The subject is fluent in written and verbal Dutch.\n* The subject is capable of giving informed consent.\n* Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days.\n\nExclusion Criteria:\n\n* Allergy to Oxybuprocainehydrochloride\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT04799704', 'acronym': 'Eye-Covid', 'briefTitle': 'Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic', 'orgStudyIdInfo': {'id': 'S64002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'symptomatic patient', 'description': 'to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.', 'interventionNames': ['Diagnostic Test: swabbing of conjunctiva']}], 'interventions': [{'name': 'swabbing of conjunctiva', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each eye will be sampled with a single, sterile, nylon, flocked swab', 'armGroupLabels': ['symptomatic patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Delbeke Heleen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}