Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
Study NCT ID:
NCT04397666
Status:
UNKNOWN
Last Update Posted:
2021-08-09
First Post:
2020-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis', 'timeFrame': '3 months', 'description': 'to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV Infection', 'Pinkeye']}, 'descriptionModule': {'briefSummary': 'the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women positive for SARS-Cov-2 on a RT-PCR test of a sample of respiratory airway\n* Persons over 18 years of age\n* patients of both sexes\n* Member of a social security scheme\n* Having signed the consent form\n\nExclusion Criteria:\n\n* Minors not emancipated, persons out of state to express their consent\n* Participation in intervention research on Covid-19 involving experimental treatment\n* History of chronic disease conjunctiva\n* Patient with one of the one of the criteria of following gravity:\n\n 1. EN \\> or =30/min,\n 2. Pao2/Fio2 = or \\< 300,\n 3. confusion and/or disorientation,\n 4. hypotension (Tas90mmhg, requiring aggressive filling),\n 5. need for a invasive ventilation,\n 6. septic shock'}, 'identificationModule': {'nctId': 'NCT04397666', 'acronym': 'P20/09', 'briefTitle': 'RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'officialTitle': 'RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19', 'orgStudyIdInfo': {'id': 'P20/09_COVEYES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Diagnostic Test: conjunctival RT PCR']}], 'interventions': [{'name': 'conjunctival RT PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'conjunctival sample in covid-19 patients', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78390', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Centre Hospitalier de versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'coordonator investigator', 'investigatorFullName': 'Edouard KOCH', 'investigatorAffiliation': 'Versailles Hospital'}}}}