Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-01 @ 6:21 PM
Study NCT ID:
NCT04609969
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of COVID VIRO® diagnostic specificity', 'timeFrame': 'Month 1', 'description': 'COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas:\n\nSpecificity (%) = 100 x \\[Negative / (Negative + Positive)\\]'}, {'measure': 'Evaluation of COVID VIRO® diagnostic sensitivity', 'timeFrame': 'Month 1', 'description': 'COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas:\n\nSensitivity (%) = 100 x \\[Positive/ (Positive + Negative)\\]'}], 'secondaryOutcomes': [{'measure': 'Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28', 'timeFrame': 'Month 1', 'description': 'COVID-VIRO® sensitivity is calculated using the RT-qPCR results, restricting for Cycle threshold value'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2 infection', 'COVID19', 'Antigen detection test'], 'conditions': ['Covid19', 'SARS-CoV-2 Infection']}, 'referencesModule': {'references': [{'pmid': '32383182', 'type': 'BACKGROUND', 'citation': 'Drame M, Tabue Teguo M, Proye E, Hequet F, Hentzien M, Kanagaratnam L, Godaert L. Should RT-PCR be considered a gold standard in the diagnosis of COVID-19? J Med Virol. 2020 Nov;92(11):2312-2313. doi: 10.1002/jmv.25996. Epub 2020 Jul 14. No abstract available.'}, {'pmid': '32302278', 'type': 'BACKGROUND', 'citation': 'Zitek T. The Appropriate Use of Testing for COVID-19. West J Emerg Med. 2020 Apr 13;21(3):470-472. doi: 10.5811/westjem.2020.4.47370.'}], 'seeAlsoLinks': [{'url': 'https://covid19.who.int/', 'label': 'WHO coronavirus Dashboard on Sept 15th,2020'}, {'url': 'https://www.santepubliquefrance.fr/dossiers/coronavirus-covid-19', 'label': 'France Epidemiologic situation on 2020 september 20th'}]}, 'descriptionModule': {'briefSummary': 'The current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting', 'detailedDescription': "Two nasopharyngeal swab specimens will be concurrently collected on:\n\n* adult patients hospitalized in the Infectious Diseases Department of the Centre Hospitalier Régional d'Orléans (CHRO) for confirmed SARS-CoV-2 infection,\n* or symptomatic or asymptomatic subjects voluntarily accessing the COVID-19 Screening Department of the CHRO to perform a diagnostic test. COVID VIRO® diagnostic.\n\nSpecificity and sensitivity are assessed in comparison to real-time RT-qPCR results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days\n* Adult patients (\\>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason\n\nExclusion Criteria:\n\n* Patients non wishing to participate\n* Under guardianship or curatorship or safeguard of justice patients\n* Inability to join the hospital other than by public transport'}, 'identificationModule': {'nctId': 'NCT04609969', 'acronym': 'COVID-VIRO', 'briefTitle': 'Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier Régional d'Orléans"}, 'officialTitle': 'Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i', 'orgStudyIdInfo': {'id': 'CHRO-2020-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens', 'description': 'Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.', 'interventionNames': ['Diagnostic Test: RT-qPCR test', 'Diagnostic Test: COVID-VIRO® test']}], 'interventions': [{'name': 'RT-qPCR test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.', 'armGroupLabels': ['Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens']}, {'name': 'COVID-VIRO® test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.', 'armGroupLabels': ['Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45000', 'city': 'Orléans', 'country': 'France', 'facility': "Centre Hospitalier Régional d'Orléans, France", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}], 'overallOfficials': [{'name': 'Thierry PRAZUCK, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR ORLEANS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier Régional d'Orléans", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}