Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT04805892
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jstega@optonline.net', 'phone': '6464001204', 'title': 'Zanetta Malanowska-Stega', 'organization': 'Quality Research and Invention LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 visit - up to 2 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Biozek Covid-19 Antigen Test', 'description': 'No adverse events were reported.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOZEK COVID-19 Antigen Rapid Test', 'description': 'BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care.'}], 'classes': [{'title': 'Sensitivity - Test performed by trained study personnel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Specifity - Test performed by trained study personnel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 visit, up to 2 hours', 'description': 'The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)\\*100% formula.\n\nSpecificity was calculated using (TN/TN+FP)\\*100% formula.', 'unitOfMeasure': 'percentage - Sensitivity and specificity', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from the analysis due to inconclusive results.'}, {'type': 'SECONDARY', 'title': 'Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOZEK COVID-19 Antigen Rapid Test', 'description': 'BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care.'}], 'classes': [{'title': 'Sensitivity - Test performed by the subject', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Specificity - Test performed by the subject', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 visit, up to 2 hours', 'description': 'The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)\\*100% formula.\n\nSpecificity was calculated using (TN/TN+FP)\\*100% formula.', 'unitOfMeasure': 'percentage - Sensitivity and specificity', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from the analysis due to inconclusive results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIOZEK COVID-19 Antigen Rapid Test', 'description': 'BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Single site study was performed by Mobile Covid Services, a COVID-19 testing concierge service. Enrollment and testing took place at the subject's home. The Enrollment population consisted of symptomatic and asymptomatic subjects scheduled for an appointment to perform an RT-PCR test for SARS-CoV-2 as the standard of care procedure."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BIOZEK COVID-19 Antigen Rapid Test', 'description': 'BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 18 - 85 years', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-05', 'size': 548837, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-25T11:31', 'hasProtocol': True}, {'date': '2021-03-17', 'size': 410699, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-25T11:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2021-03-17', 'resultsFirstSubmitDate': '2023-02-25', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-11', 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.', 'timeFrame': '1 visit, up to 2 hours', 'description': 'The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)\\*100% formula.\n\nSpecificity was calculated using (TN/TN+FP)\\*100% formula.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.', 'timeFrame': '1 visit, up to 2 hours', 'description': 'The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)\\*100% formula.\n\nSpecificity was calculated using (TN/TN+FP)\\*100% formula.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on samples collected by a healthcare professional versus self-collection; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.\n\nSubjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:\n\n* Currently experiencing symptoms of COVID-19.\n* Be clinically diagnosed or suspected to have COVID-19.\n* Recent past (3 weeks) exhibited symptoms of COVID-19.\n* Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.\n* Interacted with a COVID-19 positive individual.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria may not be enrolled in this study:\n\n* Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.\n* Have a deviated nasal septum.\n* Cognitively impaired individuals resulting in the inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04805892', 'briefTitle': 'Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mach-E B.V.'}, 'officialTitle': 'Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test as Compared to Standard Testing Technique. Test Performed by a Professional Versus Self-collection and Standard of Care', 'orgStudyIdInfo': {'id': '#Biozek-ARTC-US'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BIOZEK COVID-19 Antigen Rapid Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The BIOZEK COVID-19 Antigen Rapid Test is used for the detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals who are suspected of having COVID-19.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11354', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'Mobile Covid Services LLC', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mach-E B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}