Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04959760
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Operator of the device will be blinded to the outcome'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.'}, {'measure': 'Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.'}], 'secondaryOutcomes': [{'measure': 'Professional user usability', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User'}, {'measure': 'Self Test user usability', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.'}, {'measure': 'Matrix Equivalence Professional Use', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Validation of the Matrix Equivalence between the Fingerstick Whole Blood and Plasma samples when used with the BinaxNOW COVID-19 IgG Rapid Test Device.'}, {'measure': 'Diagnostic sensitivity and specificity', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'To determine the diagnostic sensitivity, specificity and overall agreement of the BinaxNOW™ COVID-19 Antibody Self Test as performed by lay users in comparison with the BinaxNOW™ COVID-19 IgG Rapid Test Device as performed by professional user.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['COVID-19 Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is 18 years of age or older.\n2. Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset \\> 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR\n\n Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.\n3. Participant agrees to complete all aspects of the study.\n\nExclusion Criteria:\n\n1. Participant has already participated in this study on a previous occasion.\n2. Participant is enrolled in a study to evaluate a new drug.\n3. Participant has a visual impairment that cannot be restored using glasses or contact lenses.\n4. Participant is unable or unwilling to provide informed consent.\n5. Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.\n6. Participant has a condition deemed unfit to safely perform the test by the investigator.\n7. Participant is a practising health-care professional or laboratory scientist / technician.'}, 'identificationModule': {'nctId': 'NCT04959760', 'briefTitle': 'BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Rapid Dx'}, 'officialTitle': 'Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol', 'orgStudyIdInfo': {'id': 'CLDG-0511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BinaxNow Covid-19 Antibody test', 'description': 'The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.', 'interventionNames': ['Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.']}], 'interventions': [{'name': 'The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.', 'type': 'DIAGNOSTIC_TEST', 'description': 'The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.', 'armGroupLabels': ['BinaxNow Covid-19 Antibody test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '29611', 'city': 'Powdersville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Urgent Care Clinical Trials', 'geoPoint': {'lat': 34.79178, 'lon': -82.49291}}, {'zip': '37209', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Urgent Care Clinical Trials at Complete Health Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75204', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Urgent Care Clinical Trials', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Simon Kordowich', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Rapid Diagnostics Jena GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}