Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-01 @ 4:21 AM
Study NCT ID:
NCT05140005
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2021-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GlowTest COVID-19 Antigen Home Test Kit QRI Use Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QRI Usability - Observer', 'timeFrame': '90 minutes', 'description': 'Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.'}, {'measure': 'QRI Usability - Participant', 'timeFrame': '90 minutes', 'description': 'Assess the usability of the kit for home use based upon participant evaluation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Virus'], 'conditions': ['Covid 19']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.', 'detailedDescription': 'The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use. The Arion Bio GlowTest COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals aged 2 to 13. The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.\n\n30 subjects (including both English speaking and Spanish speaking) will be split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child). There will be one testing site in the United States (US).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.\n* Males and females ages 2 and older.\n* Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)\n* Subject agrees to complete all aspects of the study\n\nExclusion Criteria:\n\n* Subject has a visual impairment that cannot be restored with glasses or contact lenses.\n* Subject has prior medical or laboratory training.\n* Subject uses home diagnostics, e.g., glucose meters, HIV tests.\n* Subject has prior experience with home COVID test kits.'}, 'identificationModule': {'nctId': 'NCT05140005', 'briefTitle': 'GlowTest COVID-19 Antigen Home Test Kit QRI Use Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arion Bio'}, 'officialTitle': 'GlowTest COVID-19 Antigen Home Test Kit Usability Study', 'orgStudyIdInfo': {'id': 'AB-001-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '15 subjects testing themselves', 'description': '15 subjects will use the Glow Test Kit to test themselves for Covid 19.', 'interventionNames': ['Diagnostic Test: GlowTest COVID-19 Antigen Home Test']}, {'type': 'OTHER', 'label': '15 subjects testing someone else', 'description': '15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19.', 'interventionNames': ['Diagnostic Test: GlowTest COVID-19 Antigen Home Test']}], 'interventions': [{'name': 'GlowTest COVID-19 Antigen Home Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['GlowTest'], 'description': 'diagnostic testing for Covid 19', 'armGroupLabels': ['15 subjects testing someone else', '15 subjects testing themselves']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'facility': 'Centennial Medical', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}], 'overallOfficials': [{'name': 'Steven Geller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centennial Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arion Bio', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CSSi Life Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}