Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-31 @ 3:58 PM
Study NCT ID:
NCT04368260
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ajm5b@virginia.edu', 'phone': '434-924-9678', 'title': 'Dr. Amy Mathers', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 Day', 'eventGroups': [{'id': 'EG000', 'title': 'Control Swab', 'description': 'FDA cleared swab\n\nControl swab: FDA-cleared nasopharyngeal swab', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prototype Swab', 'description': 'Injection molded polypropylene flocked nylon NP swab\n\nPrototype swab: Injection molded polypropylene flocked nylon nasopharyngeal swab', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Swab', 'description': 'FDA cleared swab\n\nControl swab: FDA-cleared nasopharyngeal swab'}, {'id': 'OG001', 'title': 'Prototype Swab', 'description': 'Injection molded polypropylene flocked nylon NP swab\n\nPrototype swab: Injection molded polypropylene flocked nylon nasopharyngeal swab'}], 'classes': [{'title': 'Positive Sample', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Negative Sample', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at time of enrollment', 'description': 'Both the prototype and control nasopharyngeal swabs will be utilized in each subject. The rate of agreement between the swabs will be determined by the number of subjects for which both swabs provide the same COVID-19 PCR result.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': '40 subjects with either presumed positive COVID-19 status or presumed negative COVID-19 status were included in this study. Control and prototype nasopharyngeal swabs were collected from each subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': '40 subjects with either presumed positive COVID-19 status or presumed negative COVID-19 status were included in this study. Control and prototype nasopharyngeal swabs were collected from each subject.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presumed COVID-19 Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Presumed COVID-19 Positive', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Presumed COVID-19 Negative', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-21', 'size': 1280322, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-09T11:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2020-04-24', 'resultsFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-09', 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result', 'timeFrame': 'at time of enrollment', 'description': 'Both the prototype and control nasopharyngeal swabs will be utilized in each subject. The rate of agreement between the swabs will be determined by the number of subjects for which both swabs provide the same COVID-19 PCR result.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['COVID19']}, 'descriptionModule': {'briefSummary': 'The SARS-CoV-2 pandemic has resulted in an international shortage of the nasopharyngeal (NP) swabs used to collect sample for virological testing. This shortage has become a crisis as testing capacity is growing, and threatens to become the bottleneck at University of Virginia Health System and in the Commonwealth of Virginia, as it already is in other testing centers. To resolve this crisis, a team in the Clinical Microbiology Laboratories at University of Virginia Medical Center has been working closely with biomedical engineers in the University of Virginia (UVA), School of Engineering and with high volume domestic manufacturers developing injection molded polypropylene flocked nylon NP swab.\n\nThis prototype will be tested for non-inferiority relative to existing, already validated NP swabs ("control swab") for purposes of molecular microbiology: i.e. the polymerase chain reaction (PCR) tests used for virological testing for SARS-CoV-2. Specifically, the nasopharynx of patients with Covid-19 and patients under investigation (PUI) for Covid-19, the disease caused by SARS-CoV-2, will be swabbed using a prototype swab and a control swab (the standard of care swab), and test for concordance of SARS-CoV-2. In all cases the swab will be transported in validated FDA cleared viral transport medium (VTM) as per standard operating procedure at University of Virginia Medical Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '0 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals presenting to the site for clinical care will be evaluated for clinical screening for Covid-19 testing or other respiratory infection testing.\n* Individuals felt identified clinically as needing Covid-19 testing may be approached for study participation.\n* Individuals already under clinical care that have tested positive for Covid-19 will be approached for study participation.\n* Volunteer health care workers who have approached the Principal Investigator\n\nExclusion Criteria:\n\n* Known thrombocytopenia of \\<50,000 platelets/μl (risk of mild bleeding).\n* Individuals presenting with an anatomically altered nasal cavity.\n* Pregnant (self-reported)\n* No other patients will be specifically excluded.'}, 'identificationModule': {'nctId': 'NCT04368260', 'briefTitle': 'Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': 'HSR200127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control swab', 'description': 'FDA cleared swab', 'interventionNames': ['Device: Control swab']}, {'type': 'EXPERIMENTAL', 'label': 'Prototype swab', 'description': 'Injection molded polypropylene flocked nylon NP swab', 'interventionNames': ['Device: Prototype swab']}], 'interventions': [{'name': 'Control swab', 'type': 'DEVICE', 'description': 'FDA-cleared nasopharyngeal swab', 'armGroupLabels': ['Control swab']}, {'name': 'Prototype swab', 'type': 'DEVICE', 'description': 'Injection molded polypropylene flocked nylon nasopharyngeal swab', 'armGroupLabels': ['Prototype swab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Amy Mathers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'All individual participant data (IPD) that underlie results in a publication will be shared.', 'accessCriteria': 'Requests to made to Principal Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Medicine, Infectious Disease', 'investigatorFullName': 'Amy Mathers, MD', 'investigatorAffiliation': 'University of Virginia'}}}}