Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-05 @ 5:38 PM
Study NCT ID:
NCT06008457
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2023-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Remnant swab samples from all subjects (positive and negative) and isolated viral DNA will be maintained for future related research. No human DNA will be maintained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1600}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection method comparison', 'timeFrame': '1 day', 'description': 'To evaluate the concordance between the results of a self-collected AN swab specimen using the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as analyzed by the Labcorp Seasonal Respiratory Virus RT-PCR Test and an HCP-collected AN swab as analyzed by the comparator assays in subjects presenting with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19.'}], 'secondaryOutcomes': [{'measure': 'Whole blood specimen collection', 'timeFrame': '1 day', 'description': 'The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Respiratory Infection', 'Influenza A', 'Influenza Type B', 'RSV Infection']}, 'descriptionModule': {'briefSummary': 'To compare the results obtained by analysis of a self-collected anterior nasal (AN) swab as part of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit to a healthcare provider (HCP)-collected AN swab in patients with symptoms of viral respiratory infection consistent with influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV) and/or SARS-CoV-2 (C-19).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female patients ≥2 years of age who present to the participating study clinics with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19 and who meet all study inclusion criteria and no exclusion criteria will be considered for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presents with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19;\n* Subject can read and understand written instructions in English; and\n* Subject is able, in the professional opinion of the investigator, to provide up to 18.5mL of whole blood at the clinic visit. NOTE - the blood draw will be optional for subjects \\<12 years of age.\n\nExclusion Criteria:\n\n* Subject is 14-17 years of age and their parent or legal guardian is unable to supervise the collection of the AN swab sample from the subject;\n* Subject is \\<14 years of age and their parent or legal guardian refuses to collect the AN swab sample from the subject; or\n* Previous participation in this protocol.'}, 'identificationModule': {'nctId': 'NCT06008457', 'briefTitle': 'Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sequenom, Inc.'}, 'officialTitle': 'Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study', 'orgStudyIdInfo': {'id': 'SQNM-VIR-403'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Self-collection first', 'description': 'Subjects will self-collect an anterior nasal swab first', 'interventionNames': ['Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit']}, {'label': 'HCP-collection first', 'description': 'Subjects will have their healthcare provider collect an anterior nasal swab first', 'interventionNames': ['Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit']}], 'interventions': [{'name': 'Labcorp COVID-19+Flu+RSV Test Home Collection Kit', 'type': 'DEVICE', 'description': 'The self-collected Labcorp COVID-19+Flu+RSV Test Home Collection Kit results as generated by the commercially available Labcorp Seasonal Respiratory Virus RT-PCR Test will be compared to the HCP-collected results as generated by Labcorp R\\&D using the comparator assays.', 'armGroupLabels': ['HCP-collection first', 'Self-collection first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Exer Urgent Care', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Graham McLennan, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Laboratory Corporation of America'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sequenom, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Labcorp Corporation of America Holdings, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}