Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT06360757
Status:
TERMINATED
Last Update Posted:
2025-03-18
First Post:
2024-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasopharyngeal swabs in UTM or UVT'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 503}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Discontinuation of product line', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity as compared to the comparator method', 'timeFrame': 'Through study completion estimated 9 months', 'description': 'Sensitivity ≥ 95% with a lower bound of the two-sided 95% CI \\> 90%'}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': 'Through study completion estimated 9 months', 'description': 'Specificity ≥ 95% with a lower bound of the two-sided 95% CI \\> 90%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2 Acute Respiratory Disease']}, 'descriptionModule': {'briefSummary': "A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Symptomatic subjects suspected of COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any de-identified NP swab specimen in transport medium from a symptomatic individual suspected of COVID-19 at the time of collection.\n2. NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM \\[Cat. No. 305C\\] or BD UVT \\[Cat. No. 220531\\].\n3. Prospective specimens, fresh (Category I) shall be tested within:\n\n 1. (4) hours when held at room temperature, or\n 2. (3) days when held at (2 to 8°C), with cold storage starting within (4) hours of collection.\n4. Minimum volume of ≥ 2mL.\n\nExclusion Criteria:\n\n1. Required information unable to be obtained from the associated medical chart.\n2. Specimens that remained on-board the NeuMoDx System for \\> (8) hours prior to processing.'}, 'identificationModule': {'nctId': 'NCT06360757', 'briefTitle': 'Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'QIAGEN Gaithersburg, Inc'}, 'officialTitle': 'Multi-Center Clinical Performance Evaluation of the NeuMoDx SARS-CoV-2 Assay on the NeuMoDx Molecular Systems', 'orgStudyIdInfo': {'id': 'DHF-21-2141-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NeuMoDx SARS-CoV-2 Assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'The NeuMoDx™ SARS-CoV-2 Assay is an automated, in vitro nucleic acid amplification test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal (NP) swabs in transport medium obtained from symptomatic individuals suspected of COVID-19 infection. The NeuMoDx SARS-CoV-2 Assay as performed on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System incorporates automated RNA extraction to isolate target nucleic acids from the specimen and real-time reverse transcription PCR targeting two conserved regions of the SARS-CoV-2 genome.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M130BH', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'QIAGEN Gaithersburg, Inc', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QIAGEN Gaithersburg, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}