Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 5:20 AM
Study NCT ID:
NCT04981769
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Covid-19 PCR test result', 'timeFrame': '90 minutes', 'description': 'Molecular Covid-19 testing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.', 'detailedDescription': 'Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '125 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible subjects presenting to clinical site for Covid-19 testing', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.\n\nExclusion Criteria:\n\n* Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing'}, 'identificationModule': {'nctId': 'NCT04981769', 'briefTitle': 'POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anavasi Diagnostics'}, 'officialTitle': 'POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test', 'orgStudyIdInfo': {'id': '003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients presenting to clinical sites for Covid-19 testing who are 2 years of age or older.', 'interventionNames': ['Diagnostic Test: Covid-19 test']}], 'interventions': [{'name': 'Covid-19 test', 'type': 'DIAGNOSTIC_TEST', 'description': 'PCR Covid-19 test', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael Blaivas, MD', 'role': 'CONTACT', 'email': 'mike.blaivas@anavasidx.com', 'phone': '770-205-7721'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anavasi Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}