Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-16 @ 10:06 AM
Study NCT ID:
NCT04877002
Status:
TERMINATED
Last Update Posted:
2023-03-24
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Study of SONA Saliva C-19 Rapid Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Test for rapid detection of SARS\\_CoV\\_2 infection when using saliva specimens. A prospective randomized and blinded study to evaluate a rapid point of care antigen test for the detection of viral proteins and compared against an approved RT-PCR test.\n\nSaliva samples will be collected along with the current standard of care collection.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Limited participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Positive Agreement and Negative Percent Agreement', 'timeFrame': '35 days from last patient enrolment', 'description': 'Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antigen', 'COVID19', 'Rapid Test', 'Saliva'], 'conditions': ['Covid19', 'Sars-CoV-2 Infection', 'Corona Virus Infection']}, 'descriptionModule': {'briefSummary': 'The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method', 'detailedDescription': "The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda.\n\nConsenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested.\n\nTrained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users.\n\nA subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUp to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Presenting to the Emergency Department at HRH.\n2. Receiving a COVID-19 RT-PCR test as per standard pathway of care.\n3. Provide written informed consent.\n4. Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days:\n\n 1. Fever as self-described or measured ≥ 38 °C (100.4°F)\n 2. Chills\n 3. Cough\n 4. Shortness of breath\n 5. Congestion or runny nose\n 6. Difficulty Breathing\n 7. Muscle or Body Aches\n 8. Vomiting\n 9. Diarrhea\n 10. New loss of sense of taste or smell\n 11. Headache\n 12. General malaise\n 13. Sore Throat\n\nExclusion Criteria:\n\n1. Asymptomatic patients.\n2. Patients unable to provide a saliva sample.\n3. Patients unable to give consent.\n4. Patients who will not be receiving a nasopharyngeal RT-PCR test.'}, 'identificationModule': {'nctId': 'NCT04877002', 'briefTitle': 'Performance Study of SONA Saliva C-19 Rapid Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sona Nanotech Inc'}, 'officialTitle': 'Novel Salivary Rapid Testing of SARS_CoV_2', 'orgStudyIdInfo': {'id': 'CT002-SalC19RT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SARS_CoV_2 Antigen Rapid Test', 'description': 'The same group of patients participated in two arms of the study:\n\nOne arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing.', 'interventionNames': ['Diagnostic Test: Sona Saliva C-19 Rapid Test']}], 'interventions': [{'name': 'Sona Saliva C-19 Rapid Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Rapid Antigen diagnostic device performance comparative to RT-PCR', 'armGroupLabels': ['SARS_CoV_2 Antigen Rapid Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M3M 0B2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Humber River Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'David Jacobs, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humber River Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sona Nanotech Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}