Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04767958
Status:
TERMINATED
Last Update Posted:
2022-05-02
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a cohort study of participants falling into one of four groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'whyStopped': 'Device pulled from market due to inconsistent results.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'In hospital outcomes', 'timeFrame': '16 months', 'description': 'In hospital outcomes include death, pneumonia, intubation, myocardial infarction, urgent revascularization,mechanical device support, transplant'}, {'measure': 'Length of hospital admission', 'timeFrame': '16 months', 'description': 'Total number of days in hospital will be collected'}], 'primaryOutcomes': [{'measure': 'Sensitivity of POC testing as compared to core lab testing', 'timeFrame': '3 months', 'description': 'Specificity, positive/negative predictive values will be derived'}], 'secondaryOutcomes': [{'measure': 'Incidence in which decision making would have been altered by POC testing', 'timeFrame': '12 months', 'description': 'examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada.', 'detailedDescription': 'This RAPID COVID-19 study is a prospective, unblinded clinical trial. POC testing utilizing the Spartan Cube COVID-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for COVID-19.\n\nThis cohort will be divided into three groups:\n\n1. patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital\n2. patients undergoing cardiac testing and/or procedures\n3. patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test.\n\nAn additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants \\>/= 18 years of age\n* patients for whom POC testing would change their course of treatment (in opinion of treatment team)\n\nExclusion Criteria:\n\n* patients in whom conventional COVID-19 testing would not have otherwise been performed\n* patients in whom immediate COVID-19 testing would not alter short-term treatment\n* patients who refuse consent'}, 'identificationModule': {'nctId': 'NCT04767958', 'acronym': 'RAPID COVID', 'briefTitle': 'The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff', 'orgStudyIdInfo': {'id': '20200858-01T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission', 'description': 'All patients will have both standard care and point-of-care (experimental) NP swabs performed.', 'interventionNames': ['Diagnostic Test: Spartan COVID-19 Platform']}, {'type': 'EXPERIMENTAL', 'label': 'patients undergoing cardiac testing/procedures', 'description': 'All patients will have both standard care and point-of-care (experimental) NP swabs performed.', 'interventionNames': ['Diagnostic Test: Spartan COVID-19 Platform']}, {'type': 'EXPERIMENTAL', 'label': 'patients awaiting surgery', 'description': 'All patients will have both standard care and point-of-care (experimental) NP swabs performed.', 'interventionNames': ['Diagnostic Test: Spartan COVID-19 Platform']}, {'type': 'EXPERIMENTAL', 'label': 'Health Care Workers', 'description': 'Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed.', 'interventionNames': ['Diagnostic Test: Spartan COVID-19 Platform']}], 'interventions': [{'name': 'Spartan COVID-19 Platform', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform', 'armGroupLabels': ['Health Care Workers', 'Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission', 'patients awaiting surgery', 'patients undergoing cardiac testing/procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}