Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT05227404
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2022-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Point-of-Care (EPOC) for COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edenning@umn.edu', 'phone': '612-626-8049', 'title': 'Eileen Denning', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'adverse events were not collected', 'description': 'Adverse events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay\n\nLumiraDX: Point-of-care test for SARS-CoV-2\n\nRightSign: Point-of-care test for SARS-CoV-2\n\nCase Control: Genscript assay performed on the plasma sample', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Test Results Comparison Between LumiraDx and GenScript', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay\n\nLumiraDX: Point-of-care test for SARS-CoV-2\n\nRightSign: Point-of-care test for SARS-CoV-2\n\nCase Control: Genscript assay performed on the plasma sample'}], 'classes': [{'categories': [{'measurements': [{'value': '0.097', 'groupId': 'OG000', 'lowerLimit': '0.059', 'upperLimit': '0.135'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an average of 1 day', 'description': "LumiraDx test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.", 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of Results Obtained by RightSign and GenScript', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay\n\nLumiraDX: Point-of-care test for SARS-CoV-2\n\nRightSign: Point-of-care test for SARS-CoV-2\n\nCase Control: Genscript assay performed on the plasma sample'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.038', 'groupId': 'OG000', 'lowerLimit': '-0.074', 'upperLimit': '-0.001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an average of 1 day', 'description': "RightSign test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.", 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LumiraDx Valid Test Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay\n\nLumiraDX: Point-of-care test for SARS-CoV-2\n\nRightSign: Point-of-care test for SARS-CoV-2\n\nCase Control: Genscript assay performed on the plasma sample'}], 'classes': [{'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 1 day', 'description': 'The frequency with which the LumiraDx test fails to give an unambiguous result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'RightSign Valid Test Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay\n\nLumiraDX: Point-of-care test for SARS-CoV-2\n\nRightSign: Point-of-care test for SARS-CoV-2\n\nCase Control: Genscript assay performed on the plasma sample'}], 'classes': [{'categories': [{'measurements': [{'value': '327', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 1 day', 'description': 'The frequency with wich the RightSign test fails to give an unambiguous result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay\n\nLumiraDX: Point-of-care test for SARS-CoV-2\n\nRightSign: Point-of-care test for SARS-CoV-2\n\nCase Control: Genscript assay performed on the plasma sample'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay\n\nLumiraDX: Point-of-care test for SARS-CoV-2\n\nRightSign: Point-of-care test for SARS-CoV-2\n\nCase Control: Genscript assay performed on the plasma sample'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '148', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '177', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '221', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-26', 'size': 1572926, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-05-16T18:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2022-01-26', 'resultsFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test Results Comparison Between LumiraDx and GenScript', 'timeFrame': 'an average of 1 day', 'description': "LumiraDx test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless."}, {'measure': 'Comparison of Results Obtained by RightSign and GenScript', 'timeFrame': 'an average of 1 day', 'description': "RightSign test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless."}], 'secondaryOutcomes': [{'measure': 'LumiraDx Valid Test Frequency', 'timeFrame': 'an average of 1 day', 'description': 'The frequency with which the LumiraDx test fails to give an unambiguous result'}, {'measure': 'RightSign Valid Test Frequency', 'timeFrame': 'an average of 1 day', 'description': 'The frequency with wich the RightSign test fails to give an unambiguous result'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS COV 2', 'COVID19 testing'], 'conditions': ['COVID-19', 'SARS CoV 2 Infection']}, 'referencesModule': {'references': [{'pmid': '39269490', 'type': 'DERIVED', 'citation': 'Reilly C, Mylonakis E, Dewar R, Young B, Nordwall J, Bhagani S, Chia PY, Davis R, Files C, Ginde AA, Hatlen T, Helleberg M, Hayanga A, Jensen TO, Jain MK, Kalomenidis I, Kim K, Lallemand P, Lindegaard B, Menon A, Ognenovska K, Poulakou G, Thorup Roge B, Rogers AJ, Shaw-Saliba K, Sandkovsky U, Trautner BW, Vasudeva SS, Vekstein A, Viens K, Wyncoll J, DuChateau B, Zhang Z, Wu S, Babiker AG, Davey V, Gelijns A, Higgs E, Kan V, Lundgren J, Matthews GV, Lane HC. Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019. J Infect Dis. 2025 Mar 17;231(3):677-683. doi: 10.1093/infdis/jiae452.'}]}, 'descriptionModule': {'briefSummary': 'EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults hospitalized with COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.\n* SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)\n* Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.\n* Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.\n\nExclusion Criteria:\n\n* Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.\n* Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:\n\n 1. stroke\n 2. meningitis\n 3. encephalitis\n 4. myelitis\n 5. myocardial infarction\n 6. myocarditis\n 7. pericarditis\n 8. symptomatic congestive heart failure (CHF; New York Heart Association \\[NYHA\\] class III-IV)\n 9. arterial or deep venous thrombosis or pulmonary embolism\n* Current requirement for any of the following:\n\n 1. high-flow supplemental oxygen\n 2. non-invasive ventilation\n 3. invasive mechanical ventilation\n 4. extracorporeal membrane oxygenation\n 5. mechanical circulatory support\n 6. vasopressor therapy\n 7. commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).\n* In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments."}, 'identificationModule': {'nctId': 'NCT05227404', 'acronym': '(EPOC)', 'briefTitle': 'Evaluation of Point-of-Care (EPOC) for COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)', 'orgStudyIdInfo': {'id': 'STUDY00014758'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID19 Assays', 'description': 'All participants enrolled will receive 2 point of care assays, and 1 central lab assay', 'interventionNames': ['Diagnostic Test: LumiraDX', 'Diagnostic Test: RightSign', 'Diagnostic Test: Case Control']}], 'interventions': [{'name': 'LumiraDX', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-care test for SARS-CoV-2', 'armGroupLabels': ['COVID19 Assays']}, {'name': 'RightSign', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-care test for SARS-CoV-2', 'armGroupLabels': ['COVID19 Assays']}, {'name': 'Case Control', 'type': 'DIAGNOSTIC_TEST', 'description': 'Genscript assay performed on the plasma sample', 'armGroupLabels': ['COVID19 Assays']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}