Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-04-23 @ 3:41 AM
Study NCT ID:
NCT04408066
Status:
SUSPENDED
Last Update Posted:
2024-01-12
First Post:
2020-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19: A POC Test Under Research & Evaluation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Sample Collection \\& Performance Evaluation Study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'whyStopped': 'Number of required participants met', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.', 'timeFrame': '1 Year approx', 'description': 'Primary Outcome - To collect sufficient SARS-CoV-2 samples (nasal/nasopharyngeal/throat swabs and blood samples) to aid development, calibration and performance evaluation of the LumiraDx POC test. Results will be used to asses performance of the LumiraDx assay versus reference methods with regards to the clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['POC', 'IVD', 'SARS-CoV-2', 'IgG', 'IgM', 'Antigen', 'Antibody'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.', 'detailedDescription': 'CAPTURE is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is split into two arms targeting separate populations throughout each stage.\n\nStage 1: Consists of sample collection only, to facilitate the in-house development and calibration of the LumiraDx SARS-CoV-2 assays.\n\nStage 2: Consists of sample collection to facilitate the performance evaluation of the LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the LumiraDx POC device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is at least 18 years of age.\n2. Patient meets either of the below categories:\n\n 1. Patient is presenting with symptoms indicative of COVID-19 and will be completing SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A)\n 2. Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B)\n\nExclusion Criteria:\n\n1. The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable).\n2. The patient is deemed to be unsuitable for research at the research teams' discretion."}, 'identificationModule': {'nctId': 'NCT04408066', 'acronym': 'CAPTURE', 'briefTitle': 'COVID-19: A POC Test Under Research & Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'LumiraDx UK Limited'}, 'officialTitle': 'Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM & Antigen to be Used as an Aid in Diagnosis of COVID-19', 'orgStudyIdInfo': {'id': 'S-CLIN-PROT-00028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A:Suspected COVID-19 patients', 'description': 'Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM', 'interventionNames': ['Diagnostic Test: Sample Collection/Performance Evaluation (A)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Previously positive COVID-19 patients', 'description': 'Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2.', 'interventionNames': ['Diagnostic Test: Sample Collection/Performance Evaluation (B)']}], 'interventions': [{'name': 'Sample Collection/Performance Evaluation (A)', 'type': 'DIAGNOSTIC_TEST', 'description': 'This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.\n\nSample types include:\n\n* Nasal/Throat/Nasal Throat Combo/ Nasopharyngeal (as per sites SOC) Swab\n* Whole Venous Blood', 'armGroupLabels': ['Arm A:Suspected COVID-19 patients']}, {'name': 'Sample Collection/Performance Evaluation (B)', 'type': 'DIAGNOSTIC_TEST', 'description': 'This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.\n\nSample types include:\n\n* Whole Venous Blood\n* Fingerstick Capillary Sample', 'armGroupLabels': ['Arm B: Previously positive COVID-19 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'E9 6SR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Homerton University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Samer Elkhodair', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College London Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LumiraDx UK Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}