Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT04699903
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2020-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fingerstick whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR', 'timeFrame': '0-7 days', 'description': 'Determine PPA and NPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)'}, {'measure': 'PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR', 'timeFrame': '8-14 days', 'description': 'Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)'}, {'measure': 'PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR', 'timeFrame': '15 - 90 days', 'description': 'Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['IgG', 'Point of care testing', 'EUA'], 'conditions': ['SARS-Cov-2, Covid19']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.', 'detailedDescription': 'Patients with PCR testing in outpatient setting will be screened and asked to participate in the study.\n\nSubjects with a positive diagnosis of COVID-19 confirmed by a positive, EUA SARS-CoV-2 PCR test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or \\>15 days) in the positive cohort Subjects with a negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.\n\nTreating clinicians, clinical research coordinators and study subjects will be blinded to the POC test results.\n\nQuality assurance will be assured with site monitoring to check accuracy and completeness of data entered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the outpatient setting with EUA PCR test results who meet inclusion and exclusion criteria are eligible for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Positive Cohort\n\nInclusion Criteria:\n\n* Patients with high-sensitive EUA PCR results (positive result)\n* Previous diagnostic of SARS-Cov-2\n* Signed informed consent\n\nExclusion Criteria:\n\n* Missing PCR results\n* Results from a non-high-sensitive PCR test\n\nNegative Cohort\n\nInclusion Criteria:\n\n* Patients with high-sensitive EUA PCR results (negative result)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Missing PCR results\n* Results from a non-high-sensitive PCR test\n* Previous diagnostic of SARS-Cov-2\n* History of a positive SARS-CoV-2 antibody test (IgG, IgM or Total Antibody)\n* Negative SARS-Cov-2 PCR result that occurred \\> 7 days from study visit'}, 'identificationModule': {'nctId': 'NCT04699903', 'briefTitle': 'Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Diagnostics'}, 'officialTitle': 'Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 IgG Antibody Test in Fingerstick Whole Blood', 'orgStudyIdInfo': {'id': '20-1106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive SARS-Cov-2 cohort', 'description': 'Positive diagnosis of COVID-19 confirmed by a positive EUA SARS-CoV-2 PCR will be stratified in three subgroups 0 - 7 days since onset of symptoms 8 - 14 days since onset of symptoms 15 -90 days since onset of symptoms', 'interventionNames': ['Diagnostic Test: POC SARS-Cov-2 IgG Antibody test']}, {'label': 'Negative SARS-Cov-2 cohort', 'description': 'Negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.', 'interventionNames': ['Diagnostic Test: POC SARS-Cov-2 IgG Antibody test']}], 'interventions': [{'name': 'POC SARS-Cov-2 IgG Antibody test', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood', 'armGroupLabels': ['Negative SARS-Cov-2 cohort', 'Positive SARS-Cov-2 cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Benchmark - SoCal', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Clinical Research', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials (GLCT)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumos Diagnostics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rapid Pathogen Screening', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}