Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 7:07 AM
Study NCT ID:
NCT04372004
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
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': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection of viral infection using serology and viral-RNA detection kits', 'timeFrame': '1 day', 'description': 'Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection'}], 'secondaryOutcomes': [{'measure': 'Temporal trend of antibodies in blood', 'timeFrame': '1 month', 'description': 'Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.', 'detailedDescription': 'The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Male or female over 18 years of age at the time of enrollment\n\n * Current symptoms of COVID-19 ; fever alone or fever and at least one of the following symptoms need to be present\n\n * Dry cough\n * Sore throat\n * Shortness of breath\n * Chills\n * Muscle pain\n * Headache\n * New loss of taste or smell\n * Chills with repeated shaking\n\nExclusion Criteria:\n\n* • Unwilling to provide informed consent\n\n * Unwilling to undergo bi-weekly serological test during the 1-month enrollment'}, 'identificationModule': {'nctId': 'NCT04372004', 'acronym': 'CATCH COVID-19', 'briefTitle': 'Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'Texas Cardiac Arrhythmia Research Foundation'}, 'officialTitle': 'Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)', 'orgStudyIdInfo': {'id': 'TCAI_CATCH COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Viral RNA test using nasopharyngeal swab', 'interventionNames': ['Diagnostic Test: diagnostic tests for COVID-19 infection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Viral RNA test using sputum', 'interventionNames': ['Diagnostic Test: diagnostic tests for COVID-19 infection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Serology test using blood', 'interventionNames': ['Diagnostic Test: diagnostic tests for COVID-19 infection']}], 'interventions': [{'name': 'diagnostic tests for COVID-19 infection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA', 'armGroupLabels': ['Serology test using blood', 'Viral RNA test using nasopharyngeal swab', 'Viral RNA test using sputum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitra Mohanty, MD', 'role': 'CONTACT', 'email': 'mitra1989@gmail.com', 'phone': '512-544-8186'}, {'name': 'Angel Mayedo, MD', 'role': 'CONTACT', 'phone': '5125447254'}], 'facility': 'Texas Cardiac Arrhythmia Institute', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'MITRA Mohanty, MD', 'role': 'CONTACT', 'email': 'mitra1989@gmail.com', 'phone': '5127842651'}, {'name': 'Deb Cardinal, RN MBA', 'role': 'CONTACT', 'phone': '512) 807-3150'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Cardiac Arrhythmia Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Medical Director', 'investigatorFullName': 'Andrea Natale', 'investigatorAffiliation': 'Texas Cardiac Arrhythmia Research Foundation'}}}}