Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05596032
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2022-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'The purpose of this work is to carry out a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for the antigenic determination of the SARS-CoV-2 virus on the abioSCOPE instrument.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument.\n\nThe objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test:\n\n1. shows sensitivity:\n\n * ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or\n * ≥ 90% for subjects with Ct ≤ 25.\n2. show ≥ 98% specificity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes unselected participants\\*, symptomatic, asymptomatic having had close contact with positive patients, and asymptomatic with no known exposure to SARS-CoV-2.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* provide valid informed consent before taking the tests;\n* in the case of symptomatic patients, be tested within the first seven days after the onset of symptoms.\n* Male or female, aged equal to or older than 18 years of age.\n\nExclusion Criteria:\n\n* Symptomatic participants who take the test after seven days after the onset of symptoms are excluded from the study'}, 'identificationModule': {'nctId': 'NCT05596032', 'briefTitle': 'Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abionic SA'}, 'officialTitle': 'Prospective Field Study to Validate the Diagnostic Performance of the IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2 on abioSCOPE®', 'orgStudyIdInfo': {'id': 'AB-COV-003'}}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'A.O Mauriziano di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abionic SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}