Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 9:58 PM
Study NCT ID:
NCT04625257
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2020-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-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': 'D000917', 'term': 'Antibody Formation'}], 'ancestors': [{'id': 'D007110', 'term': 'Immunity, Active'}, {'id': 'D056704', 'term': 'Adaptive Immunity'}, {'id': 'D007109', 'term': 'Immunity'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biological material is appropriately stored in a restricted area only accessible to authorized personnel. Until completion of the study, the material will be stored in the biobank "SERO-BL-COVID-19".'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection)', 'timeFrame': 'single point assessment at baseline', 'description': 'For all qualitative method validation, the qualitative and quantitative result of the Foederatio Analyticorum Medicinalium Helveticorum (FAMH) performed RT-PCR (patient does / does not have SARS-Cov-2 and if yes, how many "ct" values for detection) is considered as the gold standard against which the crude extraction in combination with the LAMP or the NGS method using univariate measures is compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)', 'quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay', 'point of care tests (POCT)', 'next-generation sequencing (NGS) method', 'contact tracing', 'transmission chains', 'crude RNA extraction from saliva', 'loop mediated amplification (LAMP) assay', 'viral nucleic acid analysis platform'], 'conditions': ['Coronavirus Infectious Disease 2019 (COVID-19)']}, 'descriptionModule': {'briefSummary': "This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Symptomatic patients arriving at the COVID-19 test center Feldreben in Muttenz, Basel Land and at Swiss TPH in Basel, Basel Stadt to get tested for COVID-19.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic patients getting tested for COVID-19\n\nExclusion Criteria:\n\n* mentally incompetent adults'}, 'identificationModule': {'nctId': 'NCT04625257', 'briefTitle': 'COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)', 'orgStudyIdInfo': {'id': '2020-01112; ch20Savic2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Saliva based assay: crude RNA extraction', 'type': 'OTHER', 'description': "Crude RNA extraction to inactivate the virus and stabilize the RNA for transport at room temperature. Validation of the crude RNA extraction from saliva in combination with NGS diagnostics and LAMP assays and point of care test (POCT) for rapid detection of viral antigens on patients' samples."}, {'name': 'Validation of the NGS method', 'type': 'OTHER', 'description': 'Compare the results obtained with the next-generation sequencing (NGS) method to the nasopharyngeal swabs analysed in a FAMH certified lab.'}, {'name': 'Validation of the LAMP assays', 'type': 'OTHER', 'description': 'The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay.'}, {'name': 'Validation of the POCT Antigen and Antibody tests', 'type': 'OTHER', 'description': "Rapid point of care tests (POCT) detecting viral protein antigens (Ag) and antibodies (Ab) on patients' samples. POCT are often employed in low income countries, but for COVID-19 they are not yet characterized. Their performance is to be characterized that they can be used as a safe guard if the lab diagnostics fail."}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Miodrag Savic, Dr. med. Dr. med. dent.', 'role': 'CONTACT', 'email': 'miodrag.savic@usb.ch', 'phone': '+41 79 485 31 13'}], 'facility': 'Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'centralContacts': [{'name': 'Miodrag Savic, Dr. med. Dr. med. dent.', 'role': 'CONTACT', 'email': 'miodrag.savic@usb.ch', 'phone': '+41 79 485 31 13'}, {'name': 'Juerg Sommer, Dr.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Miodrag Savic, Dr. med. Dr. med. dent.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'ETH Zurich Department for Biosystems, Science and Engineering', 'class': 'UNKNOWN'}, {'name': 'Kanton Basel- Landschaft', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}