Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04987918
Status:
UNKNOWN
Last Update Posted:
2022-08-10
First Post:
2021-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gazelle COVID-19 Test Clinical Accuracy Protocol
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2021-07-30', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) will be measured', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive subjects of all ages who visit the facility for covid 19 testing (symptomatic and asymptomatic).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Symptomatic study:\n\nInclusion Criteria:\n\nThe presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms include:\n\n* Fever\n* Coughing\n* Shortness of breath\n* Recent loss of sense of smell or taste\n* Chills\n* Repeated shaking with chills\n* Muscle pain\n* Headache\n* Sore throat\n* Vomiting or diarrhea\n\n * Within 1-5 days of symptom onset\n * Informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor\n * All ages\n * All genders\n * Pregnant women\n\nExclusion Criteria:\n\n* Severe disease requiring immediate medical intervention\n* Inability to tolerate sampling procedure (nasal swab)\n* Failure to provide informed consent\n* Nasal deformities preventing sampling by swab\n* Ongoing nosebleeds or use of a nasal spray within the last 4 hours.\n* Asymptomatic patients\n\nAsymptomatic study:\n\nInclusion criteria:\n\n* Present to the facility for a COVID-19 test without symptoms\n* Informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor\n\nExclusion Criteria:\n\nExclusion criteria include one or more of the following:\n\n* Severe disease requiring immediate medical intervention\n* Inability to tolerate sampling procedure\n* Is below 2 years old\n* Failure to provide informed consent\n* Nasal deformities preventing sampling by swab\n* Ongoing nosebleeds or use of a nasal spray within the last 4 hours.\n* Presence of typical symptoms of COVID-19 (fever, sore throat, fatigue, etc.)'}, 'identificationModule': {'nctId': 'NCT04987918', 'briefTitle': 'Gazelle COVID-19 Test Clinical Accuracy Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hemex Health'}, 'officialTitle': 'Gazelle COVID-19 Test Clinical Accuracy Protocol', 'orgStudyIdInfo': {'id': 'GZL-FC10-PTL-0001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Applied Biosystems TaqPath COVID- 19 Combo Kit', 'type': 'DIAGNOSTIC_TEST', 'description': 'Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98226', 'city': 'Bellingham', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bri Spencer', 'role': 'CONTACT', 'email': 'Bri.Spencer@nwlaboratory.com'}], 'facility': 'Northwest Pathology drive thru site, Bellingham International Airport', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}], 'centralContacts': [{'name': 'PRIYA THOTA, MD', 'role': 'CONTACT', 'email': 'p.thota@hemexhealth.com', 'phone': '2162339405'}, {'name': 'David Bell, MD', 'role': 'CONTACT', 'email': 'd.bell@hemexhealth.com'}], 'overallOfficials': [{'name': 'Ryan Robert Fortna, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest Pathology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hemex Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}