Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-28 @ 4:15 AM
Study NCT ID:
NCT05060250
Status:
UNKNOWN
Last Update Posted:
2023-08-15
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of IL-6 Concentration in Patients at High Risk of Severe Sepsis', 'timeFrame': 'Specimen is tested within 12 hours from collection', 'description': 'Determine the interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of septic shock.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Sepsis']}, 'descriptionModule': {'briefSummary': 'Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device.\n\nThis study is to establish an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will test 96 remnant, whole-blood specimens collected as baseline samples from confirmed COVID-19 patients at the University of Texas Southwestern Medical Center. Subjects will be symptomatic and have been confirmed by an emergency use authorized (EUA) real-time polymerase chain reaction (RT-PCR) test to be COVID-19 positive. The whole-blood specimens will have been submitted to the local laboratory for routine testing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Whole-blood specimen collected in K2 EDTA anticoagulant tubes\n* Subject is considered to have severe or critical illness per below:\n\nSevere Illness\n\n1. SpO2 \\< 94% on room air at sea level;\n2. Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \\< 300 mmHg;\n3. Respiratory frequency \\> 30 breaths/min;\n4. Or lung infiltrates \\>50% Critical Illness\n\na) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criterion of severe illness\n\n* Subject confirmed to be COVID-19 positive by an EUA RT-PCR test\n* Subject is 18+ years of age\n* Minimum volume of 100µL for Symphony IL-6 testing\n* Specimen is available for testing within 12 hours from collection\n\nExclusion Criteria:\n\n* Subject is receiving an anti-IL-6 treatment\n* Subject is receiving corticosteroids\n* Hemolyzed specimens'}, 'identificationModule': {'nctId': 'NCT05060250', 'briefTitle': 'Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bluejay Diagnostics, Inc.'}, 'officialTitle': 'Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis', 'orgStudyIdInfo': {'id': 'CES-0002'}}, 'contactsLocationsModule': {'locations': [{'zip': '01720', 'city': 'Acton', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.44681, 'lon': -97.6903}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bluejay Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}