Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-28 @ 10:51 PM
Study NCT ID:
NCT06311435
Status:
RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'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'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will be assigned a random number from the electronic health record. The only information shared with the sponsor will be Pt ID number, age, gender and state of residence.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-14', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Develop algorithm to classify RNA sequences to identify long COVID', 'timeFrame': '30 days', 'description': 'The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID'}], 'secondaryOutcomes': [{'measure': 'Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID', 'timeFrame': '30 Days', 'description': 'The secondary objective of this study is to determine if it is possible to develop an algorithm that can subclassify specific blood RNA biomarkers in long COVID patients into various symptom-related subcategories to provide clinically relevant treatment options.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Long COVID', 'Long Haul COVID', 'Long COVID-19', 'Long Haul COVID-19'], 'conditions': ['Long COVID']}, 'descriptionModule': {'briefSummary': 'The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID.', 'detailedDescription': 'Participants will be screened and provide two blood samples28 (+/- 2) days apart. Based on the participants survey results they will be placed into one of fourteen groups that reflect the type of Long COVID the patient is experiencing. Samples will be shipped to the sponsor who will develop an AI process to validate the type of Long COVID and assess its severity. The long term goal is to develop a reliable test to identify the presence of Long COVID and its severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mentally capable of understanding and completing informed consent for the study.\n* Precipitants with a lab verified diagnosis of SARS-CoV-2 or clinician note/record that an appropriate rapid test for SARS-CoV-2 was positive.\n* To qualify for long COVID group participants will need to have new, persistent symptoms related to SARS-CoV-2 infection. iv. No one under the age of 18.\n\nExclusion Criteria:\n\n* Subject is unable to provide informed consent.\n* Primary Investigator or Sub-Investigator determines the participant's ongoing medical complaints that began after 1 November 2019 are not related to SARS-COV-2 but another disease process."}, 'identificationModule': {'nctId': 'NCT06311435', 'briefTitle': 'Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'MaxWell Clinic, PLC'}, 'officialTitle': 'Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19', 'orgStudyIdInfo': {'id': 'FBB-RNA-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Participants never infected by SARS-COV-2', 'description': 'Participants with no history of SARS-COV-2 infection. This is a control arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with SARS-COV-2 post-infection without long COVID', 'description': 'Participants with a history of SARS-COV-2 infection, but never developed long term sequalae. This is a control arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with long COVID and current/active respiratory symptoms', 'description': 'Participants with a history of SARS-COV-2 infection and developed long term sequalae associated with their respiratory system: continued shortness of breath, etc.. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with long COVID and current/active neurological symptoms', 'description': 'Participants with a history of SARS-COV-2 infection and developed long term sequalae associated with their neurologic system: brain fog, confusion, etc.. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants who have long COVID with current/active both respiratory and neurological symptoms', 'description': 'Participants with a history of SARS-COV-2 infection and developed long term sequalae associated with both their respiratory system and their neurologic system. This is an experimental arm of the study. Participants will complete an ethnic survey, medical history survey and undergo two blood draws.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants who have other current/active long COVID symptoms', 'description': 'Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection', 'description': 'Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019', 'description': 'Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection', 'description': 'Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection', 'description': 'Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with resolved long COVID respiratory symptoms', 'description': 'Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with resolved long COVID neurological symptoms', 'description': 'Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with resolved long COVID respiratory and neurological symptoms', 'description': 'Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants with other resolved long COVID symptoms', 'description': 'Participants with a history of SARS-COV-2 and other resolved long COVID symptoms', 'interventionNames': ['Diagnostic Test: RNA Biomarker Blood Test']}], 'interventions': [{'name': 'RNA Biomarker Blood Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood will be collected into a PaxGene Blood tube for processing by sponsor', 'armGroupLabels': ['Participants never infected by SARS-COV-2', 'Participants who have long COVID with current/active both respiratory and neurological symptoms', 'Participants who have other current/active long COVID symptoms', 'Participants with SARS-COV-2 post-infection without long COVID', 'Participants with long COVID and current/active neurological symptoms', 'Participants with long COVID and current/active respiratory symptoms', 'Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection', 'Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection', 'Participants with other resolved long COVID symptoms', 'Participants with resolved long COVID neurological symptoms', 'Participants with resolved long COVID respiratory and neurological symptoms', 'Participants with resolved long COVID respiratory symptoms', 'Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019', 'Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': "Debra O'Connell-Moore, MBA", 'role': 'CONTACT', 'email': 'debra-oconnell-moore@uiowa.edu', 'phone': '319-356-1693'}, {'name': 'Alejandro P Comellas, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin Davis', 'role': 'CONTACT', 'email': 'Justin@maxwellclinic.com', 'phone': '615-370-0091'}, {'name': 'Cale T Queen, PhD', 'role': 'CONTACT', 'email': 'cale@maxwellclinic.com', 'phone': '16153700091'}, {'name': 'David H Haase, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The MaxWell Clinic', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin Davis', 'role': 'CONTACT', 'email': 'justin@maxwellclinic.com', 'phone': '615-370-0091'}, {'name': 'Cale T Queen, PhD.', 'role': 'CONTACT', 'email': 'cale@maxwellclinic.com', 'phone': '6153700091'}, {'name': 'David H Haase, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The MaxWell Clinic', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The results will be published if the hypothesis is supported.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaxWell Clinic, PLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Director', 'investigatorFullName': 'Cale T Queen', 'investigatorAffiliation': 'MaxWell Clinic, PLC'}}}}