Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
NCT ID: NCT06311435
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
224 participants
INTERVENTIONAL
2024-03-15
2026-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Participants never infected by SARS-COV-2
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.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with SARS-COV-2 post-infection without long COVID
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.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with long COVID and current/active respiratory symptoms
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.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with long COVID and current/active neurological symptoms
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.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants who have long COVID with current/active both respiratory and neurological symptoms
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.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants who have other current/active long COVID symptoms
Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection
Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019
Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection
Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection
Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with resolved long COVID respiratory symptoms
Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with resolved long COVID neurological symptoms
Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with resolved long COVID respiratory and neurological symptoms
Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Participants with other resolved long COVID symptoms
Participants with a history of SARS-COV-2 and other resolved long COVID symptoms
RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Interventions
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RNA Biomarker Blood Test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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MaxWell Clinic, PLC
INDUSTRY
Responsible Party
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Cale T Queen
Executive Director
Locations
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University of Iowa
Iowa City, Iowa, United States
The MaxWell Clinic
Brentwood, Tennessee, United States
The MaxWell Clinic
Brentwood, Tennessee, United States
Countries
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Facility Contacts
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Other Identifiers
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FBB-RNA-004
Identifier Type: -
Identifier Source: org_study_id
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