Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 224
- Locations
- 4
- Primary Endpoint
- Develop algorithm to classify RNA sequences to identify long COVID
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Mentally capable of understanding and completing informed consent for the study.
- •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
- •Subject is unable to provide informed consent.
- •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.
Arms & Interventions
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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.
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
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
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
Participants with resolved long COVID respiratory symptoms
Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
Participants with resolved long COVID neurological symptoms
Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
Participants with resolved long COVID respiratory and neurological symptoms
Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
Participants with other resolved long COVID symptoms
Participants with a history of SARS-COV-2 and other resolved long COVID symptoms
Intervention: RNA Biomarker Blood Test (Diagnostic Test)
Outcomes
Primary Outcomes
Develop algorithm to classify RNA sequences to identify long COVID
Time Frame: 30 days
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
Secondary Outcomes
- Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID(30 Days)
Investigators
Cale T Queen
Executive Director
MaxWell Clinic, PLC