Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19

Purpose

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.

Condition

  • Long COVID

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.
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.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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.
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
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
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
Participants with resolved long COVID respiratory symptoms 		Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
Participants with resolved long COVID neurological symptoms 		Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
Participants with resolved long COVID respiratory and neurological symptoms 		Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor
Active Comparator
Participants with other resolved long COVID symptoms 		Participants with a history of SARS-COV-2 and other resolved long COVID symptoms
  • Diagnostic Test: RNA Biomarker Blood Test
    Blood will be collected into a PaxGene Blood tube for processing by sponsor

Recruiting Locations

The MaxWell Clinic
Brentwood, Tennessee 37027
Contact:
Justin Davis
615-370-0091
Justin@maxwellclinic.com

The MaxWell Clinic
Brentwood, Tennessee 37027
Contact:
Justin Davis
615-370-0091
justin@maxwellclinic.com

More Details

NCT ID
NCT06311435
Status
Recruiting
Sponsor
MaxWell Clinic, PLC

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.