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

March 14, 2024 updated by: Cale T Queen, MaxWell Clinic, PLC
The primary objective of this study is to determine, in unblinded samples, whether artificial intelligence can classify specific blood RNA from patients with long COVID together and separately from apparently healthy normals and other medical conditions which share signs and symptoms of long COVID.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be screened and provide two blood samples 30 (+/- 5) days apart. Based on the participants survey results they will be placed into one of eleven groups that reflect the type of Long COVID the patient is experiencing. Samples will be shipped to the sponsor who will attempt to use AI processes 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 Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Recruiting
        • The MaxWell Clinic
        • Contact:
        • Principal Investigator:
          • David H Haase, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Hemasure 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Participants with long COVID and 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Participants with long COVID and 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Participants who have long COVID with 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Participants who have other long COVID symptoms
Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Participants with neurological symptoms prior to 1 November 2019
Participants with a history of SARS-COV-2 infection who had neurologic symptoms prior to 1 November 2019. 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Participants with respiratory symptoms prior to 1 November 2019
Participants with a history of SARS-COV-2 infection who had respiratory symptoms prior to 1 November 2019. 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Neurological symptoms prior to 1 November 2019 without history of SARS-COV-2 infection
Participants without a history of SARS-COV-2 infection who had neurologic symptoms prior to 1 November 2019. 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Respiratory symptoms prior to 1 November 2019 without history of SARS-COV-2 infection
Participants without a history of SARS-COV-2 infection who had respiratory symptoms prior to 1 November 2019. 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 Hemasure Blood tube for processing by sponsor
Active Comparator: Participants who do not meet long COVID criteria but are otherwise unclassified
Participants with a history of SARS-COV-2 infection who do not have signs of Long COVID but do not fit into other arms.
Diagnostic test: RNA Biomarker Blood Test
Blood will be collected into a Hemasure Blood tube for processing by sponsor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Artificial Intelligence Identified number of RNA Biomarkers for Long COVID
Time Frame: 30 days
The primary objective of this study is to determine, in unblinded samples, whether artificial intelligence can classify specific blood RNA from patients with long COVID together and separately from apparently healthy normals and other medical conditions which share signs and symptoms of long COVID.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Artificial Intelligence Identified number of RNA Biomarkers for specific Long COVID subgroups
Time Frame: 30 Days
The secondary objective of the study is to determine if artificial intelligence can subclassify specific blood RNA biomarkers long COVID patients into various symptom-related subcategories to provide clinically relevant treatment options.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MaxWell Clinic, PLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBB-RNA-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The results will be published if the hypothesis is supported.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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