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

October 16, 2024 updated by: Cale T Queen, MaxWell Clinic, PLC
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

224

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
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Contact:
        • Sub-Investigator:
          • Alejandro P Comellas, MD
    • 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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID
Time Frame: 30 Days
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.
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 (Actual)

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)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 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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