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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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