Long COVIDNCT06311435
Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
A study testing RNA Biomarker Blood Test in people with Long COVID, run by MaxWell Clinic, PLC at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- What is being tested?
- RNA Biomarker Blood Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Mar 2024to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
The MaxWell Clinic
Brentwood, Tennessee, 37027
Justin Davis, 615-370-0091, Justin@maxwellclinic.com
Cale T Queen, PhD, 16153700091, cale@maxwellclinic.com
- Recruiting
The MaxWell Clinic
Brentwood, Tennessee, 37027
Justin Davis, 615-370-0091, justin@maxwellclinic.com
Cale T Queen, PhD., 6153700091, cale@maxwellclinic.com
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Debra O'Connell-Moore, MBA, 319-356-1693, debra-oconnell-moore@uiowa.edu
Alejandro P Comellas, MD
About this study
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.
Read the 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.
- Conditions
- Long COVID
- Being tested
- RNA Biomarker Blood Test
- Keywords
- COVID-19, Long COVID, Long Haul COVID, Long COVID-19, Long Haul COVID-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA Biomarker Blood TestDiagnostic test
Blood will be collected into a PaxGene Blood tube for processing by sponsor
| Study group | Role | What they receive |
|---|---|---|
| Participants never infected by SARS-COV-2 | Active comparator | 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. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with SARS-COV-2 post-infection without long COVID | Active comparator | 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. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with long COVID and current/active respiratory symptoms | Active comparator | 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. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with long COVID and current/active neurological symptoms | Active comparator | 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. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants who have long COVID with current/active both respiratory and neurological symptoms | Active comparator | 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. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants who have other current/active long COVID symptoms | Active comparator | Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection | Active comparator | Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019 | Active comparator | Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection | Active comparator | Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019. Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection | Active comparator | Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with resolved long COVID respiratory symptoms | Active comparator | Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with resolved long COVID neurological symptoms | Active comparator | Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with resolved long COVID respiratory and neurological symptoms | Active comparator | Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms Receives: Diagnostic Test: RNA Biomarker Blood Test |
| Participants with other resolved long COVID symptoms | Active comparator | Participants with a history of SARS-COV-2 and other resolved long COVID symptoms Receives: Diagnostic Test: RNA Biomarker Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop algorithm to classify RNA sequences to identify long COVID
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
Measured: 30 days
Secondary outcomes (1)
Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID
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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2024
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaxWell Clinic, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Cale T Queen, MaxWell Clinic, PLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311435
- Sponsor's protocol ID
- FBB-RNA-004
- Status last verified
- Oct 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results will be published if the hypothesis is supported.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
- ClinicalTrials.gov ID
- NCT06311435
- Acronym / sponsor ID
- FBB-RNA-004
- Conditions
- Long COVID
- Keywords
- COVID-19, Long COVID, Long Haul COVID, Long COVID-19, Long Haul COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- MaxWell Clinic, PLCIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 14
- Model description
- Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.
| Arm | Type | Receives |
|---|---|---|
| Participants never infected by SARS-COV-2 | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants 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. |
| Participants with SARS-COV-2 post-infection without long COVID | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants 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. |
| Participants with long COVID and current/active respiratory symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants 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. |
| Participants with long COVID and current/active neurological symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants 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. |
| Participants who have long COVID with current/active both respiratory and neurological symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants 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. |
| Participants who have other current/active long COVID symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions. |
| Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019. |
| Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019 | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019. |
| Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019. |
| Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection |
| Participants with resolved long COVID respiratory symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved |
| Participants with resolved long COVID neurological symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms |
| Participants with resolved long COVID respiratory and neurological symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms |
| Participants with other resolved long COVID symptoms | Active comparator | Diagnostic Test: RNA Biomarker Blood TestParticipants with a history of SARS-COV-2 and other resolved long COVID symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA Biomarker Blood TestBlood will be collected into a PaxGene Blood tube for processing by sponsor | Diagnostic test | Participants never infected by SARS-COV-2, Participants who have long COVID with current/active both respiratory and neurological symptoms, Participants who have other current/active long COVID symptoms, Participants with SARS-COV-2 post-infection without long COVID, Participants with long COVID and current/active neurological symptoms, Participants with long COVID and current/active respiratory symptoms, Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection, Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection, Participants with other resolved long COVID symptoms, Participants with resolved long COVID neurological symptoms, Participants with resolved long COVID respiratory and neurological symptoms, Participants with resolved long COVID respiratory symptoms, Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019, Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection |
Primary outcome
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
1 secondary outcome
Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID
Time frame: 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Undecided. The results will be published if the hypothesis is supported.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RNA Biomarker Blood Test in people with Long COVID, run by MaxWell Clinic, PLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop algorithm to classify RNA sequences to identify long COVID (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.