RNA Biomarker Blood Test for Post-COVID Syndrome

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: MaxWell Clinic, PLC

Disqualifiers: Under 18, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the RNA Biomarker Blood Test treatment for Post-COVID Syndrome?

Research shows that certain blood biomarkers, like C-reactive protein and interleukin-6, are higher in people with long COVID, suggesting these tests might help identify and understand the condition better. ^{1 2 3 4 5}

How is the RNA Biomarker Blood Test treatment different from other treatments for post-COVID syndrome?

The RNA Biomarker Blood Test is unique because it focuses on detecting specific RNA markers in the blood to diagnose and predict post-COVID syndrome, rather than treating symptoms directly. This approach is novel as it aims to identify the presence of viral RNA in the blood, which has been associated with ongoing symptoms, providing a potential diagnostic tool rather than a traditional treatment. ^{1 3 4 6 7}

Research Team

Eligibility Criteria

This trial is for individuals who have long COVID symptoms. It's designed to see if a blood test can identify unique RNA markers of the condition. Participants should be those experiencing long COVID or with similar symptoms due to other conditions.

Inclusion Criteria

I understand the study and can agree to participate.

I am 18 years old or older.

Participants with a lab-verified diagnosis of SARS-CoV-2 or clinician note/record that an appropriate rapid test for SARS-CoV-2 was positive

Exclusion Criteria

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

I am unable to understand and give consent for my treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Sample Collection

Participants provide two blood samples 28 (+/- 2) days apart for RNA analysis

4 weeks

2 visits (in-person)

Data Analysis

Blood samples are analyzed to develop an algorithm for classifying RNA sequences related to Long COVID

4 weeks

Follow-up

Participants are monitored for any additional data collection or survey completion

4 weeks

Treatment Details

Interventions

• RNA Biomarker Blood Test (Artificial Intelligence)

Trial Overview The study is testing whether an AI-driven blood test that looks at RNA biomarkers can accurately distinguish between long COVID and other illnesses with similar symptoms, as well as healthy individuals.

Participant Groups

Group I: Participants never infected by SARS-COV-2 Active Control 1 Intervention

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.

Group II: Participants with SARS-COV-2 post-infection without long COVID Active Control 1 Intervention

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.

Group III: Participants with long COVID and current/active respiratory symptoms Active Control 1 Intervention

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.

Group IV: Participants with long COVID and current/active neurological symptoms Active Control 1 Intervention

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.

Group V: Participants who have long COVID with current/active both respiratory and neurological symptoms Active Control 1 Intervention

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.

Group VI: Participants who have other current/active long COVID symptoms Active Control 1 Intervention

Participants with a history of SARS-COV-2 infection and developed long term sequalae not associated with respiratory or neurological conditions.

Group VII: Participants with neurological symptoms prior to 1 November 2019 without SARS-COV-2 infection Active Control 1 Intervention

Participants without a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.

Group VIII: Participants with respiratory symptoms before 1 November 2019 w/o SARS-COV-2 prior to 1 Nov 2019 Active Control 1 Intervention

Participants without a history of SARS-COV-2 infection and had respiratory conditions prior to 1 November 2019.

Group IX: Participants with neurological symptoms prior to 1 November 2019 with SARS-COV-2 infection Active Control 1 Intervention

Participants with a history of SARS-COV-2 infection and had neurological conditions prior to 1 November 2019.

Group X: Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection Active Control 1 Intervention

Participants with respiratory symptoms prior to 1 November 2019 with SARS-COV-2 infection

Group XI: Participants with resolved long COVID respiratory symptoms Active Control 1 Intervention

Participants with a history of SARS-COV-2 infection and long term respiratory symptoms that have resolved

Group XII: Participants with resolved long COVID neurological symptoms Active Control 1 Intervention

Participants with a history of SARS-COV-2 infection and resolved long COVID neurological symptoms

Group XIII: Participants with resolved long COVID respiratory and neurological symptoms Active Control 1 Intervention

Participants with history of SARS-COV-2 and resolved long COVID respiratory and neurological symptoms

Group XIV: Participants with other resolved long COVID symptoms Active Control 1 Intervention

Participants with a history of SARS-COV-2 and other resolved long COVID symptoms

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Iowa Iowa City, IA

The MaxWell Clinic Brentwood, TN

Who Is Running the Clinical Trial?

MaxWell Clinic, PLC

Lead Sponsor

Trials

2

Patients Recruited

270+

Findings from Research

In a study analyzing blood samples from post-COVID-19 patients, higher levels of IL-1α and TGF-β, along with lower levels of IFN-β, were identified as potential biomarkers that could predict the risk of developing pulmonary fibrosis, with a relative risk of 2.8.

The research highlighted that inflammatory markers like C reactive protein (CRP) and complement complex C5b-9 were elevated in post-COVID-19 patients, regardless of disease severity, indicating a persistent inflammatory response even after the acute phase of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-COVID-19 Patients Who Develop Lung Fibrotic-like Changes Have Lower Circulating Levels of IFN-β but Higher Levels of IL-1α and TGF-β. Colarusso, C., Maglio, A., Terlizzi, M., et al.[2021]

A study identified 119 blood proteins that can effectively differentiate Long-COVID patients from healthy individuals and COVID-19 inpatients, using advanced machine learning techniques on a case-control group.

Two optimal models were developed, each containing nine and five proteins, which demonstrated perfect accuracy in diagnosing Long-COVID, highlighting the potential for these biomarkers in targeted treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organ and cell-specific biomarkers of Long-COVID identified with targeted proteomics and machine learning. Patel, MA., Knauer, MJ., Nicholson, M., et al.[2023]

In a study analyzing plasma samples from patients with postacute sequelae of coronavirus disease 2019 (PASC), SARS-CoV-2 spike proteins were predominantly found in PASC patients, indicating a potential biomarker for this condition.

The presence of viral antigens was detected in PASC patients up to 12 months after their initial COVID-19 diagnosis, suggesting a prolonged impact of the virus on the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent Circulating Severe Acute Respiratory Syndrome Coronavirus 2 Spike Is Associated With Post-acute Coronavirus Disease 2019 Sequelae. Swank, Z., Senussi, Y., Manickas-Hill, Z., et al.[2023]

A systematic review identified 113 blood biomarkers associated with long COVID symptoms, with 79 biomarkers elevated in long COVID patients compared to healthy controls, indicating a strong inflammatory response post-infection.

Key potential diagnostic biomarkers include Interleukin 6, C-reactive protein, and tumor necrosis factor alpha, which may help in diagnosing and managing long COVID in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers in long COVID-19: A systematic review. Lai, YJ., Liu, SH., Manachevakul, S., et al.[2023]

COVID-19 survivors with post-COVID-19 syndrome (PCS) showed significantly higher levels of inflammatory and vascular biomarkers, such as C-reactive protein, D-dimer, lactate dehydrogenase, and leukocytes, compared to those without PCS, based on a meta-analysis of 23 studies.

The study suggests that these biomarker changes are more pronounced in PCS cases with organ abnormalities and those diagnosed within 6 months of infection, indicating potential pathways for understanding and treating PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory and vascular biomarkers in post-COVID-19 syndrome: A systematic review and meta-analysis of over 20 biomarkers. Yong, SJ., Halim, A., Halim, M., et al.[2023]

In a study examining post-acute sequelae of COVID-19 (PASC), it was found that 75% of patients with viral RNA in their blood (RNAemia) at the start were symptomatic later on.

RNAemia at presentation was a strong predictor of developing PASC, regardless of factors like patient demographics, initial disease severity, or duration of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between SARS-CoV-2 RNAemia and Post-Acute Sequelae of COVID-19. Ram-Mohan, N., Kim, D., Rogers, AJ., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Post-COVID-19 Patients Who Develop Lung Fibrotic-like Changes Have Lower Circulating Levels of IFN-β but Higher Levels of IL-1α and TGF-β. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Organ and cell-specific biomarkers of Long-COVID identified with targeted proteomics and machine learning. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Persistent Circulating Severe Acute Respiratory Syndrome Coronavirus 2 Spike Is Associated With Post-acute Coronavirus Disease 2019 Sequelae. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Biomarkers in long COVID-19: A systematic review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Inflammatory and vascular biomarkers in post-COVID-19 syndrome: A systematic review and meta-analysis of over 20 biomarkers. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Association Between SARS-CoV-2 RNAemia and Post-Acute Sequelae of COVID-19. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Association Between SARS-CoV-2 RNAemia and Postacute Sequelae of COVID-19. [2022]