RNA Biomarker Blood Test for Post-COVID Syndrome

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MaxWell Clinic, PLC

Disqualifiers: Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the RNA Biomarker Blood Test can identify RNA markers to distinguish long COVID from other conditions with similar symptoms. The study includes different groups: individuals with long COVID symptoms like shortness of breath or brain fog, those who had COVID without long-term effects, and people who never had COVID. It seeks participants who have had COVID-19 with ongoing symptoms or those who had COVID but recovered. Those experiencing persistent issues like breathlessness or confusion after a COVID infection may find this trial suitable. Participants will provide blood samples and complete surveys to aid researchers in developing a diagnostic tool. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to better diagnostic tools for 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 prior data suggests that the RNA Biomarker Blood Test is safe?

Research has shown that blood tests using RNA (a molecule that helps make proteins) can help identify long COVID symptoms. Researchers are studying this test to determine if it can detect blood differences related to symptoms after a COVID infection.

The RNA Biomarker Blood Test itself poses no specific safety concerns, as it only involves taking a blood sample. This procedure is similar to other medical blood tests and is generally considered safe. Studies reviewed have reported no negative effects.

This is part of ongoing research to better understand how the blood test can be used for people with long COVID. Those interested in participating in a trial can feel reassured about the safety of this blood draw procedure based on current data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RNA Biomarker Blood Test for post-COVID syndrome because it offers a new way to understand and diagnose long COVID. Unlike traditional methods that rely on symptom observation and patient history, this test uses RNA biomarkers to detect molecular changes in the blood, providing a more precise and objective measure of post-COVID conditions. This approach could lead to quicker identification and treatment of long COVID, potentially improving patient outcomes by targeting the underlying biological changes rather than just managing symptoms.

What evidence suggests that the RNA Biomarker Blood Test is effective for identifying long COVID?

Research shows that certain blood markers, called RNA markers, might help identify long COVID, which refers to the ongoing effects some people experience after a COVID-19 infection. This trial will evaluate the RNA Biomarker Blood Test across various participant groups. Participants include those with long COVID symptoms, such as respiratory or neurological issues, and those without long COVID, serving as control groups. Studies have found that these markers can distinguish between people with and without long COVID by examining how their immune systems reacted to the virus. In another study, different blood markers were linked to specific symptoms like breathing problems or nervous system issues. These findings suggest that blood tests might help understand and diagnose long COVID by identifying unique patterns. Early findings indicate that these tests could be a useful tool in identifying and understanding long COVID symptoms. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

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

I have new, ongoing symptoms from a past COVID-19 infection.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• RNA Biomarker Blood Test

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

MaxWell Clinic, PLC

Lead Sponsor

Trials

2

Recruited

270+

Published Research Related to This Trial

In a study examining patients with COVID-19, 83.3% of those who had viral RNA in their blood (RNAemia) at the start showed symptoms in the post-acute phase, indicating a strong link between RNAemia and post-acute sequelae of COVID-19 (PASC).

RNAemia at presentation was found to be a reliable predictor of PASC, regardless of other factors like patient demographics, severity of the initial disease, or duration of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10341908/

Laboratory Findings and Biomarkers in Long COVID Laboratory findings and biomarkers in long COVID: what do we know so far? Insights into epidemiology, pathogenesis, therapeutic perspectives and challenges.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666354625001681

Blood diagnostic biomarkers for neurologic manifestations ... “Long Covid”, a Post-Acute Sequelae of COVID-19 (PASC), is an ongoing global healthcare problem, affecting all age groups, with many manifestations, and ...

3. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00236-1/fulltext

Symptoms and pathophysiology of post-acute sequelae ... The study analysed association between persistent symptoms and 14 blood biomarkers, comparing participants with PASC with recovered participants ...

4. nature.com nature.com/articles/s41467-024-51893-7

Early biological markers of post-acute sequelae of SARS- ... Our results suggest early viral dynamics and the associated host immune responses play a role in the pathogenesis of PASC.

5. academic.oup.com academic.oup.com/ofid/article/11/9/ofae462/7733485

Postacute Sequelae of COVID (PASC or Long COVID) Here, we share the evidence regarding the abnormalities associated with postacute sequelae of COVID-19 (PASC) and therapeutics.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11363684/

Postacute Sequelae of COVID (PASC or Long COVID) Acute blood biomarker profiles can predict cognitive deficits months after COVID-19 hospitalization, suggesting that inflammatory abnormalities may start ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06974084

NCT06974084 | Investigating Measurable PRO Acuity Trial ... The main goals of the clinical study are to determine if this combination drug therapy can improve neurocognitive and physical functions in Long Covid patients, ...