150 Participants Needed

Immune Profiling for Post-COVID Syndrome

MM
CS
Overseen ByCyndya Shibao, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how issues with the parasympathetic nervous system (PNS), which normally protects the body from inflammation, might cause ongoing health problems after a COVID-19 infection. Researchers believe reduced PNS activity could link to ongoing inflammation and symptoms like dizziness when standing (a condition called POTS). Participants will help scientists understand the PNS's role by using a questionnaire called Compass 31 and tracking inflammation markers. The study seeks individuals who have experienced COVID-19, have ongoing dizziness, and symptoms that began within two months of infection. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on post-COVID-19 health issues.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as steroids, anti-IL6, anti-TNF-alpha, other immunosuppressants, and NSAIDs (non-steroidal anti-inflammatory drugs) at least one week before blood sampling. If you are on these medications, you may need to stop them to participate.

What prior data suggests that this protocol is safe?

Research has shown that the Compass 31 questionnaire reliably measures symptoms related to the autonomic nervous system, which controls automatic body functions like heart rate and digestion. Studies have found that the questionnaire effectively detects issues with these functions, especially in individuals who have had COVID-19.

For safety, it is important to note that Compass 31 is not a drug or treatment. As a questionnaire, it carries no physical side effects like those associated with medications. Instead, it aids doctors in determining if someone's autonomic nervous system is malfunctioning. This is particularly crucial for those with post-COVID POTS, a condition where standing up causes a rapid increase in heart rate.

In summary, using Compass 31 is safe. It is a questionnaire designed to help identify problems with the body's automatic functions, without the risks linked to drugs or invasive procedures.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the immune system changes in people with post-COVID syndrome, particularly those with POTS (Postural Orthostatic Tachycardia Syndrome). Unlike standard treatments that usually focus on symptom management, this study uses the Compass 31 questionnaire to assess autonomic symptoms and measures specific inflammatory markers like IL-6 and cytokines. By profiling these immune markers, the trial hopes to identify unique biological patterns that could lead to more targeted and effective treatments for post-COVID POTS, offering insights that current symptom-focused approaches may not provide.

What evidence suggests that the Compass 31 assessment is effective for evaluating post-COVID-19 POTS?

Research shows that many people with long COVID experience problems with automatic functions, such as heart rate and digestion. This trial will assess participants with post-COVID postural orthostatic tachycardia syndrome (POTS) using the COMPASS-31 questionnaire. Studies have found that high COMPASS-31 scores, averaging about 44, indicate moderate to severe issues with these functions. This finding supports the idea that lower activity in the parasympathetic nervous system (PNS) links to ongoing inflammation and symptoms like difficulty standing. Addressing these issues could improve symptoms for those with post-COVID POTS.13467

Are You a Good Fit for This Trial?

This trial is for adults with a confirmed history of COVID-19 who now have symptoms like rapid heartbeat and dizziness when standing, known as POTS. These symptoms must have started within two months after COVID infection and lasted more than three months.

Inclusion Criteria

I have had a confirmed case of COVID-19.
I have had fast heart rate and dizziness for over 3 months after getting COVID-19.
I have been diagnosed with POTS and experience rapid heartbeat and near-fainting for over 3 months.

Exclusion Criteria

I have received treatments like plasmapheresis or IVIG.
I regularly use steroids or immunosuppressants like anti-IL6 or anti-TNF-alpha.
I have a history of heart issues or surgeries related to cardiovascular disease.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study Visit

Participants undergo assessments including autonomic symptoms assessment, quality of life evaluation, and blood sample collection

1 day
1 visit (in-person)

Data Analysis

Data analysis including demographic information tabulation and statistical tests on collected data

4-8 weeks

Follow-up

Participants are monitored for any changes in autonomic symptoms and inflammatory markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Compass 31
Trial Overview The study tests if reduced function of the part of the nervous system that calms inflammation (PNS) leads to long-term symptoms in post-COVID patients. It involves measuring immune cell activation and comparing it with PNS activity levels.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Post- COVID 19 POTS patients with ControlsExperimental Treatment3 Interventions
Group II: Post- COVID 19 POTS patientsExperimental Treatment3 Interventions
Group III: POTS patientsExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Published Research Related to This Trial

A study of 112 patients recovering from COVID-19 showed that while autonomic symptoms and quality of life initially improved after discharge, many patients experienced a worsening of symptoms at 6 and 12 months, indicating a significant risk for Long-COVID autonomic syndrome.
The findings suggest that early rehabilitative and pharmacological interventions are crucial for patients shortly after infection to help prevent the development of long-term autonomic issues.
The Long-COVID autonomic syndrome in hospitalized patients: A one-year prospective cohort study.Rigo, S., Barbic, F., Khalaf, K., et al.[2023]
In a study of 184 post-COVID-19 patients, most reported over 10 symptoms, with fatigue (84.9%) and decreased physical capacity (83.0%) being the most common, highlighting the significant symptom burden associated with post-COVID-19 syndrome (PCS).
Clinical assessments revealed abnormalities in fatigue, cognition, and lung function, indicating that ongoing monitoring and interdisciplinary care are crucial for managing PCS symptoms, which often persist and evolve over time.
Longitudinal Clinical Features of Post-COVID-19 Patients-Symptoms, Fatigue and Physical Function at 3- and 6-Month Follow-Up.Steinmetz, A., Gross, S., Lehnert, K., et al.[2023]
In a study of 39 participants, those with long COVID-19 and fatigue showed significant autonomic dysregulation, as indicated by changes in the NOL index, compared to control participants without COVID-19.
The findings suggest that dysautonomia may be a key factor in the persistent symptoms experienced by long COVID-19 patients, such as fatigue and hypoxia, highlighting the need for further investigation into autonomic nervous system involvement in long COVID.
Clinical characterization of dysautonomia in long COVID-19 patients.Barizien, N., Le Guen, M., Russel, S., et al.[2022]

Citations

Postural orthostatic tachycardia syndrome in post-COVID- ...Our naïve and COVID-19 recovered healthy control groups had similar low COMPASS-31 scores (< 20, the normal cut-off score) in contrast with naïve POTS (score = ...
Evaluating Long-Term Autonomic Dysfunction and ...Key results 71.9% of Long COVID patients had a COMPASS-31 score >20, suggestive of moderate to severe autonomic dysfunction.
Characterization of autonomic symptom burden in long ...Key results: Sixty-six percent of PASC patients had a COMPASS-31 score >20, suggestive of moderate to severe autonomic dysfunction. COMPASS-31 scores did not ...
Post-COVID postural orthostatic tachycardia syndrome ...The post-COVID POTS patients who took the COMPASS-31 autonomic questionnaire showed an average score of 44 (n = 7).
Composite Autonomic Symptom Score-31 for the diagnosis ...COMPASS-31 could be used as a user-friendly screening tool to detect autonomic dysfunction in post-COVID-19 cases with acceptable sensitivity ...
Post-COVID postural orthostatic tachycardia syndrome ...The COMPASS-31 questionnaire measures patient-reported outcomes related to autonomic symptoms. This questionnaire has 31 questions and is ...
The Long-COVID autonomic syndrome in hospitalized ...47% of Long-COVID autonomic syndrome patients exhibit autonomic-related symptoms and reduced quality of life at 6 months and one-year follow-ups.
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