Immune Profiling for Post-COVID Syndrome
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Study Visit
Participants undergo assessments including autonomic symptoms assessment, quality of life evaluation, and blood sample collection
Data Analysis
Data analysis including demographic information tabulation and statistical tests on collected data
Follow-up
Participants are monitored for any changes in autonomic symptoms and inflammatory markers
What Are the Treatments Tested in This Trial?
Interventions
- Compass 31
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
American Heart Association
Collaborator