Actively Recruiting
Long COVID Immune Profiling Study to Evaluate Parasympathetic Nervous System Activity and Inflammation in Post-COVID-19 POTS
Led by Vanderbilt University Medical Center · Updated on 2025-12-15
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand the link between reduced parasympathetic nervous system (PNS) activity and persistent inflammation in patients with post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS). It investigates how decreased PNS function, which normally helps protect against inflammation, may contribute to ongoing symptoms like orthostatic intolerance and inflammation after COVID-19 infection. The study includes patients with post-COVID-19 POTS, POTS without Long COVID, and controls with a history of COVID-19 but no lasting symptoms. Participants will be assessed for inflammatory markers such as IL-6 and cytokines (IL-17 and IFN-γ), and complete autonomic symptom questionnaires including COMPASS-31. The study is cross-sectional with up to 150 participants divided into three groups: post-COVID-19 POTS, POTS without Long COVID, and controls matched by gender, age, and BMI. Blood samples will be collected for laboratory analysis, and prior autonomic function tests will be reviewed when available. During the study visit, participants will complete questionnaires about autonomic symptoms, quality of life, and cognitive function. Blood tests will measure complete blood counts, inflammatory markers, and immune cell activity. The main outcome measured is the level of IL-6, with secondary outcomes including orthostatic symptom scores and other cytokines. Data will be analyzed to explore the relationship between PNS activity and immune response. The total participation includes a single study visit and use of past autonomic testing data.
CONDITIONS
Brief Title
Long COVID Immune Profiling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 18 years or older, men and women
- History of confirmed COVID-19 infection by symptoms, antigen test, or PCR
- Diagnosis of POTS defined by orthostatic tachycardia (>30 bpm) and chronic (>3 months) pre-syncopal symptoms
- For post-COVID-19 POTS, symptoms started within 2 months after COVID infection and persist until enrollment
You will not qualify if you...
- History of myocardial infarction, angina, heart failure, stroke, transient ischemic attack, or invasive cardiovascular procedures
- Inability to comply with study protocol or complete study visits
- Chronic use of steroids, anti-IL6 (omalizumab), anti-TNF-alpha, or other immunosuppressants
- Chronic use of NSAIDs within one week prior to blood sampling
- Treatment with plasmapheresis, IVIG, or other immune modulators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete questionnaires assessing autonomic symptoms and quality of life, undergo blood sample collection for inflammatory markers and cytokines, and have autonomic function tests reviewed from past records.
1 study visit (in-person)
Trial Site Locations
Total: 1 location
1
Cyndya Shibao
Nashville, Tennessee, United States, 37027
Actively Recruiting
Research Team
M
Marwa Mohamed, Phd
C
Cyndya Shibao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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