Long COVID Immune Profiling
1 other identifier
observational
150
1 country
1
Brief Summary
Parasympathetic nervous system (PNS) is part of the body's autonomic nervous system(PNS) protects body against inflammation. Study shows that reduced PNS function activity is associated with persistent inflammation. Preliminary data from the studies shows, that post-COVID-19 POTS patients have reduced parasympathetic (PNS) function. Given that the PNS protects against inflammation, this clinical trial aims to prove that post-COVID-19 POTS is caused by reduced PNS activity, which in turn, contributes to persistent inflammation, orthostatic intolerance, and OI symptoms. The study will evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedSeptember 25, 2026
September 1, 2026
2.2 years
August 31, 2023
September 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IL-6 levels
Parasympathetic (PNS) function, protects against inflammation. To Evaluate level of inflammation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity. The primary endpoint is IL-6 levels
Baseline
Secondary Outcomes (2)
Orthostatic Symptoms Score
Baseline
cytokines (IL-17, and IFN-ɣ)
Baseline
Study Arms (3)
Post- COVID 19 POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31): In post-COVID-19 POTS (cases).
POTS patients
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: patients with diagnosis of POTS
Post- COVID 19 POTS patients with Controls
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: Controls are :COVID-19 infected without sequelae
Interventions
Compare IL-6 level , as a marker of inflammation in all the 3 groups: * POTS patients * post-COVID-19 POTS * gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae.
Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients
Compare Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in all the 3 groups: * POTS patients * post-COVID-19 POTS * gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae
Eligibility Criteria
The following subject population will be collected 1. The subjects with diagnosis of POTS 2. The subject who got POTS because of the COVID infection (Long COVID POTS) 3. Healthy controls: Subjects who do not have diagnosis of POTS or LONG COVID , after the COVID infection
You may qualify if:
- Subjects will be 18 years or older, men and women.
- History of confirmed COVID-19 infection (positive contact and symptoms, antigen test or PCR).
- POTS will be defined as the presence of orthostatic tachycardia (\>30 bpm) and chronic (\>3 months) pre-syncopal symptoms.
- Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (\>30 bpm) and chronic (\>3 months) pre-syncopal symptoms. Symptoms occurred within 2 months after COVID infection and persistent until enrollment in the study.
You may not qualify if:
- Individuals with a history of physician diagnosed myocardial infarction, angina, heart failure, stroke, or transient ischemic attack, or who had undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries).
- Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Chronic use of steroids, anti-IL6 (omalizumab), anti-TNF-alpha, other immunosuppressants.
- Chronic use of NSAID. Should not enroll if taking without one week prior to blood sampling.
- Treatment with plasmapheresis, IVIG or other immune modulator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- American Heart Associationcollaborator
Study Sites (1)
Cyndya Shibao
Nashville, Tennessee, 37027, United States
Biospecimen
Blood for Inflammatory markers/ Immunological essay Surveys and questionnaire to analyze the symptoms of the cases and controls and compare it to the inflammatory markers
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 7, 2023
Study Start
April 24, 2024
Primary Completion
June 30, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
September 25, 2026
Record last verified: 2026-09