Long COVID Immune Profiling
NCT06027255 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-12-15
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.
Conditions
- Long COVID
- POTS - Postural Orthostatic Tachycardia Syndrome
- Autonomic Dysfunction
Interventions
- DIAGNOSTIC_TEST
-
IL-6
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.
- DIAGNOSTIC_TEST
-
cytokines (IL-17, and IFN-ɣ)
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
- BEHAVIORAL
-
Compass 31
Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients
Sponsors & Collaborators
- collaborator OTHER
-
Vanderbilt University Medical Center
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-24
- Primary Completion
- 2026-06-30
- Completion
- 2027-07-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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