Long COVID Immune Profiling

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06027255
Status
Recruiting
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Conditions

  • Autonomic Dysfunction
  • Long COVID
  • POTS - Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • IL-6 — DIAGNOSTIC_TEST
    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.
  • cytokines (IL-17, and IFN-ɣ) — DIAGNOSTIC_TEST
    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
  • Compass 31 — BEHAVIORAL
    Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients

Study Details

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.

Key Dates

Start date
Apr 24, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: 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).
  • Other: 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
  • Other: 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

Primary Outcome Measure

IL-6 levels [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cyndya ShibaoNashvilleTennessee37027
Cyndya Shibao, RN
[email protected]
Cyndya A Shibao, MD (PRINCIPAL_INVESTIGATOR)

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Cyndya Shibao· Nashville, TN

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