Long COVID Immune Profiling

Running, not enrolling · Not applicable

Conditions studied: Long COVID, POTS - Postural Orthostatic Tachycardia Syndrome, Autonomic Dysfunction

In brief

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 facts

Study ID

NCT06027255

Run by

Vanderbilt University Medical Center

People needed

150

Starts

2024-04-24

Expected to finish

2027-07-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Cyndya Shibao — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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