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Active Not Recruiting
NCT06027255
Long COVID Immune Profiling
Conditions: Long COVID, POTS - Postural Orthostatic Tachycardia Syndrome, Autonomic Dysfunction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 150
Sponsor: Vanderbilt University Medical Center
Location: Cyndya Shibao Nashville Tennessee
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06027255). StuddyBuddy aggregates publicly available trial information.