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Search / Trial NCT06027255

Long COVID Immune Profiling

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Sep 6, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Sars Co V 2 Infection Pots Orthostatic Intolerance Long Covid Long Hauler Covid Infection

ClinConnect Summary

This clinical trial, called "Long COVID Immune Profiling," is investigating how the body's immune system behaves in individuals who have developed Postural Orthostatic Tachycardia Syndrome (POTS) after COVID-19. Researchers believe that POTS, which can cause symptoms like dizziness and increased heart rate when standing up, may be linked to a decrease in the function of a part of the nervous system called the parasympathetic nervous system (PNS). The PNS usually helps protect the body from inflammation, and this study aims to prove that lower PNS activity contributes to ongoing inflammation and POTS symptoms in people who have had COVID-19.

To participate in this trial, you must be at least 18 years old and have had a confirmed COVID-19 infection. You should also have experienced symptoms of POTS, like a rapid heartbeat and dizziness, for at least three months after your COVID-19 diagnosis. The study is currently recruiting participants of all genders. If you join, you can expect to undergo tests that will evaluate the activity of your immune cells and how this relates to your PNS function. It's important to note that certain medical conditions or treatments may prevent you from participating, so make sure to review the eligibility criteria carefully.

Gender

ALL

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

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported