Status:
RECRUITING
Long COVID Immune Profiling
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
American Heart Association
Conditions:
Long COVID
POTS - Postural Orthostatic Tachycardia Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 persisten...
Detailed Description
COVID-19 infections can cause a disabling syndrome that persists beyond the 3-month convalescence period. The term post-acute COVID-19 syndrome or Long COVID is coined to describe a cluster of symptom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06027255
Start Date
April 24 2024
End Date
July 1 2027
Last Update
December 15 2025
Active Locations (1)
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1
Cyndya Shibao
Nashville, Tennessee, United States, 37027