| NCT ID | NCT06027255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Long COVID |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-04-24 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06027255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Long COVID. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06027255 currently recruiting?
Yes, NCT06027255 is actively recruiting participants. Contact the research team at marwa.mohamed@vumc.org for enrollment information.
Where is the NCT06027255 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06027255 clinical trial?
NCT06027255 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 150 participants.
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