Investigating immune responses in Long COVID and POTS patients
Long COVID Immune Profiling
This study is testing how immune responses and nervous system function relate to symptoms in people with Long COVID and POTS to find better ways to manage their conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | omalizumab |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06027255 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the relationship between reduced parasympathetic nervous system (PNS) function and persistent inflammation in patients suffering from Long COVID and Postural Orthostatic Tachycardia Syndrome (POTS). It will evaluate immune cell activation in individuals with a history of COVID-19 infection, comparing those with POTS symptoms to those without. The study seeks to establish a correlation between decreased PNS activity and the severity of symptoms such as orthostatic intolerance and chronic tachycardia. By understanding these mechanisms, the trial hopes to identify potential therapeutic targets for managing these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed history of COVID-19 infection and symptoms of POTS persisting for more than three months.
Not a fit: Patients with a history of significant cardiovascular disease or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for patients suffering from Long COVID and POTS, potentially alleviating debilitating symptoms.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a link between viral infections and POTS, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Cyndya Shibao — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Marwa Mohamed, Phd
- Email: marwa.mohamed@vumc.org
- Phone: 6159702384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.