Long COVID Immune Profiling
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- IL-6
- cytokines (IL-17, and IFN-ɣ)
- Compass 31
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov