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Behavioral Intervention

Immune Profiling for Post-COVID Syndrome

N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of confirmed COVID-19 infection (positive contact and symptoms, antigen test or PCR)
Be older than 18 years old
Must not have
History of physician diagnosed myocardial infarction, angina, heart failure, stroke, or transient ischemic attack, or invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries)
Treatment with plasmapheresis, IVIG or other immune modulator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

"This trial aims to investigate how reduced activity in a specific part of the nervous system, known as the parasympathetic nervous system (PNS), may lead to persistent inflammation and symptoms in post

Who is the study for?
This trial is for adults with a confirmed history of COVID-19 who now have symptoms like rapid heartbeat and dizziness when standing, known as POTS. These symptoms must have started within two months after COVID infection and lasted more than three months.
What is being tested?
The study tests if reduced function of the part of the nervous system that calms inflammation (PNS) leads to long-term symptoms in post-COVID patients. It involves measuring immune cell activation and comparing it with PNS activity levels.
What are the potential side effects?
Since this trial focuses on immune profiling rather than drug intervention, direct side effects from treatments are not applicable. However, there may be minor discomfort or risks associated with blood draws or other diagnostic procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a confirmed case of COVID-19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart issues or surgeries related to cardiovascular disease.
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I have received treatments like plasmapheresis or IVIG.
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I regularly use steroids or immunosuppressants like anti-IL6 or anti-TNF-alpha.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IL-6 levels
Secondary study objectives
Orthostatic Symptoms Score
cytokines (IL-17, and IFN-ɣ)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Post- COVID 19 POTS patients with ControlsExperimental Treatment3 Interventions
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: Controls are :COVID-19 infected without sequelae
Group II: Post- COVID 19 POTS patientsExperimental Treatment3 Interventions
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31): In post-COVID-19 POTS (cases).
Group III: POTS patientsExperimental Treatment3 Interventions
Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31):Gender, age, and BMI-matched: patients with diagnosis of POTS

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,784 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
780 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
American Heart AssociationOTHER
343 Previous Clinical Trials
4,971,448 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
108 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
~100 spots leftby Oct 2025
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