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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met