Health TrialsbyHealthPanel

Long COVID Immune Profiling

ConditionsLong COVIDPOTS - Postural Orthostatic Tachycardia SyndromeAutonomic Dysfunction
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • IL-6

    Diagnostic test

    Compare IL-6 level , as a marker of inflammation in all the 3 groups: * POTS patients * post-COVID-19 POTS * gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae.

  • cytokines (IL-17, and IFN-ɣ)

    Diagnostic test

    Compare Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in all the 3 groups: * POTS patients * post-COVID-19 POTS * gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae

  • Compass 31

    Behavioral

    Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Post- COVID 19 POTS patientsOther 3 interventions
Group B: POTS patientsOther 3 interventions
Group C: Post- COVID 19 POTS patients with ControlsOther 3 interventions

Trial outcomes

Primary outcomes

1

IL-6 levels

Parasympathetic (PNS) function, protects against inflammation. To Evaluate level of inflammation 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. The primary endpoint is IL-6 levels

Time frame
Baseline

Secondary outcomes

1

Orthostatic Symptoms Score

Standardized Orthostatic Symptoms Score COMPASS-31: Composite Autonomic Symptom Score The COMPASS-31 is a widely-utilized patient questionnaire that provides a quantitative assessment of the severity and distribution of autonomic symptoms . This questionnaire generates a weighted score from 0 to 100, and questions fall into one of six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor function.

Time frame
Baseline
2

cytokines (IL-17, and IFN-ɣ)

Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in Post-COVID-19 POTS patients, comparing to controls

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

American Heart Association

Collaborator

Source ClinicalTrials.gov
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