xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027255</url>
    </required_header>
    <id_info>
      <org_study_id>Long COVID</org_study_id>
      <nct_id>NCT06027255</nct_id>
    </id_info>
    <brief_title>Long COVID Immune Profiling</brief_title>
    <official_title>Long COVID Immune Profiling</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Heart Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vanderbilt University Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Parasympathetic nervous system (PNS) is part of the body's autonomic nervous system(PNS)&#xD;
        protects body against inflammation. Study shows that reduced PNS function activity is&#xD;
        associated with persistent inflammation.&#xD;
  &#xD;
        Preliminary data from the studies shows, that post-COVID-19 POTS patients have reduced&#xD;
        parasympathetic (PNS) function. Given that the PNS protects against inflammation, this&#xD;
        clinical trial aims to prove that post-COVID-19 POTS is caused by reduced PNS activity, which&#xD;
        in turn, contributes to persistent inflammation, orthostatic intolerance, and OI symptoms.&#xD;
  &#xD;
        The study will evaluate immune cell activation in post-COVID-19 POTS and patients with&#xD;
        history of COVID-19 infection without sequelae and correlate this with the degree of&#xD;
        decreased PNS activity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        COVID-19 infections can cause a disabling syndrome that persists beyond the 3-month&#xD;
        convalescence period. The term post-acute COVID-19 syndrome or Long COVID is coined to&#xD;
        describe a cluster of symptoms consisting of fatigue, chest pain, reduced exercise tolerance,&#xD;
        tachycardia, and cognitive impairment.&#xD;
  &#xD;
        Persistent tachycardia remains one of the most common complaints, reported in 9% of patients&#xD;
        at 6 months post-infection. These symptoms overlap with those present in patients with&#xD;
        Postural orthostatic tachycardia syndrome (POTS). It is noteworthy that about half of POTS&#xD;
        patients also report a history of viral infection prior to the development of these symptoms.&#xD;
  &#xD;
        Post-COVID-19 tachycardia syndrome, POTS variant: It present with chronic tachycardia with&#xD;
        symptoms of orthostatic intolerance (OI) without any other identifiable cause. In addition,&#xD;
        non-specific symptoms such as fatigue, headache, and &quot;brain fog&quot;, commonly described in POTS&#xD;
        patients are also present in this novel condition.&#xD;
  &#xD;
        Elevated levels of inflammatory markers CRP,D-dimer and IL-6 are found in Long COVID&#xD;
        patients. Data in POTS, which resembles post-COVID tachycardia syndrome, shows increased&#xD;
        cytokines including IL-6, IL-1b, and TNF-a.&#xD;
  &#xD;
        Notably, stimulation of the efferent vagus nerve (PNS), has been shown to reduce&#xD;
        proinflammatory markers production and systemic inflammation. Hence, decreased PNS function,&#xD;
        as reported with acute SARS-CoV-2 infection and in post-COVID-19 POTS patients, may render&#xD;
        these patients prone to persistent inflammation. To determine the link between PNS activity&#xD;
        and immune activation in post-COVID-19 POTS, the study aims to evaluate immune cell&#xD;
        activation in post-COVID-19 POTS and patients with history of COVID-19 infection without&#xD;
        sequelae and correlate this with the degree of decreased PNS activity.&#xD;
  &#xD;
        Rationale and Specific Aims:&#xD;
  &#xD;
        Preliminary data shows that post-COVID-19 POTS patients have reduced parasympathetic (PNS)&#xD;
        function. Given that the PNS protects against inflammation, we hypothesize that post-COVID-19&#xD;
        POTS is caused by reduced PNS activity, which in turn, contributes to persistent&#xD;
        inflammation, orthostatic intolerance, and OI symptoms.&#xD;
  &#xD;
        Primary Aim: Test the hypothesis that reduced PNS activity is associated with persistent&#xD;
        inflammation in patients with post-COVID-19 POTS.&#xD;
  &#xD;
        Study Participants:&#xD;
  &#xD;
        This is a cross-sectional study conducted, up to 150 patients will be enrolled, 50 POTS&#xD;
        without Long-COVID, 50 POTS with Long-COVID and 50 controls with history of COVID-19&#xD;
        infection without sequelae.&#xD;
  &#xD;
        Study Procedures&#xD;
  &#xD;
        Recruitment: Subjects will be recruited from referrals to the Vanderbilt Autonomic&#xD;
        Dysfunction Center (ADC)&#xD;
  &#xD;
        Study visit:&#xD;
  &#xD;
        Assessments:&#xD;
  &#xD;
          -  Autonomic symptoms assessment questionnaire (COMPASS-31)&#xD;
  &#xD;
          -  Quality of life EQ-5D&#xD;
  &#xD;
          -  PROMIS scale (Functional Activities Questionnaire in Older Adults with Dementia),&#xD;
  &#xD;
          -  OHQ (Orthostatic Hypotension Questionnaire)&#xD;
  &#xD;
          -  CBS (Cambridge Brain sciences: Web based cognitive assessment platform, Optional), and&#xD;
             neuropsychological tests Blood sample collection: CBC, CMP, C-reactive protein (CRP),&#xD;
             D-dimer, Flow cytometry study, PBMC isolation Autonomic function tests: Testing&#xD;
             performed at Vanderbilt ADC within 10 years of the study visit will be utilized. Testing&#xD;
             will not be repeated solely for the purposes of this study.&#xD;
  &#xD;
        Statistical Considerations&#xD;
  &#xD;
        Biostatistical Section The primary endpoint serum IL-6. The proposed sample size of 150 (50&#xD;
        POTD, 50 Long COVID POTS patients and 50 controls) provides more than 90% power to detect an&#xD;
        effect size of 0.62 for the mean difference in IL-6 between post-COVID-19 POTS (cases) and&#xD;
        controls (COVID-19 infected w/o sequelae), with the two-sided type I error = 5%. This&#xD;
        calculation is based on the preliminary data of mean difference of IL-6 ≈ 1.82 and the SD ≈&#xD;
        2.94 in POTS.16 The effect size is defined as the ratio of mean IL-6 difference between cases&#xD;
        and controls to standard deviation.&#xD;
  &#xD;
        Data analysis plan: Demographic information will be tabulated. Descriptive statistics,&#xD;
        including means, standard deviations, and ranges for continuous parameters, as well as&#xD;
        percent and frequencies for categorical parameters, will be presented. T-test or Mann-Whitney&#xD;
        (as appropriate) will be applied to examine the mean differences between cases and control&#xD;
        with respect to the outcomes. The conditional logistic regression model will be applied for&#xD;
        the multivariable data analysis. The adjusted p-values and the adjusted 95% confidence&#xD;
        intervals (CIs) will be reported.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>To enroll up to 150 patients, 50 POTS without Long-COVID, 50 POTS with Long-COVID and 50 controls with history of COVID-19 infection without sequelae</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>IL-6 levels</measure>
      <time_frame>Baseline</time_frame>
      <description>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.&#xD;
  The primary endpoint is IL-6 levels</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Orthostatic Symptoms Score</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cytokines (IL-17, and IFN-ɣ)</measure>
      <time_frame>Baseline</time_frame>
      <description>Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in Post-COVID-19 POTS patients, comparing to controls</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Long COVID</condition>
    <condition>POTS - Postural Orthostatic Tachycardia Syndrome</condition>
    <condition>Autonomic Dysfunction</condition>
    <arm_group>
      <arm_group_label>Post- COVID 19 POTS patients</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31): In post-COVID-19 POTS (cases).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>POTS patients</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Post- COVID 19 POTS patients with Controls</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>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</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>IL-6</intervention_name>
      <description>Compare IL-6 level , as a marker of inflammation in all the 3 groups:&#xD;
  POTS patients&#xD;
  post-COVID-19 POTS&#xD;
  gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae.</description>
      <arm_group_label>POTS patients</arm_group_label>
      <arm_group_label>Post- COVID 19 POTS patients</arm_group_label>
      <arm_group_label>Post- COVID 19 POTS patients with Controls</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>cytokines (IL-17, and IFN-ɣ)</intervention_name>
      <description>Compare Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in all the 3 groups:&#xD;
  POTS patients&#xD;
  post-COVID-19 POTS&#xD;
  gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae</description>
      <arm_group_label>POTS patients</arm_group_label>
      <arm_group_label>Post- COVID 19 POTS patients</arm_group_label>
      <arm_group_label>Post- COVID 19 POTS patients with Controls</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Compass 31</intervention_name>
      <description>Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients</description>
      <arm_group_label>POTS patients</arm_group_label>
      <arm_group_label>Post- COVID 19 POTS patients</arm_group_label>
      <arm_group_label>Post- COVID 19 POTS patients with Controls</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects will be 18 years or older, men and women.&#xD;
  &#xD;
            -  History of confirmed COVID-19 infection (positive contact and symptoms, antigen test&#xD;
               or PCR).&#xD;
  &#xD;
            -  POTS will be defined as the presence of orthostatic tachycardia (&gt;30 bpm) and chronic&#xD;
               (&gt;3 months) pre-syncopal symptoms.&#xD;
  &#xD;
            -  Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (&gt;30&#xD;
               bpm) and chronic (&gt;3 months) pre-syncopal symptoms. Symptoms occurred within 2 months&#xD;
               after COVID infection and persistent until enrollment in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with a history of physician diagnosed myocardial infarction, angina, heart&#xD;
               failure, stroke, or transient ischemic attack, or who had undergone an invasive&#xD;
               procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement,&#xD;
               pacemaker placement or other vascular surgeries).&#xD;
  &#xD;
            -  Inability to comply with the protocol, e.g. uncooperative attitude, inability to&#xD;
               return for follow-up visits, and unlikelihood of completing the study.&#xD;
  &#xD;
            -  Chronic use of steroids, anti-IL6 (omalizumab), anti-TNF-alpha, other&#xD;
               immunosuppressants.&#xD;
  &#xD;
            -  Chronic use of NSAID. Should not enroll if taking without one week prior to blood&#xD;
               sampling.&#xD;
  &#xD;
            -  Treatment with plasmapheresis, IVIG or other immune modulator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
      <investigator_full_name>Cyndya Shibao, MD</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>SARS-CoV-2 infection</keyword>
    <keyword>POTS</keyword>
    <keyword>Orthostatic Intolerance</keyword>
    <keyword>Long COVID</keyword>
    <keyword>Long hauler COVID infection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
      <mesh_term>Autonomic Nervous System Diseases</mesh_term>
      <mesh_term>Primary Dysautonomias</mesh_term>
      <mesh_term>Postural Orthostatic Tachycardia Syndrome</mesh_term>
      <mesh_term>Tachycardia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027255
  org study id: Long COVID
  nct id: NCT06027255
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  COVID-19 infections can cause a disabling syndrome that persists beyond the 3-month
        convalescence period. The term post-acute COVID-19 syndrome or Long COVID is coined to
        describe a cluster of symptoms consisting of fatigue, chest pain, reduced exercise tolerance,
        tachycardia, and cognitive impairment.
  
        Persistent tachycardia remains one of the most common complaints, reported in 9% of patients
        at 6 months post-infection. These symptoms overlap with those present in patients with
        Postural orthostatic tachycardia syndrome (POTS). It is noteworthy that about half of POTS
        patients also report a history of viral infection prior to the development of these symptoms.
  
        Post-COVID-19 tachycardia syndrome, POTS variant: It present with chronic tachycardia with
        symptoms of orthostatic intolerance (OI) without any other identifiable cause. In addition,
        non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS
        patients are also present in this novel condition.
  
        Elevated levels of inflammatory markers CRP,D-dimer and IL-6 are found in Long COVID
        patients. Data in POTS, which resembles post-COVID tachycardia syndrome, shows increased
        cytokines including IL-6, IL-1b, and TNF-a.
  
        Notably, stimulation of the efferent vagus nerve (PNS), has been shown to reduce
        proinflammatory markers production and systemic inflammation. Hence, decreased PNS function,
        as reported with acute SARS-CoV-2 infection and in post-COVID-19 POTS patients, may render
        these patients prone to persistent inflammation. To determine the link between PNS activity
        and immune activation in post-COVID-19 POTS, the study aims to 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.
  
        Rationale and Specific Aims:
  
        Preliminary data shows that post-COVID-19 POTS patients have reduced parasympathetic (PNS)
        function. Given that the PNS protects against inflammation, we hypothesize that post-COVID-19
        POTS is caused by reduced PNS activity, which in turn, contributes to persistent
        inflammation, orthostatic intolerance, and OI symptoms.
  
        Primary Aim: Test the hypothesis that reduced PNS activity is associated with persistent
        inflammation in patients with post-COVID-19 POTS.
  
        Study Participants:
  
        This is a cross-sectional study conducted, up to 150 patients will be enrolled, 50 POTS
        without Long-COVID, 50 POTS with Long-COVID and 50 controls with history of COVID-19
        infection without sequelae.
  
        Study Procedures
  
        Recruitment: Subjects will be recruited from referrals to the Vanderbilt Autonomic
        Dysfunction Center (ADC)
  
        Study visit:
  
        Assessments:
  
          -  Autonomic symptoms assessment questionnaire (COMPASS-31)
  
          -  Quality of life EQ-5D
  
          -  PROMIS scale (Functional Activities Questionnaire in Older Adults with Dementia),
  
          -  OHQ (Orthostatic Hypotension Questionnaire)
  
          -  CBS (Cambridge Brain sciences: Web based cognitive assessment platform, Optional), and
             neuropsychological tests Blood sample collection: CBC, CMP, C-reactive protein (CRP),
             D-dimer, Flow cytometry study, PBMC isolation Autonomic function tests: Testing
             performed at Vanderbilt ADC within 10 years of the study visit will be utilized. Testing
             will not be repeated solely for the purposes of this study.
  
        Statistical Considerations
  
        Biostatistical Section The primary endpoint serum IL-6. The proposed sample size of 150 (50
        POTD, 50 Long COVID POTS patients and 50 controls) provides more than 90% power to detect an
        effect size of 0.62 for the mean difference in IL-6 between post-COVID-19 POTS (cases) and
        controls (COVID-19 infected w/o sequelae), with the two-sided type I error = 5%. This
        calculation is based on the preliminary data of mean difference of IL-6 ≈ 1.82 and the SD ≈
        2.94 in POTS.16 The effect size is defined as the ratio of mean IL-6 difference between cases
        and controls to standard deviation.
  
        Data analysis plan: Demographic information will be tabulated. Descriptive statistics,
        including means, standard deviations, and ranges for continuous parameters, as well as
        percent and frequencies for categorical parameters, will be presented. T-test or Mann-Whitney
        (as appropriate) will be applied to examine the mean differences between cases and control
        with respect to the outcomes. The conditional logistic regression model will be applied for
        the multivariable data analysis. The adjusted p-values and the adjusted 95% confidence
        intervals (CIs) will be reported.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: To enroll up to 150 patients, 50 POTS without Long-COVID, 50 POTS with Long-COVID and 50 controls with history of COVID-19 infection without sequelae
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: IL-6 levels
  time frame: Baseline
  description: 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
  measure: Orthostatic Symptoms Score
  time frame: Baseline
  description: 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.
  measure: cytokines (IL-17, and IFN-ɣ)
  time frame: Baseline
  description: Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in Post-COVID-19 POTS patients, comparing to controls
  arm group label: Post- COVID 19 POTS patients
  arm group type: Other
  description: Inflammatory markers IL-6,Cytokines (IL-17, and IFN-ɣ), Autonomic symptoms assessment questionnaire (COMPASS 31): In post-COVID-19 POTS (cases).
  arm group label: POTS patients
  arm group type: Other
  description: 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
  arm group label: Post- COVID 19 POTS patients with Controls
  arm group type: Other
  description: 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
  intervention type: Diagnostic Test
  intervention name: IL-6
  description: 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.
  arm group label: POTS patients
  arm group label: Post- COVID 19 POTS patients
  arm group label: Post- COVID 19 POTS patients with Controls
  intervention type: Diagnostic Test
  intervention name: cytokines (IL-17, and IFN-ɣ)
  description: 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
  arm group label: POTS patients
  arm group label: Post- COVID 19 POTS patients
  arm group label: Post- COVID 19 POTS patients with Controls
  intervention type: Behavioral
  intervention name: Compass 31
  description: Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients
  arm group label: POTS patients
  arm group label: Post- COVID 19 POTS patients
  arm group label: Post- COVID 19 POTS patients with Controls
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt University Medical Center
  investigator full name: Cyndya Shibao, MD
  investigator title: Associate Professor
  mesh term: Post-Acute COVID-19 Syndrome
  mesh term: Autonomic Nervous System Diseases
  mesh term: Primary Dysautonomias
  mesh term: Postural Orthostatic Tachycardia Syndrome
  mesh term: Tachycardia