<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/NCT04402840</url>
  </required_header>
  <id_info>
    <org_study_id>2004963113</org_study_id>
    <nct_id>NCT04402840</nct_id>
  </id_info>
  <brief_title>Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)</brief_title>
  <official_title>Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate&#xD;
      Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome&#xD;
      (ARDS) due to COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Aim:&#xD;
&#xD;
      • To determine safety of stellate ganglion block (SGB) in ARDS&#xD;
&#xD;
      Secondary Aim:&#xD;
&#xD;
        -  To determine efficacy of SGB in slowing the progression of ARDS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events related to SGB</measure>
    <time_frame>3 Months</time_frame>
    <description>Adverse events that can atleast unlikely be attributed to SGB</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All Adverse events</measure>
    <time_frame>3 Months</time_frame>
    <description>All adverse events related to COVID-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>3 Months</time_frame>
    <description>Death due to any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of respiratory/ pulmonary function</measure>
    <time_frame>3 Months</time_frame>
    <description>Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic criteria</measure>
    <time_frame>3 Months</time_frame>
    <description>Change from last imaging data obtained prior to SGB procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac function</measure>
    <time_frame>3 Months</time_frame>
    <description>Change from baseline clinical cardiac function as assessed by improvement in arrhythmia as measured by standard of care ECG ( rate, rhythm and / or any aberrant electro physiological changes)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Stellate Ganglion Block (SGB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinical Stellate ganglion block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stellate Ganglion Block</intervention_name>
    <description>The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.</description>
    <arm_group_label>Stellate Ganglion Block (SGB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects age 18 to 80&#xD;
&#xD;
          -  Subjects with PCR documented diagnosis of COVID-19 ARDS requiring critical care and&#xD;
             transfer to intensive care unit&#xD;
&#xD;
          -  Bilateral opacities consistent with pulmonary edema must be present and may be&#xD;
             detected on CT or chest radiograph&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with pre-existing cardiac failure&#xD;
&#xD;
          -  Hemodynamic Instability&#xD;
&#xD;
          -  Subject on Extracorporeal membrane oxygenation (ECMO)&#xD;
&#xD;
          -  Anatomical inability to do a stellate block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali R Rezai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Rockefeller Neuroscience Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Ali Rezai</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Acute Respiratory Distress Syndrome</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Autonomic Nervous System</keyword>
  <keyword>Stellate Ganglion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Ganglion Cysts</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04402840
org study id: 2004963113
nct id: NCT04402840
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate
      Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome
      (ARDS) due to COVID-19 infection.
Primary Aim:

      • To determine safety of stellate ganglion block (SGB) in ARDS

      Secondary Aim:

        -  To determine efficacy of SGB in slowing the progression of ARDS
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events related to SGB
time frame: 3 Months
description: Adverse events that can atleast unlikely be attributed to SGB
measure: All Adverse events
time frame: 3 Months
description: All adverse events related to COVID-19
measure: Death
time frame: 3 Months
description: Death due to any cause
measure: Assessment of respiratory/ pulmonary function
time frame: 3 Months
description: Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio
measure: Radiographic criteria
time frame: 3 Months
description: Change from last imaging data obtained prior to SGB procedure
measure: Cardiac function
time frame: 3 Months
description: Change from baseline clinical cardiac function as assessed by improvement in arrhythmia as measured by standard of care ECG ( rate, rhythm and / or any aberrant electro physiological changes)
arm group label: Stellate Ganglion Block (SGB)
arm group type: Experimental
description: Clinical Stellate ganglion block
intervention type: Procedure
intervention name: Stellate Ganglion Block
description: The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.
arm group label: Stellate Ganglion Block (SGB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ali R Rezai, MD
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: Ali Rezai
investigator title: Director
mesh term: COVID-19
mesh term: Ganglion Cysts
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome