Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)

• ClinicalTrials.gov Identifier: NCT04402840
• Recruitment Status: Recruiting
• First Posted: May 27, 2020
• Last Update Posted: November 3, 2020
• Sponsor: West Virginia University
• Information provided by (Responsible Party): Ali Rezai, West Virginia University

Tracking Information

• First Submitted Date: May 22, 2020
• First Posted Date: May 27, 2020
• Last Update Posted Date: November 3, 2020
• Actual Study Start Date: April 24, 2020
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 22, 2020)

• Adverse events related to SGB [ Time Frame: 3 Months ]
  Adverse events that can atleast unlikely be attributed to SGB
• All Adverse events [ Time Frame: 3 Months ]
  All adverse events related to COVID-19
• Death [ Time Frame: 3 Months ]
  Death due to any cause

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 29, 2020)

• Assessment of respiratory/ pulmonary function [ Time Frame: 3 Months ]
  Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio
• Radiographic criteria [ Time Frame: 3 Months ]
  Change from last imaging data obtained prior to SGB procedure
• Cardiac function [ Time Frame: 3 Months ]
  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)

Original Secondary Outcome Measures (submitted: May 22, 2020)

• PaO2/FiO2 or SpO2/FiO2(SF) ratio change from baseline [ Time Frame: 3 Months ]
  Change from baseline (descibed as last ratio prior to procedure)
• Radiographic criteria [ Time Frame: 3 Months ]
  Change from last imaging data obtained prior to SGB procedure
• Incidence of cardiac arrhythmia [ Time Frame: 3 Months ]
• Resolution of cardiac arrhythmia [ Time Frame: 3 Months ]
• Cardiac function [ Time Frame: 3 Months ]
• Clinical relevant Laboratory testing (d-dimer, Ferritin, Troponin T, LDH) [ Time Frame: 3 Months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
• Official Title: Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
• Brief Summary: 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.

Detailed Description

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Acute Respiratory Distress Syndrome
• COVID-19

Intervention

Procedure: Stellate Ganglion Block

The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.

Study Arms

Experimental: Stellate Ganglion Block (SGB)

Clinical Stellate ganglion block

Intervention: Procedure: Stellate Ganglion Block

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 22, 2020): 5
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects age 18 to 80
• Subjects with PCR documented diagnosis of COVID-19 ARDS requiring critical care and transfer to intensive care unit
• Bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph

Exclusion Criteria:

• Subjects with pre-existing cardiac failure
• Hemodynamic Instability
• Subject on Extracorporeal membrane oxygenation (ECMO)
• Anatomical inability to do a stellate block

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Padma Tirumalai, PhD; 3042934999; ptirumalai@hsc.wvu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04402840
• Other Study ID Numbers: 2004963113
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Ali Rezai, West Virginia University
• Study Sponsor: West Virginia University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ali R Rezai, MD; West Virginia University

• PRS Account: West Virginia University
• Verification Date: July 2020