NCT04402840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

May 22, 2020

Last Update Submit

April 22, 2025

Conditions

Keywords

Acute Respiratory Distress SyndromeCOVID-19Autonomic Nervous SystemStellate Ganglion

Outcome Measures

Primary Outcomes (3)

  • Adverse events related to SGB

    Adverse events that can atleast unlikely be attributed to SGB

    3 Months

  • All Adverse events

    All adverse events related to COVID-19

    3 Months

  • Death

    Death due to any cause

    3 Months

Secondary Outcomes (3)

  • Assessment of respiratory/ pulmonary function

    3 Months

  • Radiographic criteria

    3 Months

  • Cardiac function

    3 Months

Study Arms (1)

Stellate Ganglion Block (SGB)

EXPERIMENTAL

Clinical Stellate ganglion block

Procedure: Stellate Ganglion Block

Interventions

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

Stellate Ganglion Block (SGB)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Ali R Rezai, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 27, 2020

Study Start

April 24, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations