Acute Respiratory Distress SyndromeNCT04402840
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
A study testing Stellate Ganglion Block in people with Acute Respiratory Distress Syndrome and COVID-19, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID-19
- What is being tested?
- Stellate Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with pre-existing cardiac failure
- Hemodynamic Instability
- Subject on Extracorporeal membrane oxygenation (ECMO)
- Anatomical inability to do a stellate block
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26506
About this study
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.
Read the 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
- Conditions
- Acute Respiratory Distress Syndrome, COVID-19
- Being tested
- Stellate Ganglion Block
- Keywords
- Acute Respiratory Distress Syndrome, COVID-19, Autonomic Nervous System, Stellate Ganglion
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block (SGB) | Experimental | Clinical Stellate ganglion block Receives: Procedure: Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to SGB
Adverse events that can atleast unlikely be attributed to SGB
Measured: 3 Months
All Adverse events
All adverse events related to COVID-19
Measured: 3 Months
Death
Death due to any cause
Measured: 3 Months
Secondary outcomes (3)
Assessment of respiratory/ pulmonary function
Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio
Measured: 3 Months
Radiographic criteria
Change from last imaging data obtained prior to SGB procedure
Measured: 3 Months
Cardiac function
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)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start24 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Rezai, West Virginia University
- Investigators
- Ali R Rezai, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402840
- Sponsor's protocol ID
- 2004963113
- Status last verified
- Apr 2025
- First submitted
- 22 May 2020
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT04402840
- Acronym / sponsor ID
- 2004963113
- Conditions
- Acute Respiratory Distress Syndrome, COVID-19
- Keywords
- Acute Respiratory Distress Syndrome, COVID-19, Autonomic Nervous System, Stellate Ganglion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block (SGB) | Experimental | Procedure: Stellate Ganglion BlockClinical Stellate ganglion block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Subjects with pre-existing cardiac failure
- Hemodynamic Instability
- Subject on Extracorporeal membrane oxygenation (ECMO)
- Anatomical inability to do a stellate block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion BlockThe procedure will be done at the bedside in the ICU without interfering with ongoing treatment. | Procedure or surgery | Stellate Ganglion Block (SGB) |
Primary outcome
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
3 secondary outcomes
Assessment of respiratory/ pulmonary function
Time frame: 3 Months
Radiographic criteria
Time frame: 3 Months
Cardiac function
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali R Rezai, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block in people with Acute Respiratory Distress Syndrome and COVID-19, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to SGB (time frame: 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.