Stellate Ganglion Block for Coronavirus

Overseen By Padma Tirumalai, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Disqualifiers: Cardiac failure, Hemodynamic instability, ECMO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of Stellate Ganglion Block (SGB) for individuals with severe lung problems, specifically Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19. The researchers aim to determine if SGB can improve lung function in these patients. This trial may suit those diagnosed with COVID-19 ARDS, receiving critical care, and showing lung issues on a CT or chest X-ray. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Stellate Ganglion Block (SGB) is safe for patients with severe lung injury ARDS due to COVID-19 infection?

Research shows that the Stellate Ganglion Block (SGB) is generally safe and well-tolerated. Studies involving patients with severe conditions like PTSD (post-traumatic stress disorder) and PHN (postherpetic neuralgia) have found SGB to be a safe procedure. Most patients undergo the treatment without major issues.

However, some studies mention rare complications. For instance, one case involved temporary cessation of breathing, which was quickly treated. Other minor issues can include temporary hoarseness due to nerve effects. Despite these rare events, SGB is considered safe overall, with most people experiencing no significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for COVID-19 Acute Respiratory Distress Syndrome (ARDS), which often involves mechanical ventilation and supportive oxygen therapy, Stellate Ganglion Block (SGB) acts on a different mechanism by targeting the autonomic nervous system. This approach potentially reduces inflammation and improves lung function more directly. Researchers are excited because SGB could offer a new way to alleviate ARDS symptoms without the side effects associated with more invasive treatments, providing a quicker and less burdensome relief for patients.

What evidence suggests that SGB is effective for ARDS due to COVID-19?

Research has shown that Stellate Ganglion Block (SGB), the treatment under study in this trial, might help with conditions like anxiety, depression, and pain. Studies involving individuals with PTSD (post-traumatic stress disorder) found that many experienced rapid improvement after receiving SGB, with improvement rates between 70% and 75%. Other research indicates that SGB can also assist people with heart rhythm problems, leading to lower death rates. Although SGB is not yet proven to help with COVID-19-related ARDS (acute respiratory distress syndrome), these findings suggest it might improve overall health and reduce stress-related symptoms. ^{5 6 7 8 9}

Who Is on the Research Team?

Ali R Rezai, MD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Stellate Ganglion Block (SGB) to assess safety and efficacy in ARDS

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of respiratory, cardiac, and radiographic criteria

3 months

What Are the Treatments Tested in This Trial?

Interventions

• SGB

How Is the Trial Designed?

Group I: Stellate Ganglion Block (SGB) Experimental Treatment 1 Intervention

Clinical Stellate ganglion block

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Published Research Related to This Trial

In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).

Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. Sibille, M., Deigat, N., Olagnier, V., et al.[2019]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

In the ICON8 ovarian cancer clinical trial, 51,019 adverse events were reported, but only 61% of serious adverse events were matched to existing adverse events, indicating a significant gap in safety reporting.

Re-analyzing safety data by including serious adverse events increased the detection of grade 3 or worse safety events, highlighting the importance of comprehensive safety data collection for accurate risk assessment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. James, EC., Dunn, D., Cook, AD., et al.[2021]

A survey of 140 professionals with vaccine trial experience revealed significant inconsistencies in assessing whether serious adverse events (SAEs) were related to immunizations, with only 28% of respondents linking leukaemia to a live RSV vaccine, while 74% linked juvenile idiopathic arthritis (JIA) to a group A streptococcal vaccine.

The type of classification system used (two options vs. three options) significantly affected the likelihood of classifying SAEs as related to immunization, highlighting the need for standardized SAE classification systems across clinical trials to improve consistency in pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting the causality assessment of adverse events following immunisation in paediatric clinical trials: An online survey. Voysey, M., Tavana, R., Farooq, Y., et al.[2017]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK442253/

Evidence Brief: Effectiveness of Stellate Ganglion Block for ... In the RCT, the range of mean percent PTSD improvement after one round of SGB was 5.4% to 14.7%, and was 12.1% to 21.2% after the second round, which was no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10029323/

A Review of Stellate Ganglion Block as an Adjunctive ... Secondary outcomes showed clinically significant improvements in anxiety, depression, pain scores, and mental and physical functioning [31].

3. hsrd.research.va.gov hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no124&eBriefTitle=Effectiveness+of+Stellate+Ganglion+Block+for+Treatment+of+PTSD

Effectiveness of Stellate Ganglion Block for Treatment of PTSD In the aforementioned case series, SGB for PTSD had high rates of rapid clinical improvement in PTSD symptoms (70% to 75%). However, findings from the first RCT ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X24000082

A Multicenter Study of Stellate Ganglion Block as ... The largest study of SGB showed that, when successful, SGB was associated with a significant decrease in mortality among patients with refractory arrythmias.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05107752

Stellate Ganglion Block to Augment Trauma-focused ... The primary objective of this project is to examine if stellate ganglion block (SGB) improves outcomes among military personnel and veterans receiving cognitive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4601906/

Safety and Patient Acceptability of Stellate Ganglion ... The SGB procedure for PTSD is a safe, well-tolerated, and acceptable treatment adjunct in the management of severe symptoms associated with chronic treatment- ...

7. nature.com nature.com/articles/s41598-025-91847-7

Effectiveness and safety of stellate ganglion block with ... Clinical practice and literature have demonstrated that SGB is safe and effective for PHN. However, some patients do not experience satisfactory ...

8. academic.oup.com academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.434/7838993

Efficacy and safety of ultrasound guided stellate ganglion block Only 1 (1%) major complication occurred (respiratory arrest), that was quickly and effectively treated with lipid emulsion, while minor ...

9. wjgnet.com wjgnet.com/2307-8960/full/v11/i10/2160.htm

Treatment of stellate ganglion block in diseases There have been no changes and progress in the clinical application of SGB since the 1830s due to several potential risks, including hematoma ...