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

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

5 Participants Needed

Trial Summary

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.

Is the treatment generally safe for humans?

In a study involving 430 healthy volunteers, 13.5% experienced adverse events, with headaches being the most common. Severe adverse events occurred in 4.6% of participants, but there were no deaths or life-threatening events, suggesting a generally safe profile in humans. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing if a nerve-blocking procedure called Stellate Ganglion Block (SGB) is safe and helpful for patients with severe lung damage from COVID-19. The procedure involves injecting a local anesthetic near neck nerves to reduce inflammation and improve lung function. The goal is to see if this can slow down the worsening of lung injury in these patients. Stellate Ganglion Block (SGB) has been used for various conditions including PTSD, sudden hearing loss, and gastrointestinal function improvement.

Research Team

Ali R Rezai, MD

Principal Investigator

West Virginia University

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

Timeline

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

Treatment Details

Interventions

• SGB

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

2. England 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Factors affecting the causality assessment of adverse events following immunisation in paediatric clinical trials: An online survey. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]