Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction

NCT05445921 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 202207170
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic olfactory dysfunction from the COVID-19 pandemic is a growing public health crisis with up to 1.2 million people in the Unites States affected. Olfactory dysfunction impacts one's quality of life significantly by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform certain jobs. Olfactory dysfunction is also an independent predictor of anxiety, depression, and even mortality. While the pandemic has increased the interest by the scientific community in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Furthermore, patients impacted by "long COVID," or chronic symptoms after an acute COVID-19 infection, experience impairments other than olfactory and gustatory dysfunction, such as chronic dyspnea, impaired memory and concentration, and severe fatigue. These symptoms have been hypothesized to be a result of sympathetic positive feedback loops and dysautonomia. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies prior to the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. Therefore, we propose a single cohort prospective study to generate pilot data on the efficacy and safety of sequential stellate ganglion blocks for the treatment of COVID-19-induced olfactory dysfunction and other long COVID symptoms.

Conditions

Anosmia; Hyposmia; Parosmia; Olfactory Disorder

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression - Improvement (CGI-I) Score

  Participants will be asked about their change in olfactory dysfunction on a 7-point Likert scale from much better to much worse.

  5-10 days post SGB #1 and 1 month

Secondary Outcomes (3)

• University of Pennsylvania Smell Identification Test (UPSIT)

  baseline, 5-10 days, and 1 month

• Olfactory Dysfunction Outcomes Rating (ODOR)

  baseline, 5-10 days post SGB #1, and 1 month

• Clinical Global Impression - Severity (CGI-S) Score

  baseline, 5-10 days, and 1 month

Study Arms (1)

Stellate Ganglion Block

EXPERIMENTAL

The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.

Drug: Stellate Ganglion Block

Interventions

Stellate Ganglion Block DRUG

The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.

Also known as: mepivacaine

Stellate Ganglion Block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 to 70
• Diagnosis of COVID at least 12 months prior to study enrollment with self-reported olfactory dysfunction
• Objective olfactory dysfunction due to COVID-19 that has persisted despite viral recovery, as defined by the UPSIT (≤ 34 in women, ≤ 33 in men)
• Ability to read, write, and understand English

You may not qualify if:

• History of smell loss prior to COVID-19 infection
• History of conditions known to impact olfactory function:
• Chronic rhinosinusitis
• History of prior sinonasal or skull base surgery
• Neurodegenerative disorders (Parkinson's disease, Huntington's disease, Amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia)
• Currently using concomitant therapies specifically for the treatment of olfactory dysfunction
• Inability to tolerate a needle injection into the neck
• History of coexisting conditions that make SGB contraindicated:
• Unilateral vocal cord paralysis
• Severe COPD (FEV1 between 30-50% of predicted)
• Recent myocardial infarction within the last year
• Glaucoma
• Cardiac conduction block of any degree
• Currently taking blood thinners or antiplatelet agents
• Allergy to local anesthetic

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (26)

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Related Links

• The Efficacy of Stellate Ganglion Block in Olfactory Disorder Following Upper Respiratory Tract Infection
• The Efficacy of Stellate Ganglion Block in Sensorineural Anosmia Patients Unresponsive to Steroid Therapy

MeSH Terms

Conditions

Anosmia; Olfaction Disorders; COVID-19

Interventions

Mepivacaine

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Andrew Peterson, Resident Physician
• Organization: Washington University School of Medicine, Dept. of Otolaryngology - Head and Neck Surgery

pandrew@wustl.edu

314-362-5626

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nyssa Farrell, MD, Assistant Professor, Department of Otolaryngology - Head and Neck Surgery, Division of Rhinology and Anterior Skull Base Surgery

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 6, 2022
• Study Start: September 1, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: February 12, 2026
• Results First Posted: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)