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NCT06253806: SGB

Stellate Ganglion Block for COVID-induced Parosmia

Completed Phase 2 Results posted Last updated 10 November 2025
What this trial tests

Phase 2 trial testing Stellate Ganglion Block in COVID-19-Induced Parosmia in 48 participants. Completed in 16 September 2024.

Timeline
25 October 2023
Primary endpoint
16 September 2024
16 September 2024

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment48
Start date25 October 2023
Primary completion16 September 2024
Estimated completion16 September 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 70, any sex, with COVID-19-Induced Parosmia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Parosmia Olfactory Dysfunction Outcomes Rating Primary · 1-mo outcome and 3-mo outcome

The primary outcome of the study is to determine the efficacy of a stellate ganglion block (SGB) in improving parosmia-related quality of life compared to a saline injection placebo. The instrument contains 28 total items with each scored on a 5-point Likert scale from 0 (no difficulty) to 4 (complete difficulty or very frequent bother). Higher total scores indicate a greater degree of dysfunction and limitation. The minimal clinically important difference (MCID) for DisODOR being 15 points.

1-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block9-19 – 54
Placebo: Sham Injection9-13 – 82
3-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block14-21 – 59
Placebo: Sham Injection11-16 – 60
Clinical Global Impression - Severity Scale (CGI-S) Smell Loss Secondary · 1-mo and 3-mo

The Clinical Global Impression - Improvement Scale (CGI-I) for smell loss (parosmia) is used to measure the overall response to treatment by assessing changes in the clinical condition compared to before the stellate ganglion block. It uses a 7-point Likert scale with the following response options: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Participants who report "slightly better now than before" or

1-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block8
Placebo: Sham Injection4
Experimental: Stellate Ganglion Block22
Placebo: Sham Injection11
Experimental: Stellate Ganglion Block1
Placebo: Sham Injection1
3-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block13
Placebo: Sham Injection6
Experimental: Stellate Ganglion Block13
Placebo: Sham Injection10
Experimental: Stellate Ganglion Block4
Placebo: Sham Injection0
Long-COVID Questionnaire Secondary · 1 month, 3 months

At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale. Total scores range from 0-77, with higher scores being worse and lower scores being better.

1-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block4421 – 68
Placebo: Sham Injection4511 – 69
3-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block4416 – 74
Placebo: Sham Injection4411 – 53
Olfaction Catastrophizing Scale (OCS) Secondary · 1 month, 3 months

Participants will be asked to complete the OCS, which measures the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52. Participants will complete the OCS at each study visit to assess the degree of olfactory-related catastrophizing over time.

1-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block8-6 – 32
Placebo: Sham Injection6-5 – 38
3-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block7-13 – 31
Placebo: Sham Injection5-8 – 33
Hospital Anxiety and Depression Scale (HADS) Secondary · 1 month, 3 months

Participants will be asked to complete the HADS, which screens for both anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression.

1-mo HADS anxiety
GroupValue95% CI
Experimental: Stellate Ganglion Block1-6 – 10
Placebo: Sham Injection1-5 – 10
3-mo HADS anxiety
GroupValue95% CI
Experimental: Stellate Ganglion Block1-8 – 18
Placebo: Sham Injection1-8 – 8
1-mo HADS depression
GroupValue95% CI
Experimental: Stellate Ganglion Block1-7 – 10
Placebo: Sham Injection1-4 – 8
3-mo HADS depression
GroupValue95% CI
Experimental: Stellate Ganglion Block8-6 – 32
Placebo: Sham Injection3-7 – 7
Patient Satisfaction With Treatment Secondary · 1 mo, 3-mo

Participants will be asked at 1 month "Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?" with possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied.

1-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block8
Placebo: Sham Injection5
Experimental: Stellate Ganglion Block10
Placebo: Sham Injection4
Experimental: Stellate Ganglion Block13
Placebo: Sham Injection7
3-mo
GroupValue95% CI
Experimental: Stellate Ganglion Block11
Placebo: Sham Injection5
Experimental: Stellate Ganglion Block1
Placebo: Sham Injection5
Experimental: Stellate Ganglion Block18
Placebo: Sham Injection6
Assessment of the Blind Secondary · during first visit

Immediately after the injection, participants will be asked "Which intervention do you think you received?" with answer choices of 1) Mepivacaine (active medication) or 2) Saline (placebo). It is performed immediately after the initial injection during the first visit, just prior to discharge.

1-mo blind assessment
GroupValue95% CI
Experimental: Stellate Ganglion Block18
Placebo: Sham Injection14
3-mo blind assessment
GroupValue95% CI
Experimental: Stellate Ganglion Block12
Placebo: Sham Injection4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental: Stellate Ganglion Block
Serious: 0/31 (0%)
Deaths: 0/31
Placebo: Sham Injection
Serious: 0/16 (0%)
Deaths: 0/16
Other adverse events (4 terms — click to expand)

ReactionSystemExperimental: Stellate Gan…Placebo: Sham Injection
transient voice hoarsenessGeneral disorders
nasal congestionGeneral disorders
headache or migraineGeneral disorders
lightheadedness or dizzinessGeneral disorders

Data from ClinicalTrials.gov NCT06253806 adverse events section.

Sponsor's own description

Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a growing public health crisis with up to 1.2 million people in the United 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 loss is also an independent predictor of anxiety, depression, and even mortality. Recent research by our group (unpublished data) and suggests that parosmias, moreso than hyposmias, can result in increased rates of anxiety, depression, and even suicidal ideation. 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. Persistent symptoms after an acute COVID-19 infection, or "Long COVID" 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. A previous pilot study using stellate ganglion blocks of 20 participants with persistent COVID-19 olfactory dysfunction resulted modest improvements in subjective olfactory function, smell identification, and olfactory-specific quality-of-life, but it lacked a control group. Therefore, we propose a double-blinded, placebo-controlled randomized clinical trial assessing the efficacy of a stellate ganglion block versus saline injection in a total of up to 140 participants with persistent COVID-19-associated olfactory dysfunction.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Stellate Ganglion Block for the Treatment of COVID-19-Induced Parosmia: A Randomized Clinical Trial.
    Farrell NF, Crock LW, Islam A, Adkins D, et al · · 2025 · cited 3× · PMID 40504522 · DOI 10.1001/jamaoto.2025.1304

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