Using Stellate Ganglion Block with Lidocaine to Treat COVID-19-Induced Parosmia

Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia: Double-Blinded, Placebo-Controlled Randomized Clinical Trial

This study is testing if a special injection can help people who lost their sense of smell after having COVID-19 feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT06055270 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Stellate Ganglion Block (SGB) with Lidocaine in treating parosmia, a condition affecting the sense of smell, in individuals who have experienced COVID-19. Participants aged 18 to 70, diagnosed with COVID-19 at least six months prior, will be randomly assigned to receive either the SGB treatment or a placebo. The study will involve baseline assessments and follow-up evaluations at 1, 3, and 12 months to measure changes in olfactory function and related psychological impacts. The trial is designed to be double-blinded and placebo-controlled to ensure the reliability of results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who have been diagnosed with COVID-19 at least six months prior and report experiencing parosmia.

Not a fit: Patients who had a history of smell loss prior to COVID-19 or have conditions that impact olfactory function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from parosmia due to COVID-19.

How similar studies have performed: While there is limited research on the use of SGB for olfactory dysfunction, the approach is novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Adults age 18 to 70
2. Diagnosis of COVID-19 at least 6 months prior to study enrollment with self-reported parosmia
3. Ability to read, write, and understand English
4. Score of at least 15 on DiSODOR

Exclusion Criteria:

1. History of smell loss or change prior to COVID-19 infection
2. History of conditions known to impact olfactory function:

   1. Chronic rhinosinusitis
   2. History of prior sinonasal or skull base surgery
   3. Neurodegenerative disorders (Parkinson's disease, Huntington's disease, Amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia)
3. Currently using concomitant therapies specifically for the treatment of olfactory dysfunction
4. Inability to tolerate a needle injection into the neck
5. History of coexisting conditions that make SGB contraindicated:

   1. Unilateral vocal cord paralysis
   2. Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted)
   3. Recent myocardial infarction within the last year
   4. Glaucoma
   5. Cardiac conduction block of any degree
6. Currently taking blood thinners or antiplatelet agents
7. Allergy to local anesthetic
8. Inability to extend the neck for any reason (e.g., severe arthritis)

Where this trial is running

London, Ontario

• St. Joseph's Hospital London — London, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Lanette Friesen-Waldner, Ph.D

Conditions Parosmia; Long-COVID; Olfactory disfunction; smell; olfaction; anosmia; bad smell