SGB for COVID-induced Parosmia

Phase 2

Completed

• Conditions: COVID-19-Induced Parosmia
• Interventions: Drug: Placebo Sham Injection; Drug: Stellate Ganglion Block

• Registration Number: NCT06253806
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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 perf...

Detailed Description

One of the hallmark symptoms of infection with SARS-CoV-2 is olfactory dysfunction (OD). While the majority of patients recover from COVID dysosmia, up to 15%-25% have long-term hyposmia and it is estimated that up to 1.2 million people in the United States will experience chronic OD from the COVID-19 pandemic. A unique feature of COVID-19-associated OD is t...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-10-25
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Status Verified: 2024-07
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Adults age 18 to 70
2. Diagnosis of COVID 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 40 on DiSODOR during screening and at least 25 during Visit 1

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Exclusion Criteria

1. History of smell loss or change prior to COVID-19 infection

2. History of conditions known to impact olfactory dysfunction

   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 COPD (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, including aspirin >81mg.

7. Allergy to local anesthetic

8. Inability to extend the neck for any reason (e.g., severe arthritis)

9. History of prior stellate ganglion block

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo: Sham Injection	Placebo Sham Injection	The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Experimental: Stellate Ganglion Block	Stellate Ganglion Block	The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.

Primary Outcome Measures

Name	Time	Method
Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)	Baseline, 1 month, 3 months	Participants will be asked to complete the DiSODOR, which is a patient-reported outcome measure assessing physical problems, functional limitations, and emotional consequences of parosmia. The minimal clinically important difference is 15.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Severity Scale (CGI-S)	Baseline	Participants will be asked to complete the CGI-S, which will assess the baseline severity of their parosmia on a 5-point Likert scale.
Clinical Global Impression - Improvement Scale (CGI-I)	1 month, 3 month	Participants will be asked to the complete the CGI-I, which assesses change in their parosmia on a 7-point Likert scale from much better to much worse. Responders are defined as those who report "slightly better now than before" or greater.
University of Pennsylvania Smell Identification Test (UPSIT, Sensonics, New Jersey)	Baseline	Participants will be asked to complete the UPSIT, which is the gold standard test of olfactory identification. The test consists of 40 "scratch and sniff" items associated with multiple choice questions. The normalcy benchmark is defined as a score of \>34 in women and \>33 in men. The minimal clinically important difference of the UPSIT is 4.
Olfaction Catastrophizing Scale (OCS)	Baseline, 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.
Long-COVID Questionnaire (LCQ)	Baseline, 1 month, 3 months	Participants will be asked to complete the LCQ, which assesses the burden of 11 different symptoms associated with Long-COVID. It measures the severity of each problem on a 5-point Likert scale, with improvement options being based on the CGI-I 7-point Likert scale.
Hospital Anxiety and Depression Scale (HADS)	Baseline, 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 scr...
Pre-Intervention Expectations	Baseline	Participants will be asked at baseline "How confident are you that the stellate ganglion block will improve your smell loss or smell distortion?" with possible answer choices: Not at all, Slightly confident, Somewhat confident, Very confident, Extremely confident.
Patient Satisfaction with Treatment	1 month, 3 months	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.; ...
Assessment of the Blind	Baseline	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).

Trial Locations

Locations (1)

Nyssa Fox Farrell; 🇺🇸 Saint Louis, Missouri, United States