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Stellate Ganglion Block for COVID-19-Induced Parosmia (Stella Trial)

Phase 3

Recruiting

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults age 18 to 70

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after sgb

Awards & highlights

Stella Trial Summary

This trial would assess if stellate ganglion blocks improve olfactory dysfunction from COVID-19, which can cause anxiety, depression, and even suicidal ideation. Few treatments exist, so this trial could provide a possible solution.

Who is the study for?

This trial is for adults aged 18-70 who had COVID-19 at least six months ago and are now experiencing parosmia. Participants must be able to communicate in English and score at least 15 on the DiSODOR scale. People with a history of smell disorders before COVID, certain medical conditions, or those using treatments for olfactory dysfunction cannot join.Check my eligibility

What is being tested?

The study is testing if a Stellate Ganglion Block (SGB) with Lidocaine improves smell function compared to a saline injection in people with long-term smell issues after COVID-19. It's a double-blind trial, meaning neither the participants nor the researchers know who gets Lidocaine or placebo.See study design

What are the potential side effects?

Possible side effects from SGB may include soreness where the needle was inserted, light-headedness shortly after the procedure, and rarely more serious complications like difficulty swallowing or changes in voice if nerves are affected.

Stella Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Stella Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after sgb

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after sgb

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after sgb for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)

Secondary outcome measures

Assessment of the Blind

Clinical Global Impression - Improvement Scale (CGI-I)

Clinical Global Impression - Severity Scale (CGI-S)

+6 more

Side effects data

From 2022 Phase 1 & 2 trial • 20 Patients • NCT05445921

100%

Horner syndrome

45%

Hoarseness

35%

Globus

25%

Brief lightheadedness

20%

Numbness of the face

20%

Mild shortness of breath

15%

Nasal congestion

15%

Pain at the injection site

15%

Fatigue

Cough

Headache

Arm heaviness

Palpitations

Weakness of the neck/back

Bruising of the injection site

Weakness of the arm

Tightness of the back

Chest heaviness

Tightness of the shoulder

100%

80%

60%

40%

20%

Study treatment Arm

Stellate Ganglion Block

Stella Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Stellate Ganglion BlockExperimental Treatment1 Intervention

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.

Group II: Placebo GroupPlacebo Group1 Intervention

The placebo sham injection will be performed in an identical fashion as the stellate ganglion block, with the exception of using 8 mL of 0.9% saline injection instead of Lidocaine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stellate Ganglion Block

2020

Completed Phase 2

~200

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,688 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions to enrolling in this research project?

"In order to fulfill the prerequisites for this clinical trial, participants must be aged 18 or over and no more than 70."

Answered by AI

Who is eligible to be a part of this clinical investigation?

"To be eligible for inclusion in this study, individuals must have parosmia and be between 18 to 70 years old. Approximately 44 volunteers are expected to take part in the trial."

Answered by AI

Are there any vacancies still available for enrollees in this clinical trial?

"According to the information published on clinicaltrials.gov, this experiment is no longer actively searching for patients as it was last updated in September of 2023. Although there are not any available spots left in this particular study, 6 other investigations are presently enrolling volunteers."

Answered by AI

Have the regulatory authorities approved of Stellate Ganglion Block?

"Our research team has surmised that Stellate Ganglion Block is safe, attributing a score of 3 to it. This conclusion was based on the fact that this trial had reached Phase 3 status; previously collected evidence demonstrating its efficacy and extensive data validating its safety being the primary motivators."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia

Leigh Sowerby 2024. "Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055270.

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