Stellate Ganglion Block for Long COVID Symptoms: A Randomized Controlled Trial (STAR-CO)

February 5, 2026 updated by: Marie-Claude Lehoux, Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

Effect of Stellate Ganglion Block Treatment on Long COVID Symptoms: A Single-Blind, Single-Center Randomized Controlled Trial (STAR-CO)

This single-center, randomized, controlled, single-blind clinical trial evaluates whether a stellate ganglion block (SGB) using bupivacaine can improve persistent symptoms in adults with long COVID. Participants are assigned in a 1:1 ratio to receive either an ultrasound-guided right-sided SGB or a placebo saline injection delivered to the sternocleidomastoid muscle. After the intervention, participants are followed for 26 weeks with scheduled evaluations that include symptom questionnaires and functional tests.

The study assesses changes in functional status, fatigue, cognitive complaints, quality of life, dyspnea, lower-limb endurance, and orthostatic tolerance over time. Safety is monitored throughout all follow-up visits. Approximately 40 participants meeting predefined eligibility criteria will be enrolled. This trial seeks to determine whether a single stellate ganglion block has an effect on persistent long-COVID symptoms compared with placebo.The results will help determine the therapeutic value of SGB in the management of long COVID and inform future research and clinical practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Recruiting
        • Centre hospitalier affilié universitaire régional
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Hakim, MD
        • Principal Investigator:
          • Andrés Felipe Fil Blanco, MD
        • Principal Investigator:
          • Magali Brousseau-Foley, MD, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years and older
  • Positive COVID-19 test confirmed by RT-PCR, antibody test, or antigen test at least 3 months prior to randomization, OR presumed COVID-19 evaluated by the site investigator (no positive test required) with an acute illness occurring after October 15, 2019 and at least 3 months prior to randomization.
  • Persistent symptoms ≥12 weeks after onset of acute COVID-19 AND symptoms lasting at least 2 months. The onset date is defined as the earliest of: date of first positive test, date of first symptoms
  • Post-COVID Functional Status Scale score ≥2.
  • Persistent dyspnea ≥2/4 on the mMRC scale at least 12 weeks post-infection.
  • Persistent COVID-19-related symptoms at the time of randomization.
  • If taking medications for fatigue or cognition (e.g., sildenafil, modafinil, armodafinil, guanfacine, N-acetylcysteine, stimulants for ADHD), these must have been initiated and stable for ≥4 weeks prior to randomization. Participants are asked not to stop or alter these medications during the study if possible.
  • Able and willing to provide written informed consent.
  • Able to read and understand French.

Exclusion Criteria:

  • Prior diagnosis of myalgic encephalomyelitis (ME) or fibromyalgia
  • Being on sick leave or disability at the time of the original acute COVID-19 infection.
  • Pregnancy or breastfeeding.
  • Myocardial infarction within the last 12 weeks.
  • Use of anticoagulant therapy.
  • Glaucoma.
  • Emphysema requiring home oxygen.
  • Cardiac conduction abnormalities.
  • Known hypersensitivity to bupivacaine.
  • Previous stellate ganglion block (SGB) procedure.
  • Any condition that, in the judgment of the medical investigator, makes the patient not a candidate for the proposed treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stellate Ganglion Block with Bupivacaine
Participant receives a right-sided stellate ganglion block under ultrasound guidance, using bupivacaine, performed by an anesthesiologist.
Procedure: Stellate Ganglion Block (Bupivacaine)
A single ultrasound-guided stellate ganglion block is administered on the right side of the neck under sterile conditions by an anesthesiologist. The needle is positioned between the longus colli muscle and the right carotid artery, and 7 mL of 0.5% bupivacaine is injected. Correct placement is verified by ultrasound and confirmed clinically by the expected appearance of Claude Bernard-Horner syndrome following the injection. Participants are observed for approximately 30 minutes after the procedure.
Placebo Comparator: Placebo Neck Injection
Participant receives a saline injection into the sternocleidomastoid muscle under the same conditions.
Procedure: placebo saline injection
A single placebo injection of 6-8 mL of 0.9% normal saline is administered into the right sternocleidomastoid muscle. The procedure uses the same patient positioning, sterile preparation, and ultrasound guidance as the active arm; however, the needle is intentionally placed in the muscle, away from the stellate ganglion, and does not produce a stellate ganglion block (i.e., cannot cause Claude Bernard-Horner syndrome).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-COVID-19 Functional Status Scale (PCFS)
Time Frame: 4 weeks after the intervention
The PCFS measures limitations in daily functioning related to persistent post-COVID-19 symptoms. Scores range from 0 (no functional limitation) to 4 (severe functional limitation). Assesses changes in functional status over time.
4 weeks after the intervention
Fatigue Severity Scale (FSS)
Time Frame: 4 weeks after the intervention
The FSS is a validated 9-item questionnaire assessing the impact of fatigue on daily activities, motivation, and functioning. Each item is scored from 1 to 7; higher scores indicate greater fatigue severity. Clinically significant change is defined as ≥0.45 points.
4 weeks after the intervention
Brain Fog Scale (BFS)
Time Frame: 4 weeks after the intervention
The BFS is a 23-item questionnaire evaluating cognitive symptoms associated with Long COVID, including mental fatigue, cognitive clarity, logical thinking, and concentration. Total scores range from 0 to 92, with higher scores indicating more severe cognitive impairment.
4 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (SF-36)
Time Frame: 4 weeks after the intervention
The SF-36 is a validated 36-item questionnaire assessing eight domains of health-related quality of life, including physical functioning, limitations due to physical or emotional problems, pain, general health, vitality, social functioning, and mental health. Higher scores reflect better perceived health and functioning.
4 weeks after the intervention
Dyspnea Severity (mMRC Scale)
Time Frame: 4 weeks after the intervention
The modified Medical Research Council (mMRC) Dyspnea Scale is a 0-4 grading system that assesses the degree to which breathlessness limits daily activities. Higher grades indicate greater functional limitation due to dyspnea. It is the only validated French-language scale measuring dyspnea in daily activities.
4 weeks after the intervention
Lower-Limb Muscle Endurance (1-Minute Sit-to-Stand Test)
Time Frame: 4 weeks after the intervention
The 1-Minute Sit-to-Stand Test (1STST) measures lower-limb muscular endurance by counting the number of sit-to-stand repetitions a participant completes in one minute from a standard chair without armrests. It is reliable, sensitive, and well-tolerated in populations with impaired physical capacity. Higher counts indicate better endurance.
4 weeks after the intervention
Orthostatic Intolerance (NASA Lean Test)
Time Frame: 4 weeks after the intervention
The NASA Lean Test assesses orthostatic intolerance by measuring heart rate and blood pressure changes during 10 minutes of standing with the back supported against a wall. Results help identify symptoms such as dizziness, palpitations, or light-headedness related to positional changes. If a participant cannot complete 10 minutes, the test is still considered valid.
4 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-898
  • 1028 (Registry Identifier: Base de données des projets de recherche du CIUSSS-MCQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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