Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID

NCT05638620 | Completed Phase 1 FDA Drug

• 1 other identifier: BRANY # 22-02-733-993
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.

Conditions

Post Acute COVID-19 Syndrome; Long COVID; Long Covid19; COVID-19 Recurrent; Post-Acute COVID-19; Post-Acute COVID-19 Infection; SARS-CoV2 Infection; Post Acute Sequelae of COVID-19; Dysautonomia; Dysautonomia Like Disorder; Dysautonomia Orthostatic Hypotension Syndrome; Post COVID-19 Condition; Post-COVID Syndrome; Post COVID-19 Condition, Unspecified; Post-COVID-19 Syndrome

Keywords

COVID; long covid; SARS-COV2; COVID-19; long COVID-19; post covid; dysautonomia; stellate ganglion block; dual sympathetic block; SGB; DSB

Outcome Measures

Primary Outcomes (8)

• Patient-Reported Outcomes: PROMIS-29 Score

  The primary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve patient-reported outcomes of depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities status. These domains are measured as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS-29) total scores between baseline and 4 weeks

  1 month

• Depression

  PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

  1 month

• Anxiety

  PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

  1 month

• Physical function

  PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

  1 month

• Pain interference

  PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

  1 month

• Fatigue

  PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

  1 month

• Sleep disturbance

  PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

  1 month

• Ability to participate in social roles and activities status

  PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

  1 month

Secondary Outcomes (1)

• Autonomic Symptoms: COMPASS-31 Score

  1 month

Study Arms (1)

Active

EXPERIMENTAL

This is a non-randomized, non-blinded study. Participants eligible for this study will receive active treatment. Dual Sympathetic Blocks of the stellate ganglion are minimally- invasive outpatient procedures performed under monitored care anesthesia (light sedation). Under ultrasound visualization, a small needle is guided into the neck region that contains the stellate ganglion nerve cluster at C6-C7. Once the needle position is confirmed, a local anesthetic (7 cc of 0.5% bupivacaine/Marcaine) is injected around the stellate ganglion by the Principal Investigator. This procedure is repeated at the C3-C4 level to block the superior cervical ganglion nerve cluster (3 cc of 0.5% bupivacaine/Marcaine).

Drug: stellate ganglion block with 0.5% bupivacaine

Interventions

stellate ganglion block with 0.5% bupivacaine DRUG

The stellate ganglion block is being done on both sides of the neck. The stellate ganglion block will be performed on the right side at the first visit. The procedure will be repeated on the left side one week after the first injection. This study is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug. Similar to a phase 1 clinical trial, the main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms. As a general rule, phase 1 studies require a low number of patients, typically 12-20 subjects. There is considerable uncertainty regarding long COVID as a disease state, so data from even small numbers of patients in a well-designed clinical trial will make steps towards reducing that uncertainty.

Also known as: Dual Sympathetic Block, Stellate ganglion nerve block

Active

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing
• Persistent symptoms that continue four or more weeks after the start of a COVID-19 infection
• Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31). The COMPASS-31 assesses 6 domains of autonomic symptoms: Orthostatic Intolerance, Vasomotor, Secretomotor, Gastrointestinal, Bladder, and Pupillomotor.
• Quantified pain symptoms of pain interference or pain intensity as reported by the patient on the screener Patient-Reported Outcomes Measurement Information System (PROMIS-29)

You may not qualify if:

• Under age 18
• Prior SGB
• Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine/Marcaine)
• Pregnancy
• Current anticoagulant use
• History of a bleeding disorder
• History of glaucoma
• Infection or mass at injection site
• For the consistency of this study, patients who deny all autonomic symptoms on the COMPASS-31 or pain symptoms on the PROMIS-29 will also be excluded

Sponsors & Collaborators

• Jonathann Kuo, MD: lead

Study Sites (1)

Hudson Medical

New York, New York, 10014, United States

Location

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  BACKGROUND

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Related Links

• Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS). ClinicaTrials.gov identifier NCT04402840. Updated November 3, 2020. Accessed October 11, 2022.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Autonomic Nervous System Diseases; Dysautonomia like disorder; Shy-Drager Syndrome

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Multiple System Atrophy; Primary Dysautonomias; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jonathann Kuo, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Model Details: This will be a single-site, non-randomized, open-label, prospective study to evaluate the effects of bilateral Dual Sympathetic Blocks (DSB) on the dysautonomic symptomatology of Post-Acute Sequelae of SARS-CoV-2 (PASC). Patients will be evaluated for pain interference and dysautonomic symptomatology by the PROMIS-29 and COMPASS-31 scores at 0,1, and 4 weeks.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 6, 2022
• Study Start: January 3, 2023
• Primary Completion: June 15, 2023
• Study Completion: December 30, 2023
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)