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

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

Interventions

DRUG

stellate ganglion block with 0.5% bupivacaine

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.

Sponsors & Collaborators

• Jonathann Kuo, MD

  lead OTHER

Principal Investigators

• Jonathann Kuo, MD · Medical Director

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-03

Primary Completion

2023-06-15

Completion

2023-12-30

FDA Drug

Yes

Countries

• United States

Study Locations