78 Participants NeededMy employer runs this trial

Cervicothoracic Sympathetic Block for Long COVID

(CeASE Trial)

Recruiting at 2 trial locations
EA
Overseen ByEmad Al Azazi, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University Health Network, Toronto
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Cervicothoracic Sympathetic Block (CSB) to determine its effectiveness for Long COVID. Long COVID can cause symptoms like tiredness, brain fog, and heart palpitations, often linked to autonomic nervous system issues, which control automatic body functions. CSB uses a local anesthetic to calm overactive nerves, potentially reducing inflammation and improving symptoms. The study will compare the effects of CSB to a placebo (a harmless substance used for comparison) to evaluate its efficacy. Individuals who have had COVID-19 and continue to experience these symptoms for at least three months might be suitable candidates for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, helping researchers understand its benefits for more patients.

What is the safety track record for Cervicothoracic Sympathetic Block (CSB)?

Earlier studies have shown that a treatment called cervicothoracic sympathetic block (CSB) may help with long COVID symptoms. Research suggests that CSB works by blocking certain nerve signals, potentially reducing inflammation and improving blood flow to the brain.

Small studies involving 224 patients have examined CSB's effects. These studies indicate that the treatment might alleviate symptoms like tiredness, difficulty thinking clearly, and heart palpitations. However, these studies did not use a placebo for comparison, which could introduce bias in the results.

Regarding safety, CSB is generally well-tolerated. Previous patients reported few side effects, but more thorough studies are needed to confirm this. The current trial's later stage suggests some evidence supports the treatment's safety. However, joining a trial always involves potential risks, so discussing any concerns with the trial team is advisable.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Cervicothoracic Sympathetic Block (CSB) because it offers a novel approach to managing Long COVID symptoms. Unlike traditional treatments such as antivirals or corticosteroids that address viral load or inflammation, CSB targets the nervous system by blocking nerve signals. This method uses bupivacaine with epinephrine to potentially reduce persistent symptoms like fatigue and brain fog by modulating autonomic nervous system activity. This could provide faster relief and a different mechanism of action than current treatment options.

What evidence suggests that Cervicothoracic Sympathetic Block could be an effective treatment for Long COVID?

This trial will compare the effects of cervicothoracic sympathetic block (CSB) with a sham procedure for treating Long COVID symptoms. Studies have shown that treatments like CSB can help reduce symptoms in people with Long COVID. In one study, 86% of patients felt better after receiving a similar treatment called stellate ganglion block (SGB). CSB blocks nerve signals that keep the body in a "fight or flight" state, helping to calm the body and reduce inflammation. This is important because Long COVID symptoms often link to an overactive nervous system. While early studies are promising, more detailed research is needed to confirm these findings.12346

Who Is on the Research Team?

AB

Anuj Bhatia, MD, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have had long-lasting symptoms (over 3 months) after COVID-19, especially problems with their autonomic nervous system like dizziness when standing, digestive issues, or abnormal sweating. Participants must be able to understand English and have stable medication use for at least four weeks.

Inclusion Criteria

I am 18 years old or older.
I have reported at least one type of autonomic symptom on the COMPASS-31 screener.
I have been on the same PCC-related medications for at least four weeks.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cervicothoracic sympathetic chain block (CSB) or sham injection to evaluate efficacy in treating post-COVID condition symptoms

4 weeks
Weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cervicothoracic Sympathetic Block (CSB)

Trial Overview

The study compares a nerve block procedure using bupivacaine with epinephrine to a placebo (sham) injection. It aims to see if blocking certain nerves in the neck and upper chest can improve post-COVID symptoms related to nervous system dysfunction. The trial is double-blind and placebo-controlled.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active groupExperimental Treatment1 Intervention
Group II: Sham groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Effectiveness of Dual Sympathetic Blocks for ... - PMC - NIH

Effectiveness of Dual Sympathetic Blocks for Sympathetically Mediated Symptoms in Post-acute Sequelae of SARS-CoV-2 (PASC): An Open-Label, Non- ...

Study Details | NCT05638620 | Dual Sympathetic Blocks ...

The case series reported sustained positive clinical outcomes for two Long COVID patients after treatment with SGB, identifying the pathophysiology for their ...

Development of a definition of postacute sequelae of SARS ...

To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections.

Post-Acute Sequelae of SARS-CoV-2 Infection Among ...

This report describes identification of post-acute sequelae in recovered COVID-19 patients in Long Beach, California.

Cervicothoracic Sympathetic Block Evaluation for Post ...

There is a range of symptoms that are encompassed within the syndrome of PCC, including fatigue, shortness of breath, chest pain, palpitations, headache, ...

Pathogenic mechanisms of post-acute sequelae of SARS- ...

This review addresses potential mechanisms and hypotheses that connect SARS-CoV-2 infection to long-term health consequences. Comparisons between PASC and ...