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A Randomized Controlled Trial for Cervicothoracic Sympathetic Chain Block Against Sham Injection Evaluation for Post COVID Condition: the CeASE RCT

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Post-COVID Condition (PCC) affects roughly 2.1 million Canadians, carrying an annual economic burden of CAD $7.8-50.6 billion. It presents across multiple organ systems with symptoms including fatigue, brain fog, palpitations, and orthostatic intolerance, at an annual cost of CAD $1,675-$7,340 per case. A key mechanism underlying many treatment-resistant PCC symptoms appears to be dysautonomia abnormal autonomic nervous system function driven by immune-mediated sympathetic overactivity. Persistent inflammation (cytokine storms, T/B-cell dysfunction, microclots) sustains sympathetic hyperactivity, which in turn perpetuates systemic inflammation and sickness behaviors resembling PCC symptoms. Current treatments including beta blockers, ivabradine, fludrocortisone, and rehabilitation are limited by variable responses, side effects, and the complication of post-exertional symptom exacerbation. Emerging therapies (SSRIs, low-dose naltrexone, antihistamines, HBOT) show promise but lack robust trial evidence. Cervicothoracic sympathetic chain block (CSB) a local anesthetic block of the cervical and upper thoracic sympathetic ganglia is a promising intervention that reduces sympathetic outflow, improves cerebral blood supply, and lowers pro-inflammatory cytokines. Small observational studies (16 studies, 224 patients) show benefit for PCC symptoms, but all lack placebo controls and have significant methodological heterogeneity. The proposed study aims to fill this gap with a double-blind, placebo-controlled RCT to rigorously evaluate CSB's efficacy, magnitude of benefit, and durability in PCC patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• PCC following COVID-19 infection with symptoms lasting for at least three months

• Ability to read, write, and understand English

• Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31), i.e. a COMPASS-31 score greater than 0. COMPASS-31 assesses 6 domains of autonomic symptoms: Orthostatic Intolerance, Vasomotor, Secretomotor, Gastrointestinal, Bladder, and Pupillomotor.

• Patients should be stable on any PCC-related medications for at least four weeks.

Locations
Other Locations
Canada
Toronto Western Hospital
RECRUITING
Toronto
Toronto Western Hospital/UHN
RECRUITING
Toronto
Women's College Hospital
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Emad Al Azazi, MD, PhD
emad.al-azazi@uhn.ca
4166035800
Time Frame
Start Date: 2026-05-19
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 78
Treatments
Experimental: Active group
The active group will have cervical sympathetic block (CSB) on both the left and right sides using up to 5 mL of 0.25% bupivacaine with epinephrine (1:200,000).
Placebo_comparator: Sham group
The sham group will have cervical sympathetic block (CSB) on both the left and right sides using up to 5 ml of normal saline (0.9% NaCl).
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov

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