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Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition

RecruitingPhase 4Ages 18 Years - anyAllUniversity Health Network, Toronto
NCT07468604 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 exacerb

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📋 Eligibility rules (as published)
Inclusion criteria 1. Age 18 years or older 2. PCC following COVID-19 infection with symptoms lasting for at least three months 3. Ability to read, write, and understand English 4. 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. 5. Patients should be stable on any PCC-related medications for at least four weeks. Exclusion criteria 1. History of co-existing conditions that are a contraindication for CSB: 1. Unilateral vocal cord paralysis; Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted value) 2. Recent myocardial infarction (within the last one year), Cardiac conduction block of any degree 3. Glaucoma 4. Infection or mass at injection site, bleeding disorders 2. Comorbid conditions that could confound study results, such as: 1. Active autoimmune disorders 2. Pre-existing autonomic dysfunction (e.g. POTS, IST, and CRPS) prior to COVID-19 3. Untreated psychiatric conditions (e.g. severe anxiety or PTSD requiring medication adjustments during the study period) 3. Recent history of major surgery or cerebrovascular events within the last three months 4. Allergy to local anesthetic; Inability to extend the neck for any reason (e.g. severe arthritis) 5. History of prior stellate ganglion block
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What it tests

  • 5 mL of 0.25% bupivacaine with epinephrine (1:200,000)
  • Placebo (Saline) Control
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Where

2 sites
Women's College Hospital
Toronto, Canada
Toronto Western Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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