Cervicothoracic Sympathetic Block for Post-CCOVID Condition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial investigates whether a cervicothoracic sympathetic block improves autonomic symptoms in adults with post-COVID condition. Participants receive 5 mL of 0.25% bupivacaine with epinephrine or saline placebo at the injection site, with randomization and standard safety monitoring. Eligibility focuses on adults with PCC lasting at least three months and measurable autonomic symptoms, who are stable on PCC-related medications. The trial is conducted at two Toronto sites under the University Health Network. Outcomes are expected to inform whether this targeted nerve block can relieve dysautonomia-related PCC symptoms and guide future therapy development.

Why it matters

Who can join: the full rules

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

Where it's running

• Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting
• Women's College Hospital
  Toronto, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Anuj Bhatia, MD, PhD — University Health Network, Toronto
• Study coordinator: Emad Al Azazi, MD, PhD
• Email: emad.al-azazi@uhn.ca
• Phone: 4166035800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.