Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07468604 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition

Study acronym: CeASE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from University Health Network, Toronto

Record History

  1. Minor Secondary endpoints: details revised at 1 of 13 entries
  2. Notable Primary endpoint(s) modified Interventions modified · Study sites: 3 to 2 · Eligibility criteria expanded, about 17 words · 1 more Show 4 more changesShow less
    • Interventions modified
    • Study sites: 3 to 2
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints expanded, about 55 words
  3. Notable Recruitment opened Primary completion pushed from Apr 1, 2027 to May 20, 2027 · Trial sites expanded: 0 → 3 locations · Start date changed from estimate of Apr 1, 2026 to May 19, 2026v2 Show 3 more changesShow less
    • Primary completion pushed from Apr 1, 2027 to May 20, 2027
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Apr 1, 2026 to May 19, 2026
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07468604
Lead Sponsor University Health Network, Toronto
Conditions Autonomic Dysfunction
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov