Long COVID-19 Cutaneous Signatures: An ARPA Funded Research Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 237
- Locations
- 1
- Primary Endpoint
- Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes
Study Overview
Brief Summary
This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID-19 neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system.
Detailed Description
This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID-19 neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system. The evaluations will include clinical assessments, neurologic exams, patient reported outcome surveys, and skin biopsies from three locations. Data will be collected on the amount of P-SYN in cutaneous nerve fibers. The cohorts of interest are as follows:
- 100 participants with Long COVID-19 defined by NIH PASC criteria
- 100 participants with acute COVID-19 who tested positive for COVID-19 without persistent symptoms defined WHO criteria
- 50 participants with postural orthostatic tachycardia syndrome (POTS)
- 50 participants with diabetic neuropathy
There are no plans for additional visits at this time.
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Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •, just one of the following:
- •Long COVID-19 defined by NIH PASC criteria OR
- •Acute COVID-19 who tested positive for COVID-19 without persistent symptoms OR
- •Postural orthostatic tachycardia syndrome (POTS) OR
- •Diabetic neuropathy
Exclusion Criteria
- •Clinical evidence of severe peripheral vascular disease
- •History of ulceration, poor wound healing or vascular claudication
- •History of allergic reaction to local anesthesia (for biopsy collection)
- •Use of oral anticoagulants (aspirin or Plavix alone is allowed)
- •History of a bleeding disorder
Arms & Interventions
Diabetic neuropathy
Participants with diabetic neuropathy
Postural Orthostatic Tachycardia Syndrome (POTS)
Participants with postural orthostatic tachycardia syndrome (POTS)
Long COVID
Participants with Long COVID
Acute COVID
Participants with acute COVID who tested positive for COVID without persistent symptoms
Outcomes
Primary Outcomes
Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes
Time Frame: Current - December 31,2025
This is a single site study of subjects with Long COVID, subject with a previous positive COVID test without persistent symptoms, and POTS subjects and diabetics. Neurocutaneous biosignatures will provide insight into the pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes.
Secondary Outcomes
No secondary outcomes reported