Long COVID Cutaneous Signatures: An ARPA Funded Research Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-12-31

Brief Summary

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This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system.

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Detailed Description

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This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID 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:

1. 100 participants with Long COVID defined by NIH PASC criteria
2. 100 participants with acute COVID who tested positive for COVID without persistent symptoms defined WHO criteria
3. 50 participants with postural orthostatic tachycardia syndrome (POTS)
4. 50 participants with diabetic neuropathy

There are no plans for additional visits at this time.

If interested to learn more about this study, please complete the form here for someone to contact you. "here" would take you to the said form.

Conditions

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Long COVID Acute COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS) Diabetic Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long COVID

Participants with Long COVID

No interventions assigned to this group

Acute COVID

Participants with acute COVID who tested positive for COVID without persistent symptoms

No interventions assigned to this group

Postural Orthostatic Tachycardia Syndrome (POTS)

Participants with postural orthostatic tachycardia syndrome (POTS)

No interventions assigned to this group

Diabetic neuropathy

Participants with diabetic neuropathy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1\. Long COVID defined by NIH PASC criteria OR 2. Acute COVID who tested positive for COVID without persistent symptoms OR 3. Postural orthostatic tachycardia syndrome (POTS) OR 4. Diabetic neuropathy

Exclusion Criteria

1\. Clinical evidence of severe peripheral vascular disease 2. History of ulceration, poor wound healing or vascular claudication 3. History of allergic reaction to local anesthesia (for biopsy collection) 4. Use of oral anticoagulants (aspirin or Plavix alone is allowed) 5. History of a bleeding disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No