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OpenTrials
Completed

NCT Number: NCT07005947

Long COVID-19 Cutaneous Signatures: An ARPA Funded Research Project

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.

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Key information

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CND Life Sciences

Other

Registry information

Acronym: LCCS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.