Long COVID Cutaneous Signatures: An ARPA Funded Research Project

Recruiting

• Conditions: Long COVID; Acute COVID-19; Postural Orthostatic Tachycardia Syndrome (POTS); Diabetic Neuropathy

• Registration Number: NCT07005947
• Lead Sponsor: CND Life Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes	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.

Trial Locations

Locations (1)

CND Life Sciences; 🇺🇸 Scottsdale, Arizona, United States