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

NCT07005947 | Active Not Recruiting

• 1 other identifier: The LCCS Study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID; Diabetic Neuropathy; Postural orthostatic tachycardia syndrome; POTS

Outcome Measures

Primary Outcomes (1)

• Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes

  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.

  Current - December 31,2025

Study Arms (4)

Long COVID

Participants with Long COVID

Acute COVID

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

Postural Orthostatic Tachycardia Syndrome (POTS)

Participants with postural orthostatic tachycardia syndrome (POTS)

Diabetic neuropathy

Participants with diabetic neuropathy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and females ages 18-80 who have been diagnosed with one of the following: 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CND Life Sciences: lead

Study Sites (1)

CND Life Sciences

Scottsdale, Arizona, 85258, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Three skin biopsies and one plasma blood collection.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Postural Orthostatic Tachycardia Syndrome; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 5, 2025
• Study Start: November 30, 2023
• Primary Completion: February 28, 2026
• Study Completion: April 16, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)