Long COVID Cutaneous Signatures: An ARPA Funded Research Project (LCCS)

CND Life Sciences

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07005947

The LCCS Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 4 patient groups

Long COVID

Description:

Participants with Long COVID

Acute COVID

Description:

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

Postural Orthostatic Tachycardia Syndrome (POTS)

Description:

Participants with postural orthostatic tachycardia syndrome (POTS)

Diabetic neuropathy

Description:

Participants with diabetic neuropathy