RECRUITING

Long COVID Immune Profiling

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Parasympathetic nervous system (PNS) is part of the body's autonomic nervous system(PNS) protects body against inflammation. Study shows that reduced PNS function activity is associated with persistent inflammation. Preliminary data from the studies shows, that post-COVID-19 POTS patients have reduced parasympathetic (PNS) function. Given that the PNS protects against inflammation, this clinical trial aims to prove that post-COVID-19 POTS is caused by reduced PNS activity, which in turn, contributes to persistent inflammation, orthostatic intolerance, and OI symptoms. The study will evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity.

Official Title

Long COVID Immune Profiling

Quick Facts

Study Start:2024-04-24
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06027255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects will be 18 years or older, men and women.
  2. * History of confirmed COVID-19 infection (positive contact and symptoms, antigen test or PCR).
  3. * POTS will be defined as the presence of orthostatic tachycardia (\>30 bpm) and chronic (\>3 months) pre-syncopal symptoms.
  4. * Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (\>30 bpm) and chronic (\>3 months) pre-syncopal symptoms. Symptoms occurred within 2 months after COVID infection and persistent until enrollment in the study.
  1. * Individuals with a history of physician diagnosed myocardial infarction, angina, heart failure, stroke, or transient ischemic attack, or who had undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries).
  2. * Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
  3. * Chronic use of steroids, anti-IL6 (omalizumab), anti-TNF-alpha, other immunosuppressants.
  4. * Chronic use of NSAID. Should not enroll if taking without one week prior to blood sampling.
  5. * Treatment with plasmapheresis, IVIG or other immune modulator

Contacts and Locations

Study Contact

Marwa Mohamed, Phd
CONTACT
6159702384
marwa.mohamed@vumc.org
Cyndya Shibao, MD
CONTACT
615-322-3447
cyndya.shibao@vumc.org

Study Locations (Sites)

Cyndya Shibao
Nashville, Tennessee, 37027
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2024-04-24
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • SARS-CoV-2 infection
  • POTS
  • Orthostatic Intolerance
  • Long COVID
  • Long hauler COVID infection

Additional Relevant MeSH Terms

  • Long COVID
  • POTS - Postural Orthostatic Tachycardia Syndrome
  • Autonomic Dysfunction