A Prospective Study to Evaluate the Role of T-Cell Dysfunction in Patients Who Present Symptoms Associated With Long COVID, Lyme Disease and Myalic Encephalomyelitis / Chronic Fatigue Syndrome Using the Vira Immune Fluorospot T Cell Assay

Last updated: April 14, 2025
Sponsor: ViraxBio Labs
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lyme Disease

Pain (Pediatric)

Muscle Pain

Treatment

N/A

Clinical Study ID

NCT06731179
VRX - 002
  • Ages > 15
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a longitudinal observational study recruiting individuals that have attended three clinical sites with symptoms associated with a diagnosis of long COVID, PTLDS or ME/CFS. The study will be a multi-centre study, with up to 160 male and female participants enrolled. Participants that experience symptoms considered to be associated with a diagnosis of long COVID, PTLDS or ME/CFS will consent to the study, and attend for two study visits (at study entry and 6 months) to complete a questionnaire related to their symptoms, and to have a blood sample taken. Blood samples will be taken either at the clinical site or at the participant's home if they are unable to attend due to the severity of their illness. . Participants will be allocated to one of the following groups:

Group 1: Long COVID Group 2: ME/CFS Group 3: PTLDS Group 4: Healthy Control

Eligibility Criteria

Inclusion

Persistent symptoms for groups 1-3 for consistency.

Inclusion Criteria:

  1. Aged 18 years or older

  2. History of acute COVID-19 infection (medically recorded)

  3. Symptoms of fatigue and, shortness of breath and/or, joint pain and/or, problemswith memory and concentration which have been present for more than a period of 6months post infection

  4. Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac, aspirin,etc.) must have been stopped at least 48 hours prior to admission to the clinicalresearch centre (evaluation through questionnaire).

  5. Willing and able to sign the ICF and comply with study procedures.

Exclusion

Exclusion Criteria:

  1. Taking immunosuppressive medication (including corticosteroids), or receivingchemotherapy, cytokine or anti-cytokine therapy, or antithrombotic medication (evaluation through questionnaire).

  2. Significant and/or acute illness within 5 days prior to admission that may impactsafety assessments, in the opinion of the Investigator.

  3. Participants who are, in the opinion of the Investigator, not suitable for enrolmentfor another reason. For example, participants with: cognitive impairment or severemental health conditions that might affect their ability to provide informed consentor follow study procedures; non-adherence risk where participants are unlikely tofollow study protocols; participants with other chronic inflammatory conditions notunder investigation e.g. inflammatory bowel disease, COPD that may have immuneprofiles that differ from the study's intended populationI

Study Design

Total Participants: 160
Study Start date:
December 10, 2024
Estimated Completion Date:
June 01, 2026

Connect with a study center

  • Curaidh Clinic, Dundee

    Scotland,
    United Kingdom

    Active - Recruiting

  • Glasgow and Clyde NHS

    Scotland,
    United Kingdom

    Active - Recruiting

  • Monklands University Hospital, NHS

    Scotland,
    United Kingdom

    Active - Recruiting

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