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

STUDY TO EVALUATE THE ROLE OF T CELL-DYSFUNCTION IN SYMPTOMS ASSOCIATED WITH LONG COVID, LYME DISEASE AND MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME USING THE VIRAXIMMUNE FLUOROSPOT T CELL ASSAY

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

Study Overview

• Status: Active, not recruiting
• Conditions: Long COVID; PTLDs; Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• United Kingdom
  • Airdrie, United Kingdom
    • Monklands University Hospital, NHS
  • Glasgow, United Kingdom
    • Glasgow and Clyde NHS
  • Inverness, United Kingdom
    • Raigmore Hospital, Inverness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Up to 120 male and female participants identified as having persistent symptoms associated with a diagnosis of long COVID, PTLDS or ME/CFS. Additionally, up to 40 healthy male and female who have not been clinically diagnosed as having symptoms associated with long COVID, PTLDS or ME/CFS will be enrolled as a control group.

Description

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, problems with memory and concentration which have been present for more than a period of 6 months 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 clinical research centre (evaluation through questionnaire).
5. Willing and able to sign the ICF and comply with study procedures.

Exclusion Criteria:

1. Taking immunosuppressive medication (including corticosteroids), or receiving chemotherapy, 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 impact safety assessments, in the opinion of the Investigator.
3. Participants who are, in the opinion of the Investigator, not suitable for enrolment for another reason. For example, participants with: cognitive impairment or severe mental health conditions that might affect their ability to provide informed consent or follow study procedures; non-adherence risk where participants are unlikely to follow study protocols; participants with other chronic inflammatory conditions not under investigation e.g. inflammatory bowel disease, COPD that may have immune profiles that differ from the study's intended populationI

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Long COVID diagnosis
ME/CFS symptoms
PTLDS symptoms
Healthy Individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the ViraxImmune FluoroSpot T cell assay (PPA / NPA - predicted outcome)	To evaluate the performance of the ViraxImmune FluoroSpot T cell assay to identify T cell dysfunction in participants diagnosed with long COVID, post treatment Lyme disease (PTLD) and Myalgic Encephalomyelitis/Chronic Fatigue (ME/CFS)	18 months

Collaborators and Investigators

• Sponsor: ViraxBio Labs

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Post-Infectious Disorders; COVID-19; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic
• Other Study ID Numbers: VRX - 002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No