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

NCT06731179 | Active Not Recruiting

• 1 other identifier: VRX - 002
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Long COVID; PTLDs; Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Long COVID diagnosis

Long COVID diagnosis

ME/CFS symptoms

ME/CFS symptoms

PTLDS symptoms

PTLDS symptoms

Healthy Individuals

Healthy Individuals

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years or older
• History of acute COVID-19 infection (medically recorded)
• 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
• 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).
• Willing and able to sign the ICF and comply with study procedures.

You may not qualify if:

• Taking immunosuppressive medication (including corticosteroids), or receiving chemotherapy, cytokine or anti-cytokine therapy, or antithrombotic medication (evaluation through questionnaire).
• Significant and/or acute illness within 5 days prior to admission that may impact safety assessments, in the opinion of the Investigator.
• 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

Sponsors & Collaborators

• ViraxBio Labs: lead

Study Sites (3)

Monklands University Hospital, NHS

Airdrie, United Kingdom

Location

Glasgow and Clyde NHS

Glasgow, United Kingdom

Location

Raigmore Hospital, Inverness

Inverness, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual blood specimens - frozen

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic

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; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 12, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)