Evaluating T-Cell Dysfunction in Long COVID, Lyme Disease, and Chronic Fatigue Syndrome
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 study is trying to see if problems with T-cells are linked to symptoms in people with long COVID, Lyme disease, and chronic fatigue syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | ViraxBio Labs Research network |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Scotland and 2 other locations) |
| Trial ID | NCT06731179 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the role of T-cell dysfunction in individuals experiencing symptoms related to long COVID, post-treatment Lyme disease syndrome (PTLDS), and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Up to 160 participants will be recruited from three clinical sites, where they will complete questionnaires and provide blood samples at two study visits. Participants will be categorized into groups based on their diagnosis, including a healthy control group, to facilitate comparative analysis of immune responses. The study will help elucidate the underlying immune mechanisms associated with these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with persistent symptoms of long COVID, PTLDS, or ME/CFS for more than six months following an acute COVID-19 infection.
Not a fit: Patients currently on immunosuppressive medications or with significant acute illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and potential treatments for patients suffering from long COVID, Lyme disease, and ME/CFS.
How similar studies have performed: While the specific approach of evaluating T-cell dysfunction in this context may be novel, similar studies have explored immune responses in these conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scotland and 2 other locations
- Curaidh Clinic, Dundee — Scotland, United Kingdom (Recruiting)
- Glasgow and Clyde NHS — Scotland, United Kingdom (Recruiting)
- Monklands University Hospital, NHS — Scotland, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Nigel McCracken
- Email: nm@viraxbiolabs.com
- Phone: +447388863718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.