NCT06731179Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 11 Dec 2024
- Start date
- 10 Dec 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- ViraxBio Labs
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06731179
What you commit to
- Study type: Observational
- Planned participants: 160
- From 10 Dec 2024 to the primary completion date, 1 Jun 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Who the study is looking for
- 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.
Criteria the registry did not label
- Persistent symptoms for groups 1-3 for consistency.
Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monklands University Hospital, NHS Coordinator of this site? Confirm its status | Airdrie | United Kingdom | Unknown status |
| Glasgow and Clyde NHS Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Raigmore Hospital, Inverness Coordinator of this site? Confirm its status | Inverness | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.