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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monklands University Hospital, NHS
Coordinator of this site? Confirm its status
AirdrieUnited KingdomUnknown status
Glasgow and Clyde NHS
Coordinator of this site? Confirm its status
GlasgowUnited KingdomUnknown status
Raigmore Hospital, Inverness
Coordinator of this site? Confirm its status
InvernessUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.