Active not recruitingOBSERVATIONAL

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

This study aims to understand why some people have long-lasting symptoms from conditions like Long COVID, ME/CFS (also known as Chronic Fatigue Syndrome), and Persistent Post-Treatment Lyme Disease Syndrome (PTLDS). Researchers are focusing on a part of the immune system called T-cells. They want to see if there are problems with how these T-cells work in affected individuals, which could help explain their symptoms. Up to 160 adults will take part, sharing information about their health and providing a blood sample at the start and after six months. This will help doctors learn more about these conditions and hopefully lead to better ways of diagnosing and treating them in the future.

At a glance

Status

Active not recruiting

Sponsor

ViraxBio Labs

Enrolment target

160

Start

10 Dec 2024

Estimated completion

01 Jun 2026

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

What is this study about?

You might be reading this because you or someone you know is struggling with ongoing symptoms from conditions like Long COVID, ME/CFS, or Persistent Post-Treatment Lyme Disease Syndrome (PTLDS). These conditions can be very challenging to live with, and doctors are still trying to fully understand why they happen and how best to treat them.

This study is a research project designed to help fill some of these gaps in our understanding. Researchers are particularly interested in a specific part of your immune system called T-cells. T-cells are like tiny soldiers that help your body fight off infections and diseases. The study wants to find out if there are any differences or problems with how these T-cells work in people who have Long COVID, ME/CFS, or PTLDS, compared to healthy people.

By carefully looking at T-cells and comparing them between people with these conditions and those who are healthy, the researchers hope to gain new insights. This information could be really important. It might help doctors develop better ways to test for these conditions, understand what causes them, and eventually create more effective treatments. It's an important step towards improving the lives of people affected by these health challenges.

Key takeaways

This study explores why people have ongoing symptoms from Long COVID, ME/CFS, and PTLDS.
It focuses on how T-cells, part of your immune system, might be involved.
Participation involves two visits over six months for questionnaires and blood samples.
The research aims to improve understanding, diagnosis, and treatment for these conditions.
You must be 18 or older with persistent symptoms for at least six months (for Long COVID).

Who may be eligible?

To join this study, you need to be at least 18 years old. If you have Long COVID, you must have had a confirmed COVID-19 infection and still be experiencing symptoms like tiredness, breathlessness, joint pain, or problems with memory and concentration for at least six months after your infection. People with ME/CFS or PTLDS also need to have ongoing symptoms.

There are some reasons why you might not be able to join. For example, if you are currently taking certain medications that affect your immune system, such as steroids or chemotherapy, you won't be able to participate. Also, if you have other serious illnesses that could complicate the study results, or if your doctor thinks it wouldn't be safe or suitable for you, you might not be able to take part. It's important to discuss all your health conditions and medications with the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have ongoing symptoms of Long COVID (with a past COVID infection), ME/CFS, or PTLDS?
If you have Long COVID, have your symptoms (like tiredness, breathlessness, memory problems) lasted for at least 6 months?
Are you able to attend two study appointments (or have a home visit for blood tests) over six months?
Are you willing to temporarily stop certain anti-inflammatory medications (if you take them) for 48 hours before your first visit?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have two main appointments. The first will be when you join the study, and the second will be six months later. At each visit, you'll be asked to fill out a questionnaire about your current symptoms and health. You will also have a blood sample taken. If it's difficult for you to travel due to your illness, the study team might be able to arrange for a blood sample to be taken at your home instead. Before joining, if you take certain anti-inflammatory medications like ibuprofen, you'll need to stop them at least 48 hours beforehand. The study will last for six months from your first visit.

Potential risks and benefits

Taking part in this study may not directly benefit your health immediately, but the information collected could help doctors understand your condition better in the future and lead to improved treatments for others. The main risks involve giving blood samples, which might cause some minor discomfort or bruising. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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

Common questions

What exactly are T-cells?

T-cells are a type of white blood cell that are a key part of your immune system, helping your body fight off infections and diseases.

Do I need to stop all my medications to join?

No, you don't need to stop all medications. However, if you are taking certain anti-inflammatory drugs like ibuprofen, you'll need to pause them for at least 48 hours before your first visit. The study team will review all your medications with you.

What is ME/CFS?

ME/CFS stands for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. It's a complex, long-term illness that affects many body systems, often causing severe fatigue, pain, and other symptoms that worsen after activity.

What is PTLDS?

PTLDS stands for Persistent Post-Treatment Lyme Disease Syndrome. It's a condition where people experience ongoing symptoms like pain, fatigue, and difficulty thinking even after being treated for Lyme disease.

Will I get my test results from the study?

The study aims to collect information to help understand these conditions generally. You might not receive individual results, but the study team can provide more information on their policy for sharing findings.