RecruitingOBSERVATIONAL

Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS

This study is investigating a treatment called Immunoadsorption (IA) for people living with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This includes those whose ME/CFS developed after a COVID-19 infection. ME/CFS can cause extreme tiredness, pain, and other debilitating symptoms, often triggered by an infection, and there isn't yet a cure. IA is a treatment that helps remove certain substances, called autoantibodies, from the blood, which may be contributing to ME/CFS symptoms. Researchers want to observe 50 patients receiving IA as part of their routine care to see if their symptoms improve. They also want to check if specific blood markers before treatment might indicate who will respond best. This information will help guide future research into more effective ME/CFS treatments.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

11 Mar 2026

Estimated completion

31 Dec 2027

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)ME/CFS Following COVID-19

What is this study about?

This study is looking into a treatment called Immunoadsorption (IA) for people experiencing Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). ME/CFS is a complex illness that often follows an infection and causes extreme tiredness, lasting for more than 14 hours after even small efforts. People with ME/CFS also often deal with pain, memory and concentration problems, and sleep difficulties. More recently, some people who have had COVID-19 are finding they develop ME/CFS-like symptoms, which is sometimes called Post-COVID Syndrome (PCS).

Currently, there isn't a specific cure for ME/CFS or PCS. Treatments usually focus on easing symptoms and helping people manage their daily lives. However, there's a real and urgent need to find better, more targeted treatments. This is where Immunoadsorption (IA) comes in. It's a treatment that is already used for some other conditions where the body's immune system might be mistakenly attacking itself. Our research group has previously seen positive results using IA in people with ME/CFS, especially when it's linked to an infection.

The main idea behind this study is to see if reducing certain 'autoantibodies' (which are substances in your blood that might be causing the problem) through IA can improve symptoms for most people with ME/CFS. We also want to understand if we can predict who will respond well to this treatment by looking at changes in certain immune cells in their blood before they start IA. By carefully watching 50 patients who are already receiving IA, we hope to gather valuable information that will support further research into this promising treatment.

Key takeaways

The study investigates Immunoadsorption (IA) for ME/CFS and Post-COVID Syndrome (PCS).
It aims to see if IA improves ME/CFS symptoms, particularly in patients with specific blood markers.
Participation involves receiving IA as part of routine care and sharing health information for research.
Researchers will track symptom changes and blood markers over 12 months.
This is an observational study, meaning it watches existing treatment, not testing a new one.

Who may be eligible?

To be considered for this study, you would need to be between 18 and 65 years old and be able to understand the study and agree to take part. A doctor must have diagnosed you with ME/CFS using specific guidelines (called the Canadian Consensus Criteria). A key part of your ME/CFS must be that you feel much worse after even small physical or mental effort, and this worse feeling lasts for at least 14 hours. Your ME/CFS should also be significantly impacting your daily life.

Another important requirement is that blood tests need to show you have certain 'autoantibodies' (specific immune system markers like adrenergic or antineuronal antibodies) in your system. You also need to be undergoing the Immunoadsorption (IA) treatment using the TheraSorb® column over five days as part of your routine care. Having health insurance and being willing to have your anonymous health information used for the study are also necessary.

There are some reasons why you might not be able to join the study. These include if you are pregnant, or if you have other serious health conditions like heart failure, severe depression, or cancer that might explain your symptoms better than ME/CFS. Acute infections like COVID, HIV, or hepatitis would also prevent participation, as would very severe ME/CFS where you are mostly confined to bed.

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 between 18 and 65 years old?
Have you been diagnosed with ME/CFS by a doctor using specific criteria?
Do you experience significant worsening of symptoms (fatigue, pain, etc.) for over 14 hours after even small efforts?
Do blood tests show you have specific 'autoantibodies' (e.g., adrenergic, antineuronal)?
Are you currently scheduled to receive Immunoadsorption (IA) treatment using the TheraSorb® column over 5 days?
Are you not pregnant and do not have other serious illnesses like heart failure, cancer, or acute infections like HIV?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's important to understand that the Immunoadsorption (IA) treatment itself is something you would be receiving as part of your usual medical care, independent of the study. The standard IA treatment involves five sessions over eight days, typically on days 1, 2, 4, 6, and 8.

As part of the study, before you start IA, you'll have an initial assessment. This includes routine blood tests, some special tests for immune system markers (like immunoglobulins and autoantibodies), and other checks deemed necessary by your doctor. About 50ml of blood will be collected at this first visit. You'll also complete some detailed health questionnaires about your symptoms and how they affect your daily life.

After your IA treatment, you'll receive these questionnaires by post every month for a year to complete at home. This helps track your progress and symptom severity over time. Additionally, at 2 months and again at 6 months after your IA treatment, you will have follow-up assessments. These will involve some physical tests, like measuring your handgrip strength and a test called the NASA Lean Test, and further blood samples. The total time you'll be involved in the study part of your care is 12 months after your IA treatment.

Potential risks and benefits

Taking part in this study may offer some potential benefits by helping researchers better understand how Immunoadsorption (IA) affects ME/CFS symptoms and who might benefit most. This knowledge could lead to better treatments for ME/CFS in the future. However, there are no direct medical benefits to you from participating in the study itself, as the IA treatment is part of your regular care. As with any medical procedure, IA has its own potential risks, which your doctor will discuss with you. Any blood draws or physical tests involved in the study carry minimal risks, similar to routine medical checks. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is ME/CFS?

ME/CFS stands for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. It's a serious, long-term illness causing extreme tiredness that doesn't get better with rest, and other symptoms like pain, sleep problems, and difficulty thinking clearly.

What is Immunoadsorption (IA)?

IA is a treatment that cleans your blood by removing certain substances, called autoantibodies, which are thought to be involved in some medical conditions where the body's immune system mistakenly attacks its own tissues.

Is this study giving me new treatment?

No, the study is observing patients who are already receiving Immunoadsorption (IA) as part of their routine medical care for ME/CFS. The IA itself is not a new treatment being tested in this specific study.

Why are researchers interested in ME/CFS after COVID-19?

Some people who've had COVID-19 develop long-lasting symptoms similar to ME/CFS, called Post-COVID Syndrome. This study includes these patients to see if IA might help them too, as ME/CFS often follows infections.

Will I have to travel a lot for the study?

The IA treatment sessions require you to attend the clinic five times over eight days. After that, most study questionnaires will be mailed to your home. You'll only need to return to the clinic for assessments at 2 and 6 months after your IA treatment.

How to find out more

Elisa A Stein, Dr.

elisa.stein@charite.de +49 450 624354 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.