Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS (clinical trial started in 2023)

[kushami]

Clinical trial in Germany:

The goal of this clinical trial is to learn about the effectiveness of repeated immunoadsorption intervention in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS).

The main questions it aims to answer are: (1) Does repeated immunoadsorption relieve fatigue and/or other symptoms associated with CFS and PACS-CFS? (2) Is repeated immunoadsorption safe and tolerable in this patient population? What are the side effects of repeated immunoadsorption, and how common are they?

Participants will be asked to participate for approx. 32 weeks (8 months). After screening, participants will receive assigned intervention of either five immunoadsorption treatments (with Ig adsorber) every other day over 10 days or matching sham treatments (without Ig adsorber), followed by a 6-month follow-up period with three ambulatory visits. Every participant will undergo trial outcome, safety, and monitoring assessments.

The results of this study will provide information on whether repeated immunoadsorption can alleviate symptoms associated with CFS and PACS-CFS, as well as insights into the pathophysiological processes in this condition, which in turn can help to develop new and effective therapies.

Estimated completion date: 2025

https://clinicaltrials.gov/study/NCT05710770

https://pubmed.ncbi.nlm.nih.gov/37835071/

 

[Bobby Peru]

FWIW, Here is a rundown of immunoadsorption, albeit from a study directed towards organ transplants.

Immunoadsorption, also known as immunoapheresis, is an adsorptive procedure in an extracorporeal circuit to remove circulating antibodies and antibody complexes from the blood of patients with different immune disorders or rejection reactions [1].

Autoimmune diseases are conditions in which immune responses are directed toward endogenous cells, tissues, and antigens. Formation of antibodies against the body's own tissue may affect nearly all organ systems.

In organ transplantation, the immune system recognizes the transplanted organ as foreign tissue, and the resulting inflammation associated with a rejection reaction can lead to the loss of the transplanted organ.

Immunoadsorption, in contrast to nonspecific plasma exchange, offers the advantage of specificity, that is, only antibodies and immune complexes are removed and other important plasma constituents, for example, albumin and coagulation factors remain with the patient. An accompanying substitution with plasma or colloidal solutions is thus not required. This allows larger plasma volumes to be treated than with plasma exchange, enhancing reduction rates of IgG antibodies or autoantibodies and immune complexes [2], with a low rate of side effects [3].

Immunoadsorption is considered as a therapeutic option in a wide variety of autoimmune diseases and for desensitization before organ transplantation or at acute antibody mediated rejection [4, 5, 6, 7]. It is indicated in all diseases in which circulating, disease‐causing immune factors have been identified to be involved in the onset and progression of the disease. Usually, the procedure is applied in patients in whom other conventional therapies, such as pharmacological therapies, are not successful [7].
Reported IgG reduction was significant in this study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9291474/

 

[kushami]

That’s interesting that immunoadsorption can treat a larger volume in one session.

 

[kushami]

I wonder whether the treatment, if successful, will “stick”. Feeling better would be wonderful, but having to have frequent hospital sessions would not be ideal for the patient or the health system.

Still, that’s what people on dialysis have to do, so there is knowledge out there on how to manage this type of treatment burden.

And perhaps patients would only need to repeat the ten days of intensive treatment once a year or something.

Anyway, I really hope it ends up helping somehow!

 

[cfs since 1998]

I wonder whether the treatment, if successful, will “stick”. Feeling better would be wonderful, but having to have frequent hospital sessions would not be ideal for the patient or the health system.

Probably not unless they can stop the process creating the autoantibodies. In the future, they want to do a trial of IA combined with obinutuzumab (similar to rituximab). I wonder if the "inverse vaccine" concept being worked on for MS could be used as well. I also think there is probably more than one kind of autoantibody, so they will have to find all of them.