Protocol: Randomized-controlled Trial of Immunoadsorption (IA) in Patients With CFS Including Patients With Post-COVID-19 CFS, 2023, Burock

Study Description


Brief Summary:
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 CSF and PACS-CSF? (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 CSF and PACS-CSF, as well as insights into the pathophysiological processes in this condition, which in turn can help to develop new and effective therapies.

https://clinicaltrials.gov/ct2/show/NCT05710770?cond=ME/CFS&cntry=DE&draw=2&rank=3

 

*Squints closer*
CSF
Ah yes, the elusive disorder ME/CSF. Confusingly, the study also refers to CSF (cerebrospinal fluid) correctly.

 

Primary outcome is Chalder fatigue scale.
If this is genuinely blinded it may not matter if the outcome measure is suboptimal.

 

They plan to recruit 66 patients of which 44 will be randomized to the Immunoadsorption group if I understand correctly. The other 22 will receive a sham intervention. So the idea is to plan patients but unfortunately it will not be possible to blind the nurses administrating the treatment.

Weird that they choose the Chalder Fatigue scale as the primary outcome but there are more than 10 secondary outcomes includes secondary ones.