Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS (IA-PACS-CFS)

Project description

The etiology and the mechanisms leading to the typical chronic course of ME/CFS or the pathophysiology of post-acute COVID-19 syndrome (PACS) are not fully understood. There is increasing evidence that a post-viral autoimmune reaction with the presence of autoantibodies targeting different neuronal tissues is involved in the pathogeneses.

This is a double-blinded, randomized, sham-controlled immunoadsorption (IA) study in patients with chronic fatigue syndrome (CFS) including patients with CFS related to post-acute COVID-19 syndrome (PACS-CFS), as part of the of the clinical trials within the National Clinical Study Group (NKSG). Primary endpoint of the study is clinical improvement 3 months after the completion of immunoadsorption (IA) quantified using the change from baseline of the Chalder Fatigue Scale (range 0-33). Patients are randomized 2:1 in order to provide therapy to as many patients as possible. During the screening period, all patients are tested for the presence of autoantibodies in blood and cerebrospinal fluid (CSF). A comprehensive characterization by CFS specific questionnaires, quality of life questionnaires (PROMIS), cognitive and neuropsychological testing (MOCA, CANTAB) is performed, and each patient is offered to receive an optional cranial MRI before and after immunoadsorption. Depending on the clinical phenotype, electromyography and pulmonary function testing will be done. The investigators will use established hand strength and finger tapping devices as well as an accelerometer to objectify clinical improvement. Patients are hospitalised for 9-12 days receiving IA 5 times every other day. Follow-up visit will be held directly after completion of IA as well as at month 1, 3 and 6.

The aim of the trial is to better understand disease mechanisms and thereby allow for (potentially biomarker associated) characterisation of patients benefitting from such a costly but safe and often highly efficient treatment intervention.

(Description adapted from clinical trial website: see link above)