Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into a treatment called immunoadsorption for people with chronic fatigue syndrome (CFS), including those who have developed CFS after having COVID-19. The main goal is to see if this treatment can help reduce fatigue and other symptoms associated with CFS, and to ensure that it is safe for patients to use. Participants in the trial will receive either the treatment or a similar placebo (which looks like the treatment but doesn’t have the active ingredient) over a period of about 10 days, followed by a 6-month follow-up to monitor their health.

To join the study, participants need to be adults aged 18 to 65 who have been diagnosed with CFS. They should have a specific level of fatigue and must show signs of certain autoantibodies in their blood or spinal fluid. However, some individuals may not be eligible due to serious health issues, ongoing treatments that could interfere with the study, or other conditions that might explain their symptoms better than CFS. Throughout the study, participants will have regular check-ins to assess their health and any side effects. This research aims to better understand CFS and potentially lead to new treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects of all genders ≥18 \<65 years at time of informed consent
• • Diagnosed ME/CFS according to Canadian consensus criteria (CCC) 2003 including patients with PACS-CFS at screening with Bell Score ≥20 and ≤50
• • Detection of at least one kind of autoantibodies measured during screening (among others antineuronal-, ß2-adrenergic-receptor-, muscarine-receptorantibodies) in serum or CSF
• Exclusion Criteria:
• * Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others:
• • malignant disease within the last 5 years
• • clinically meaningful laboratory abnormalities
• • moderate to severe renal insufficiency
• • cardiac insufficiency with an LVEF lower than 40%, uncontrolled cardiac arrhythmia, severe coronary heart disease
• • severe Hypercoagulability
• • Acute or severe psychiatric disease
• • Current indispensable medication with ACE inhibitors
• • Fatigue duration for ≥5 years
• • Presence of other conditions or differential diagnosis better explaining the symptoms of the patient than the suspected ME/CFS
• • Ongoing immunosuppressive therapy
• • Active/acute infectious diseases like TBC, HIV, CMV, EBV, HBV, HBC