Immunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome

Inclusion Criteria

• •1. Age 18-75 years
• •2. Chronic Fatigue Syndrome (CFS) according to Canadian Consensus Criteria (at two time points \> 4 weeks apart) with a duration of \> 6 months with new onset \< 12 weeks after PCR test confirmed SARS-CoV2-infection
• •3. Chalder Fatigue Scale \>/= 4 binary scale (at two time points \> 4 weeks apart)
• •4. Post exertional malaise \>/= 14 h (at two time points \> 4 weeks apart)
• •5. Bell Scale 20-50 (at two time points \> 4 weeks apart)
• •6. Willing to comply with all aspects of the protocol, including blood draws, magnetic resonance imaging and ophthalmological evaluation
• •7. Patient is able to understand and fully participate in the activities of the study and consent in accordance with guidelines
• •8. Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire period.
• •Exclusion citeria:
• •1. Chronic fatigue due to other medical or psychological condition
• •2. Preexisting chronic fatigue prior to COVID infection
• •3. Oxygen requirement or ventilation during acute phase of COVID
• •4. Positive SARS-CoV-2-PCR test at the beginning of the study
• •5. Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others: malignant disease within the last 5 years, moderate to severe renal impairment (eGFR \<60 ml/min), cardiac insufficiency (LVEF \<40%), severe coronary heart disease, severe hypercoagulability
• •6. Acute or severe psychiatric disease
• •7. Active/acute infectious diseases like CMV, EBV, HBV, HCV, HIV, TBC
• •8. Patients who in the investigator's opinion might not be suitable for study (difficult peripheral venous access, not able to complete questionnaires e.g. due to language problems)
• •9. Taking immunosuppressive medication \>3 weeks within 12 months before study inclusion
• •10. Any apheresis therapy before study inclusion
• •11. Contraindications for magnetic resonance imaging
• •12. Patients revealing abnormal brain structures visible in MR images
• •13. Patients with pre-existing ophthalmological condition or diabetes mellitus