The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose amajor challenge to patients and to the health care system and are frequently refractoryto therapeutic intervention. There is increasing evidence that a dysregulated post-viralimmune response may be involved in the pathogenesis of post COVID syndrome. Inuncontrolled case studies, an improvement of fatigue symptoms after removingautoantibodies has been reported in post COVID patients. However, there is a lack ofprospective, sham controlled studies. We initiate an interventional, randomised, shamtreatment-controlled prospective study, the EXTINCT post COVID study, which aims toscientifically test the therapeutic efficacy of an extracorporeal apheresis procedure(immunoadsorption) for the treatment of a well characterized cohort of patients with postCOVID syndrome, while at the same time providing basic research evidence for anunderstanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtainimportant insights into the diagnosis, treatment and pathophysiology of post-COVIDsyndrome.
Not Provided
Procedure: Immunoadsorption vs. sham immunoadsorption
5 treatments within 14 days
Other Name: Apheresis
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
Hannover Medical School
Hannover, Lower Saxony, Germany
Investigator: Hannover Medical School
Contact: 0049-511-532-0
studienzentrum@mh-hannover.de
Dr. Goedecke, MD
0049-511-532-0 - 3000
studienzentrum@mh-hannover.de
Prof. Schmidt, MD
0049-511-532-0 - 3000
studienzentrum@mh-hannover.de
Dr. Goedecke, MD, Principal Investigator
Hannover Medical School, Department of Nephrology and Hypertension