Clinical trial NCT05954325: Immunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome
Official title: Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatigue
Post-Acute COVID-19 Syndrome
Keywords: Post COVID syndrome
Fatigue
Immunoadsorption
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized, sham-controlled trial
Primary purpose: TREATMENT

Brief summary: The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose a major challenge to patients and to the health care system and are frequently refractory to therapeutic intervention. There is increasing evidence that a dysregulated post-viral immune response may be involved in the pathogenesis of post COVID syndrome. In uncontrolled case studies, an improvement of fatigue symptoms after removing autoantibodies has been reported in post COVID patients. However, there is a lack of prospective, sham controlled studies. We initiate an interventional, randomised, sham treatment-controlled prospective study, the EXTINCT post COVID study, which aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome.


Eligibility criteria: 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

Primary outcomes:
measure: Chalder Fatigue Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Cognitive Function
timeFrame: 12 weeks
measure: Post exertional malaise symptoms
timeFrame: 12 weeks
measure: Measure of health status
timeFrame: 12 weeks
measure: Depression and Anxiety
timeFrame: 12 weeks
measure: Autonomic dysfunction
timeFrame: 12 weeks
measure: 6-min. walk test
timeFrame: 12 weeks
measure: Hand grip strength
timeFrame: 12 weeks
measure: Optical coherence tomography angiography
timeFrame: 12 weeks
measure: Cranial magnetic resonance imaging and spectroscopy
timeFrame: 12 weeks
measure: Symptoms related to chronic fatigue before and after immunoadsorption
timeFrame: 12 weeks
measure: Neurocognitive function
timeFrame: 12 weeks
Other outcomes:
measure: Safety and tolerability of immunoadsorption treatment
timeFrame: 12 weeks
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School, Department of Nephrology and Hypertension
name: Dr. Goedecke, MD
role: PRINCIPAL_INVESTIGATOR
References: