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

Not Applicable
Recruiting
Conditions
Fatigue
Post-Acute COVID-19 Syndrome
Interventions
Procedure: Immunoadsorption vs. sham immunoadsorption
Registration Number
NCT05954325
Lead Sponsor
Hannover Medical School
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham immunoadsorptionImmunoadsorption vs. sham immunoadsorption5 sham immunoadsorption treatments
ImmunoadsorptionImmunoadsorption vs. sham immunoadsorption5 immunoadsorption treatments
Primary Outcome Measures
NameTimeMethod
Chalder Fatigue Scale12 weeks

Time course of fatigue symptoms as determined based on Chalder Fatigue Scale (ranging from 0 to 33), higher values indicating a higher burden of fatigue symptoms

Secondary Outcome Measures
NameTimeMethod
Cognitive Function12 weeks

Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment

Measure of health status12 weeks

Evaluation of health status by Short Form Health Survey (SF-36)

Hand grip strength12 weeks

Hand grip strength measured via digital hand dynamometer

Optical coherence tomography angiography12 weeks

Assessment of retinal microcirculation

Post exertional malaise symptoms12 weeks

Assessment of frequency and severity of post exertional malaise symptoms (frequency: 0-20, severity: 0-20, duration), higher values indicating a higher burden of post exertional malaise symptoms

Cranial magnetic resonance imaging and spectroscopy12 weeks

Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions

Symptoms related to chronic fatigue before and after immunoadsorption12 weeks

Change of symptoms as measured by Fluge score, using a scale ranging from 1 to 10 (higher values representing higher symptom load) assessing 32 fatigue related symptoms and their intra-patient change from baseline to follow-up

Depression and Anxiety12 weeks

Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)

Autonomic dysfunction12 weeks

Symptoms of autonomic dysfunction assessed by Composite Autonomic Symptom Score (COMPASS 31), generating a weighted score from 0 to 100, with higher scores representing higher symptom burden

6-min. walk test12 weeks

Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test

Neurocognitive function12 weeks

Attentional deficits as assessed by Test of Attentional Performance

Trial Locations

Locations (1)

Hannover Medical School

🇩🇪

Hannover, Lower Saxony, Germany

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