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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
5 treatments within 14 days
Hannover Medical School
Hanover, Lower Saxony, Germany
Chalder Fatigue Scale
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
Time frame: 12 weeks
Cognitive Function
Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment
Time frame: 12 weeks
Post exertional malaise symptoms
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
Time frame: 12 weeks
Measure of health status
Evaluation of health status by Short Form Health Survey (SF-36)
Time frame: 12 weeks
Depression and Anxiety
Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Autonomic dysfunction
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
Time frame: 12 weeks
6-min. walk test
Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test
Time frame: 12 weeks
Hand grip strength
Hand grip strength measured via digital hand dynamometer
Time frame: 12 weeks
Optical coherence tomography angiography
Assessment of retinal microcirculation
Time frame: 12 weeks
Cranial magnetic resonance imaging and spectroscopy
Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions
Time frame: 12 weeks
Symptoms related to chronic fatigue before and after immunoadsorption
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
Time frame: 12 weeks
Neurocognitive function
Attentional deficits as assessed by Test of Attentional Performance
Time frame: 12 weeks
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