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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunoadsorption | Experimental | 5 immunoadsorption treatments |
|
| Sham immunoadsorption | Sham Comparator | 5 sham immunoadsorption treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoadsorption vs. sham immunoadsorption | Procedure | 5 treatments within 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function | Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment | 12 weeks |
| Post exertional malaise symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of immunoadsorption treatment | Number of treatment emergent adverse events, serious adverse events and discontinuation due to treatment emergent adverse events | 12 weeks |
Inclusion Criteria:
Exclusion citeria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Goedecke, MD | Hannover Medical School, Department of Nephrology and Hypertension | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | Lower Saxony | 30625 | Germany |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Double-blinded, randomized, sham-controlled trial
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double-blind
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
| 12 weeks |
| Measure of health status | Evaluation of health status by Short Form Health Survey (SF-36) | 12 weeks |
| Depression and Anxiety | Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS) | 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 | 12 weeks |
| 6-min. walk test | Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test | 12 weeks |
| Hand grip strength | Hand grip strength measured via digital hand dynamometer | 12 weeks |
| Optical coherence tomography angiography | Assessment of retinal microcirculation | 12 weeks |
| Cranial magnetic resonance imaging and spectroscopy | Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions | 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 | 12 weeks |
| Neurocognitive function | Attentional deficits as assessed by Test of Attentional Performance | 12 weeks |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |