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

Fatigue Clinical Trial

Official title:

Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954325
• Other study ID #: EXTINCT post COVID
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Hannover Medical School
• Contact: Dr. Goedecke, MD
• Phone: 0049-511-532-0
• Email: studienzentrum[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Fatigue
• Syndrome

Intervention

Procedure:
• Immunoadsorption vs. sham immunoadsorption
5 treatments within 14 days

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	Cognitive Function	Assessment of cognitive function measured by Montreal Cognitive Assessment (Scale 0-30), lower values indicating cognitive impairment	12 weeks
Secondary	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	12 weeks
Secondary	Measure of health status	Evaluation of health status by Short Form Health Survey (SF-36)	12 weeks
Secondary	Depression and Anxiety	Symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)	12 weeks
Secondary	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
Secondary	6-min. walk test	Walking distance, oxygen saturation, heart rate and dyspnea assessed during 6-min. walk test	12 weeks
Secondary	Hand grip strength	Hand grip strength measured via digital hand dynamometer	12 weeks
Secondary	Optical coherence tomography angiography	Assessment of retinal microcirculation	12 weeks
Secondary	Cranial magnetic resonance imaging and spectroscopy	Cranial magnetic resonance imaging and assessment of region-dependent metabolic distributions	12 weeks
Secondary	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
Secondary	Neurocognitive function	Attentional deficits as assessed by Test of Attentional Performance	12 weeks