Comparing immunoadsorption and sham treatment for chronic fatigue after COVID-19
Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
This study is testing if a blood treatment called immunoadsorption can help people who are feeling very tired after recovering from COVID-19 feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 1 site (Hannover, Lower Saxony) |
| Trial ID | NCT05954325 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of immunoadsorption, a procedure that removes autoantibodies from the blood, in treating chronic fatigue syndrome (CFS) in patients who have recovered from COVID-19. It is a randomized, sham-controlled trial designed to provide scientific evidence on the therapeutic efficacy of this treatment. Participants will undergo either the immunoadsorption procedure or a sham treatment, with their symptoms assessed over time to determine any improvements in fatigue levels. The study also aims to enhance understanding of the underlying mechanisms of post COVID syndrome.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have been diagnosed with chronic fatigue syndrome following a confirmed COVID-19 infection.
Not a fit: Patients with chronic fatigue syndrome not related to COVID-19 or those with other underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate chronic fatigue symptoms in post COVID-19 patients, improving their quality of life.
How similar studies have performed: While there have been uncontrolled case studies suggesting benefits of autoantibody removal in similar patients, this study represents a novel approach with a controlled methodology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hannover, Lower Saxony
- Hannover Medical School — Hannover, Lower Saxony, Germany (Recruiting)
Study contacts
- Principal investigator: Dr. Goedecke, MD — Hannover Medical School, Department of Nephrology and Hypertension
- Study coordinator: Dr. Goedecke, MD
- Email: studienzentrum@mh-hannover.de
- Phone: 0049-511-532-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.