NCT05954325Completed
Immunoadsorption vs. Sham Treatment in Post COVID-19 Patients With Chronic Fatigue Syndrome
Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 19 Jul 2023
- Start date
- 15 Aug 2023
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Hannover Medical School
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05954325
What you commit to
- Study type: Interventional
- Participants enrolled: 63
- From 15 Aug 2023 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Age 18-75 years
- 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
- Chalder Fatigue Scale \>/= 4 binary scale (at two time points \> 4 weeks apart)
- Post exertional malaise \>/= 14 h (at two time points \> 4 weeks apart)
- Bell Scale 20-50 (at two time points \> 4 weeks apart)
- Willing to comply with all aspects of the protocol, including blood draws, magnetic resonance imaging and ophthalmological evaluation
- Patient is able to understand and fully participate in the activities of the study and consent in accordance with guidelines
- 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:
- Chronic fatigue due to other medical or psychological condition
- Preexisting chronic fatigue prior to COVID infection
- Oxygen requirement or ventilation during acute phase of COVID
- Positive SARS-CoV-2-PCR test at the beginning of the study
- 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
- Acute or severe psychiatric disease
- Active/acute infectious diseases like CMV, EBV, HBV, HCV, HIV, TBC
- 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)
- Taking immunosuppressive medication \>3 weeks within 12 months before study inclusion
- Any apheresis therapy before study inclusion
- Contraindications for magnetic resonance imaging
- Patients revealing abnormal brain structures visible in MR images
- Patients with pre-existing ophthalmological condition or diabetes mellitus
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.