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

NCT ID: NCT05954325

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2025-07-31

Brief 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.

Conditions

Fatigue; Post-Acute COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Immunoadsorption

5 immunoadsorption treatments

Group Type: EXPERIMENTAL

Immunoadsorption vs. sham immunoadsorption

Intervention Type: PROCEDURE

5 treatments within 14 days

Sham immunoadsorption

5 sham immunoadsorption treatments

Group Type: SHAM_COMPARATOR

Immunoadsorption vs. sham immunoadsorption

Intervention Type: PROCEDURE

5 treatments within 14 days

Interventions

Immunoadsorption vs. sham immunoadsorption

5 treatments within 14 days

Intervention Type: PROCEDURE

Other Intervention Names

Apheresis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Goedecke, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School, Department of Nephrology and Hypertension

Locations

Hannover Medical School

Hanover, Lower Saxony, Germany

Countries

Germany

Other Identifiers

EXTINCT post COVID

Identifier Type: -

Identifier Source: org_study_id