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

NCT05954325 | Completed

• 1 other identifier: EXTINCT post COVID
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Keywords

Post COVID syndrome; Fatigue; Immunoadsorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Cognitive Function

  12 weeks

• Post exertional malaise symptoms

  12 weeks

• Measure of health status

  12 weeks

• Depression and Anxiety

  12 weeks

• Autonomic dysfunction

  12 weeks

Other Outcomes (1)

• Safety and tolerability of immunoadsorption treatment

  12 weeks

Study Arms (2)

Immunoadsorption

EXPERIMENTAL

5 immunoadsorption treatments

Procedure: Immunoadsorption vs. sham immunoadsorption

Sham immunoadsorption

SHAM COMPARATOR

5 sham immunoadsorption treatments

Procedure: Immunoadsorption vs. sham immunoadsorption

Interventions

Immunoadsorption vs. sham immunoadsorption PROCEDURE

5 treatments within 14 days

Also known as: Apheresis

Immunoadsorption; Sham immunoadsorption

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Fatigue; Post-Acute COVID-19 Syndrome

Interventions

Blood Component Removal

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dr. Goedecke, MD

  Hannover Medical School, Department of Nephrology and Hypertension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, randomized, sham-controlled trial

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 20, 2023
• Study Start: August 15, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)