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Immunoadsorption vs Sham Treatment in Post-COVID-19 Patients With Chronic Fatigue Syndrome (EXTINCT post COVID)

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2023-07
Completion (planned):
2025-06
Last update:
2023-12-01

 

Research types:
Clinical research
Research areas:
Immune system dysfunction
Interventions:
TheraSorb®, Immunoadsorption, Sham procedure
Priv. Sector Partner:
Not available
Sponsors:

Project description

The complex clinical symptoms of post-COVID syndrome (PCS), 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 PCS. 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.

The investigators 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 PCS, while at the same time providing basic research evidence for an understanding of the pathogenesis of PCS. Thereby, the investigators expect to obtain important insights into the diagnosis, treatment and pathophysiology of PCS.

(Description adapted from clinical trial website: see link above)

Patient cohort

Post-COVID ME/CFS according to Canadian Consensus Criteria (CCC).

Patients enrolled: 60

Age group: 18 - 75 years (Older Adults, Adults)

Research areas
3
Research types
1
Research networks
1
Working groups
1
People
2
Publications
0
Organisations
1