Immunoadsorption Study Mainz in Adults With Post-COVID Syndrome (IAMPOCO)

Sly Saint

Senior Member (Voting Rights)
Sponsor:
University Medical Center Mainz
Information provided by (Responsible Party):
Prof. Dr. Julia Weinmann-Menke, University Medical Center Mainz

Brief Summary:
The aim of this study is to evaluate the efficiency and safety of immunoadsorption for the treatment of post-COVID syndrome (PCS).

Efficacy will be measured (1) subjectively as an improvement of the score of questionnaires like the multidimensional fatigue inventory (MFI-20), Chalder fatigue scale, Bell-score, modified medical research council dyspnea scale (mMRC) and the Post-COVID functional scale (PCFS) and (2) objectively as an improvement in neurocognitive testing with the Montreal cognitive assessment (MoCA) and the improvement of the hand-grip strength.

40 participants with symptoms of PCS and a PCFS score of at least 2 will be included. After an exclusion of other causes of the symptoms and evaluation of the baseline burden of symptoms each participant will undergo 5 sessions of immunoadsorption with an immunoglobulin-binding adsorber and 5 sham-treatments or vice versa. The order of treatments (immunoadsorption first or sham first) will be randomized. Each participant will be blinded for the modality of the conducted treatment. A therapy-free period of 8 weeks will separate the two treatment blocks. All examinations will be conducted before the first treatment, 2 weeks after the first treatment cycle, before the second treatment cycle as well as 2 and 6 weeks after the second treatment cycle.

The results of the study will inform future treatment strategies for PCS and will contribute to a better understanding of the pathophysiological insights behind the ongoing symptoms.

https://clinicaltrials.gov/ct2/show/NCT05841498
 
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