Immunoadsorption-study Mainz in adults with Post-COVID-syndrome (IAMPOCO)
Laufzeit: 01.01.2023 - 31.12.2025
Kurzfassung
The aim of this study is to evaluate the effectiveness and safety of immunoadsorption for the therapy of symptoms due to a Post-COVID-syndrome.
The therapeutic effectiveness will be measured (1) subjective 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) objective as an improvement in neurocognitive...The aim of this study is to evaluate the effectiveness and safety of immunoadsorption for the therapy of symptoms due to a Post-COVID-syndrome.
The therapeutic effectiveness will be measured (1) subjective 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) objective as an improvement in neurocognitive testing with the Montreal cognitive assessment (MoCA) and the improvement of the gripping strength.
40 participants with symptoms of a Post-COVID-syndrome and a PCFS-score of at least 2 should be included. After a screening for other causes of the symptoms than Post-COVID 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. Which treatment (immunoadsorption or sham) a participant gets first will be randomized and each participant will be blinded for the modality of the conducted treatment. Between immunoadsorption and the sham treatment will be a therapy-free period of 8 weeks. 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 may help to improve the advice and therapy of the numerous patients with restricting symptoms months after a SARS-COV-2-infection and may contribute to a better understanding of the pathophysiological insights behind the ongoing symptoms» weiterlesen» einklappen