Post-COVID-19 Syndrome Clinical Trial
— IAMPOCOOfficial title:
A Single-blinded Sham-controlled Crossover Trial to Evaluate the Effect of Immunoadsorption on Post-Corona Virus Disease (COVID)-Syndrome
NCT number | NCT05841498 |
Other study ID # | IAMPOCO |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2023 |
Est. completion date | December 2024 |
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. The study comprises 2 sub-studies, each with an identical design, including 40 participants each. The only difference between the sub-studies is the systems and adsorbers used for immunoadsorption and sham treatment. Participants with symptoms of PCS and a PCFS score of at least 2 will be included in each group. After excluding other causes of the symptoms and evaluating 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 to the type of treatment they receive. An 8-week therapy-free period 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, and 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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Meeting the WHO diagnostic criteria for PCS - Written informed consent to participate in the study - Previous participation in the Gutenberg Post-Covid Study or previously conducted comparable preliminary examinations - Minimum age of 18 years - Value on the Post-COVID functional scale of at least 2 Exclusion Criteria: - Psychiatric diagnosis - Allergy to adsorber materials, materials of the tubing systems or to the substances used for immunoadsorption - Pregnancy - Medical contraindications to immunoadsorption such as severe blood clotting disorders or immunodeficiency syndromes - Existing antibody-mediated autoimmune disease - Intake of ACE-inhibitors 7 days prior to the inclusion in to the study or during the study period |
Country | Name | City | State |
---|---|---|---|
Germany | UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik | Mainz | Rheinland-Pfalz |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Mainz |
Germany,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of Post-COVID symptoms as measured by PCFS score | The PCFS serves as a self-report instrument to better objectify perceived symptom severity at Post-COVID. Patients are asked to describe states presented as a questionnaire. A value is assigned to each described state. The greater the symptom severity is described by the condition, the greater the score from 0-4. The PCFS has been validated in cohorts of patients with Post-COVID-syndrome and is therefore particularly suitable for assessing symptom severity. | 2 weeks after completion of immunoadsorption and sham-apheresis | |
Primary | Change of physical and/or mental fatigue as measured by Chalder-Fatigue-scale | The Chalder Fatigue Scale is an 11-item question battery that captures two dimensions of fatigue symptomatology, both the assessment of physical functioning and the assessment of mental functioning. Each question is answered using a 4-point Likert scale. The answering takes an average of 2-3 minutes and a re-survey can be done every 4 weeks. | 2 weeks after completion of immunoadsorption and sham-apheresis | |
Primary | Change of impairment due to fatigue as measured by Bell-Score | The Bell score is an assessment instrument that can be collected by both the patient and the examiner and measures the degree of restriction in daily life caused by fatigue symptoms. In 11 grades, the restriction can be indicated from 0 (bedridden) to 100 (no restrictions, normal resilience in all activities of daily living). | 2 weeks after completion of immunoadsorption and sham-apheresis | |
Primary | Change of physical and/or mental fatigue as measured by MFI-20 | The MFI-20 captures the phenomenon of fatigue in the 5 subscales general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. It is a self-report questionnaire in which patients rate statements such as "I was able to concentrate well" or "I was rested" in 5 levels for the latter time, including today. The result is a score in the range from 20-100 whereby a higher score indicates more severe fatigue. | 2 weeks after completion of immunoadsorption and sham-apheresis | |
Primary | Change of Hand grip strength measured as hand-grip-strength test with a dynamometer | Grip strength serves as a surrogate parameter for physical performance or changes in it. Grip strength is measured three times on each hand in neutral position using a dynamometer and the mean value is documented. | 2 weeks after completion of immunoadsorption and sham-apheresis | |
Primary | Change of cognitive impairment as measured by Montreal cognitive assesment (MoCA) | The Montreal Cognitive Assessment (MocA) is used to test various neurocognitive functions. It is a ten-minute test with various tasks that can be scored with a total of up to 30 points. It tests abilities in the areas of memory, attention, verbal abstraction, visuospatial abilities, concentration and language comprehension. | 2 weeks after completion of immunoadsorption and sham-apheresis | |
Secondary | number of treatment-emergent adverse events (TEAE), serious adverse events and discontinuation of therapy because of adverse events | 1. The number of treatment-emergent adverse events (TEAE), serious adverse events and discontinuation of therapy because of adverse events and the comparison of them under immunoadsorption with the number of events under sham apheresis. Events are recorded for comparison two weeks after the end of each treatment cycle. | 2 weeks after completion of immunoadsorption and sham-apheresis | |
Secondary | Prevalence of anti-adrenergic and anti-muscarinic autoantibodies in patients with PCS: | Proportion of subjects with evidence of anti-a1-adrenoreceptor antibodies (AB)
Proportion of subjects with evidence of anti-a2-adrenoreceptor AB Proportion of subjects with evidence of anti-ß1-adrenoreceptor-AB Proportion of subjects with evidence of anti-ß2-adrenoreceptor AB Proportion of subjects with evidence of anti-ß3-adrenoreceptor-AB Proportion of subjects with detection of anti- M1 acetylcholine receptor AB Proportion of subjects with detection of anti-M2 acetylcholine receptor AB Proportion of subjects with detection of anti-M3 acetylcholine receptor-AB Proportion of subjects with detection of anti-M4 acetylcholine receptor-AB |
at the time of the first examination before randomization for the first treatment-modality | |
Secondary | 3. Concentration of autoantibodies before and after IA and sham treatment (before therapy cycle 1/after therapy cycle1 as well as before therapy cycle 2/after therapy cycle 2) | Concentration anti-a1-adrenoreceptor antibodies (AB)
Concentration of anti-a2-adrenoreceptor AB Concentration of anti-ß1-adrenoreceptor-AB Concentration of anti-ß2-adrenoreceptor AB Concentration of anti-ß3-adrenoreceptor-AB Concentration of anti- M1 acetylcholine receptor AB Concentration of anti-M2 acetylcholine receptor AB Concentration of anti-M3 acetylcholine receptor-AB Concentration of anti-M4 acetylcholine receptor-AB |
before therapy cycle 1/after therapy cycle1 as well as before therapy cycle 2/after therapy cycle 2 |
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