Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source University Medical Center Mainz
Contact Julia Weinmann-Menke, Prof. MD
Phone +496131172462
Email julia.weinmann-menke@unimedizin-mainz.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Read more »

Locations

Country Name City State
Germany UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik Mainz Rheinland-Pfalz

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (7)

See more »

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT06073002 - Effects of a Home-Based Exercise Intervention in Subjects With Long COVID N/A
Completed NCT05047952 - Vortioxetine for Post-COVID-19 Condition Phase 2
Completed NCT05812209 - Stellate Ganglion Block to Treat Long COVID 19 Case Series
Recruiting NCT06091384 - Inspiratory Muscle Strength Training in Post-Covid Syndrome N/A
Not yet recruiting NCT06267300 - Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial Phase 3
Recruiting NCT05986422 - Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) Phase 2
Not yet recruiting NCT05534997 - Rehabilitation Therapy for Post COVID 19 Chronic Fatigue Syndrome N/A
Recruiting NCT05638633 - Prednisolone and Vitamin B1/6/12 in Patients With Post-Covid-Syndrome Phase 3
Active, not recruiting NCT05630040 - VNS for Long-COVID-19 N/A
Enrolling by invitation NCT05981872 - EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19 N/A
Active, not recruiting NCT05543408 - Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial" N/A
Recruiting NCT05817032 - Effect of Telerehabilitation Practice in Long COVID-19 Patients N/A
Recruiting NCT05823896 - imPROving Quality of LIFe In the Long COVID Patient Phase 2
Completed NCT05764070 - Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post SARS-CoV-2 Patients N/A
Completed NCT05765591 - Balneotherapy for Patients With Post-acute Coronavirus Disease (COVID) Syndrome N/A
Recruiting NCT05918965 - Vagus Stimulation in Female Long COVID Patients. N/A
Not yet recruiting NCT06231238 - Balance Acceptance and Commitment Therapy for Long COVID Phase 2
Completed NCT06282627 - The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients
Completed NCT05648734 - Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis
Active, not recruiting NCT05753202 - tDCS in Post-COVID Syndrome: Comparison of Two Targets N/A