Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841498
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-04-25
Brief Title:
Immunoadsorption Study Mainz in Adults With Post-COVID Syndrome
Sponsor:
University Medical Center Mainz
Organization:
University Medical Center Mainz
Study Overview
Official Title:
A Single-blinded Sham-controlled Crossover Trial to Evaluate the Effect of Immunoadsorption on Post-Corona Virus Disease COVID-Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IAMPOCO
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 in each group Addendum from February 2024 An additional 40 patients with the same inclusion and exclusion criteria will be treated using the devices and materials of another manufacturer following the same design and the results will be evaluated separately 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
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 in each group Addendum from February 2024 An additional 40 patients with the same inclusion and exclusion criteria will be treated using the devices and materials of another manufacturer following the same design and the results will be evaluated separately 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
Detailed Description:
Post-COVID syndrome PCS refers to symptoms that develop 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis Soriano Murthy et al 2022 The nature of the symptoms has not been a factor in the definition of PCS The prevalence of PCS is estimated to be 43 of all severe acute respiratory syndrom coronavirus 2 SARS-COV-2-infected patients with hospitalized patients more likely to suffer from persistent symptoms 54 than non-hospitalized patients 32 Women are more likely to experience PCS than men incidence 49 vs 32 respectively Chen Haupert et al 2022 The most common symptoms are fatigue 23 memory impairment 14 dyspnea 13 sleep disturbances 11 and joint pain 10 Chen Haupert et al 2022 Headaches myalgia anxiety or depression are also frequently reported
In terms of the type variety and duration of symptoms PCS resembles a clinical picture observed after various viral infections such as Eppstein-Barr virus herpes simplex virus or influenza virus namely myalgic encephalomyelitis and chronic fatigue syndrome MECFS Here too patients mainly suffer from fatigue impaired concentration and memory and non-restorative sleep Some authors consider post-COVID as a form of MECFS triggered by the SARS-CoV-2 infection or the immune response to the infection The underlying pathophysiology likely depends on the different viruses but is incompletely understood Similarly the causes of PCS are unclear to date Autoimmunity is suspected to play a major role in all post-virus syndromes It may be triggered by the defense against infections and is probably maintained by similarity of endogenous proteins with pathogen components molecular mimicry In the context of this autoimmunity antibodies against endogenous structures can also be formed such as antinuclear antibodies which are directed against components of the cell nuclei Antibodies against α- and β-adrenergic receptors and muscarinic acetylcholine receptors among others have been detected in patients suffering from MECFS as well as in patients with PCS
Many patients are limited in their daily lives by the symptoms that develop or persist after SARS-COV-2-infection and suffer from a diminished quality of life To date there is little evidence on potential therapies for these complaints Immunoadsorption IA efficiently removes auto-antibodies from the circulation and has been proposed as a potential therapy for PCS The current trial will investigate the efficacy of IA for the treatment of PCS
40 participants with PCS and a PCFS-score of at least 2 will be included in each Each participant will undergo 5 sessions of IA with an immunoglobulin-binding adsorber and 5 sham treatments or vice versa Sham treatment will be performed in the same ways as IA but the IA device will not be set up with an adsorber The order of treatments immunoadsorption first or sham first will be randomized The participants are blinded to the order of treatments An intervention-free interval of 8 weeks will separate both treatment blocks Addendum from February 2024 40 patients additional with the same inclusion and exclusion criteria will be treated using the devices and materials of another manufacturer following the same design and the results will be evaluated separately
The primary outcome of the study is the efficacy of IA vs sham measured as changes in the PCFS 0-4 Chalder-fatigue scale 0-33 MFI-20 20-100 Bell score 0-100 montreal cognitive assesment and the hand-grip strength before therapy compared to values after immunoadsorption and after sham-treatment Secondary outcomes are 1 the number and severity of adverse events 2 the prevalence of auto-antibodies like antinuclear antibodies antibodies against adrenoreceptors and antibodies against muscarinic acetylcholine receptors in patients with PCS and 3 the change in concentration of the auto-antibodies in context of therapy and sham-treatment In addition various assessments Complete blood count with differential Antinuclear antibody Thyroid-stimulating hormone C-reactive protein Vitamin B12 Vitamin D 25-dihydroxy Ferritin Urinalysis ECG spirometry psychological questionaires will be performed during screening period to be able to exclude other diseases as the cause of the PCS symptoms In addition safety-relevant parameters such as heart rate blood pressure electrolyte concentra-tions fibrinogen concentration and the concentration of the immunoglobulin fractions are measured before and after each treatment
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
In terms of the type variety and duration of symptoms PCS resembles a clinical picture observed after various viral infections such as Eppstein-Barr virus herpes simplex virus or influenza virus namely myalgic encephalomyelitis and chronic fatigue syndrome MECFS Here too patients mainly suffer from fatigue impaired concentration and memory and non-restorative sleep Some authors consider post-COVID as a form of MECFS triggered by the SARS-CoV-2 infection or the immune response to the infection The underlying pathophysiology likely depends on the different viruses but is incompletely understood Similarly the causes of PCS are unclear to date Autoimmunity is suspected to play a major role in all post-virus syndromes It may be triggered by the defense against infections and is probably maintained by similarity of endogenous proteins with pathogen components molecular mimicry In the context of this autoimmunity antibodies against endogenous structures can also be formed such as antinuclear antibodies which are directed against components of the cell nuclei Antibodies against α- and β-adrenergic receptors and muscarinic acetylcholine receptors among others have been detected in patients suffering from MECFS as well as in patients with PCS
Many patients are limited in their daily lives by the symptoms that develop or persist after SARS-COV-2-infection and suffer from a diminished quality of life To date there is little evidence on potential therapies for these complaints Immunoadsorption IA efficiently removes auto-antibodies from the circulation and has been proposed as a potential therapy for PCS The current trial will investigate the efficacy of IA for the treatment of PCS
40 participants with PCS and a PCFS-score of at least 2 will be included in each Each participant will undergo 5 sessions of IA with an immunoglobulin-binding adsorber and 5 sham treatments or vice versa Sham treatment will be performed in the same ways as IA but the IA device will not be set up with an adsorber The order of treatments immunoadsorption first or sham first will be randomized The participants are blinded to the order of treatments An intervention-free interval of 8 weeks will separate both treatment blocks Addendum from February 2024 40 patients additional with the same inclusion and exclusion criteria will be treated using the devices and materials of another manufacturer following the same design and the results will be evaluated separately
The primary outcome of the study is the efficacy of IA vs sham measured as changes in the PCFS 0-4 Chalder-fatigue scale 0-33 MFI-20 20-100 Bell score 0-100 montreal cognitive assesment and the hand-grip strength before therapy compared to values after immunoadsorption and after sham-treatment Secondary outcomes are 1 the number and severity of adverse events 2 the prevalence of auto-antibodies like antinuclear antibodies antibodies against adrenoreceptors and antibodies against muscarinic acetylcholine receptors in patients with PCS and 3 the change in concentration of the auto-antibodies in context of therapy and sham-treatment In addition various assessments Complete blood count with differential Antinuclear antibody Thyroid-stimulating hormone C-reactive protein Vitamin B12 Vitamin D 25-dihydroxy Ferritin Urinalysis ECG spirometry psychological questionaires will be performed during screening period to be able to exclude other diseases as the cause of the PCS symptoms In addition safety-relevant parameters such as heart rate blood pressure electrolyte concentra-tions fibrinogen concentration and the concentration of the immunoglobulin fractions are measured before and after each treatment
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None