Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2 : Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2 (IN-PASC)
Study Description:This study will evaluate the clinical and laboratory effects of immunoglobulin therapy in patients who recovered from acute mildmoderate COVID-19 infection but still have persistent neurologic symptoms. Despite clinical recovery from the acute infection, some individuals continue to experience ongoing symptoms, at times several months after recovery, and many of these symptoms are neurologic. Some features suggest that this is a post-infectious immune-mediated process, and anecdotally patients have responded well to immunoglobulin therapy. This study will evaluate the clinical and laboratory effects of intravenous immunoglobulin therapy compared to placebo using a cross-over trial design. It is hypothesized that immunoglobulin therapy could have positive clinical and laboratory effects on patients with persistent neurological symptoms.Objectives:Primary Objective: To compare the clinical efficacy of intravenous immunoglobulin therapy to placebo in ameliorating the neurological post-acute sequalae of SARS-CoV-2 infection.Secondary objective: To determine the clinical effects of intravenous immunoglobulin therapy in patients with neurological post-acute sequalae of SARS-CoV-2 infection.Exploratory objective: To investigate the laboratory effects of intravenous immunoglobulin therapy in patients with neurological post-acute sequalae of SARS-CoV-2 infection.Endpoints:Primary endpoint:Proportion of participants with a clinically meaningful change in Health Utilities Index Mark 3 (HUI3) 2 weeks after intravenous immunoglobulin therapy compared with 2 weeks after placebo.Secondary endpoints:Change in functional / patient-reported scales:WHO post COVID-19 functional scalePost-COVID-19 Functional Status (PCFS) scale (0-4).COVID-19 Yorkshire Rehabilitation ScalePROMIS Global Health scorePROMIS Depression scorePROMIS anxiety scoreChange in clinical scales:Montreal Cognitive Assessment (MoCA)Brief tablet-based Neuropsychiatric evaluationKarnofsky Performance Status (KPS)Exploratory endpoints:Autonomic testing Change in the number and character of test results indicating autonomic nervous system dysfunctions as evidenced by abnormal physiological and neurochemical measures at rest or in responses to the Valsalva maneuver or head-up tilting.Change in immunological markers:Cytokine levelsCell markers per flow cytometrySCENTinel, Olfactory testing, Monell.
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 15. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: April 28, 2022, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024 |
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| Study ID: |
NCT05350774 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG008413800 |
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| 520 | |a Study Description:This study will evaluate the clinical and laboratory effects of immunoglobulin therapy in patients who recovered from acute mildmoderate COVID-19 infection but still have persistent neurologic symptoms. Despite clinical recovery from the acute infection, some individuals continue to experience ongoing symptoms, at times several months after recovery, and many of these symptoms are neurologic. Some features suggest that this is a post-infectious immune-mediated process, and anecdotally patients have responded well to immunoglobulin therapy. This study will evaluate the clinical and laboratory effects of intravenous immunoglobulin therapy compared to placebo using a cross-over trial design. It is hypothesized that immunoglobulin therapy could have positive clinical and laboratory effects on patients with persistent neurological symptoms.Objectives:Primary Objective: To compare the clinical efficacy of intravenous immunoglobulin therapy to placebo in ameliorating the neurological post-acute sequalae of SARS-CoV-2 infection.Secondary objective: To determine the clinical effects of intravenous immunoglobulin therapy in patients with neurological post-acute sequalae of SARS-CoV-2 infection.Exploratory objective: To investigate the laboratory effects of intravenous immunoglobulin therapy in patients with neurological post-acute sequalae of SARS-CoV-2 infection.Endpoints:Primary endpoint:Proportion of participants with a clinically meaningful change in Health Utilities Index Mark 3 (HUI3) 2 weeks after intravenous immunoglobulin therapy compared with 2 weeks after placebo.Secondary endpoints:Change in functional / patient-reported scales:WHO post COVID-19 functional scalePost-COVID-19 Functional Status (PCFS) scale (0-4).COVID-19 Yorkshire Rehabilitation ScalePROMIS Global Health scorePROMIS Depression scorePROMIS anxiety scoreChange in clinical scales:Montreal Cognitive Assessment (MoCA)Brief tablet-based Neuropsychiatric evaluationKarnofsky Performance Status (KPS)Exploratory endpoints:Autonomic testing Change in the number and character of test results indicating autonomic nervous system dysfunctions as evidenced by abnormal physiological and neurochemical measures at rest or in responses to the Valsalva maneuver or head-up tilting.Change in immunological markers:Cytokine levelsCell markers per flow cytometrySCENTinel, Olfactory testing, Monell | ||
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