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Randomized, Double Blind, Placebo Controlled, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection.
This study will last approximately 19 weeks including 16 infusions total, each one week apart. This is to help patients that have developed "Post-Viral Fatigue Syndrome" which can include symptoms such as: extreme fatigue, lost of taste, brain fog, and/or seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RUCONEST | Active Comparator | IV Ruconest |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruconest | Drug | C1 Esterase Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Measures (BRIEF-A) | Behavior Rating Inventory of Executive Function- Adult (BRIEF-A) | Week 0 |
| Neuropsychological Measures (BRIEF-A) | Behavior Rating Inventory of Executive Function- Adult (BRIEF-A) | Week 9 |
| Neuropsychological Measures (BRIEF-A) | Behavior Rating Inventory of Executive Function- Adult (BRIEF-A) | Week 17 |
| Neuropsychological Measures (RBANS) | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Week 0 |
| Neuropsychological Measures (RBANS) | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Week 9 |
| Neuropsychological Measures (RBANS) | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Week 17 |
| Neuropsychological Measures (BDI II) | Beck Depression Inventory II (BDI II) | Week 0 |
| Neuropsychological Measures (BDI II) | Beck Depression Inventory II (BDI II) | Week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41281561 | Derived | Melamed I, Buckley C, Bayko ME, Williams JL, Or-Geva N. Does C1 esterase inhibitor play a role in post COVID-19 neurological symptoms? A randomized, double-blind, placebo-controlled, crossover, proof-of-concept study. Front Neurol. 2025 Nov 6;16:1523814. doi: 10.3389/fneur.2025.1523814. eCollection 2025. |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| C571093 | conestat alfa |
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| Neuropsychological Measures (BDI II) | Beck Depression Inventory II (BDI II) | Week 17 |
| Neuropsychological Measures (MoCA) | Montreal Cognitive Assessment (MoCA) | Week 0 |
| Neuropsychological Measures (MoCA) | Montreal Cognitive Assessment (MoCA) | Week 9 |
| Neuropsychological Measures (MoCA) | Montreal Cognitive Assessment (MoCA) | Week 17 |
| Patient-Rate Questionnaires (FSS) | Fatigue Severity Scale (FSS) | Week 0 |
| Patient-Rate Questionnaires (FSS) | Fatigue Severity Scale (FSS) | Week 5 |
| Patient-Rate Questionnaires (FSS) | Fatigue Severity Scale (FSS) | Week 9 |
| Patient-Rate Questionnaires (FSS) | Fatigue Severity Scale (FSS) | Week 14 |
| Patient-Rate Questionnaires (FSS) | Fatigue Severity Scale (FSS) | Week 17 |
| Patient-Rate Questionnaires (MIDAS) | Migraine Disability Assessment (MIDAS) | Week 0 |
| Patient-Rate Questionnaires (MIDAS) | Migraine Disability Assessment (MIDAS) | Week 5 |
| Patient-Rate Questionnaires (MIDAS) | Migraine Disability Assessment (MIDAS) | Week 9 |
| Patient-Rate Questionnaires (MIDAS) | Migraine Disability Assessment (MIDAS) | Week 14 |
| Patient-Rate Questionnaires (MIDAS) | Migraine Disability Assessment (MIDAS) | Week 17 |
| Patient-Rate Questionnaires (HIT) | Headache Impact Scale (HIT) | Week 0 |
| Patient-Rate Questionnaires (HIT) | Headache Impact Scale (HIT) | Week 5 |
| Patient-Rate Questionnaires (HIT) | Headache Impact Scale (HIT) | Week 9 |
| Patient-Rate Questionnaires (HIT) | Headache Impact Scale (HIT) | Week 14 |
| Patient-Rate Questionnaires (HIT) | Headache Impact Scale (HIT) | Week 17 |
| Patient-Rate Questionnaires (Activities) | Activities of Daily Living Sliding Scale and Questionnaire | Week 0 |
| Patient-Rate Questionnaires (Activities) | Activities of Daily Living Sliding Scale and Questionnaire | Week 5 |
| Patient-Rate Questionnaires (Activities) | Activities of Daily Living Sliding Scale and Questionnaire | Week 9 |
| Patient-Rate Questionnaires (Activities) | Activities of Daily Living Sliding Scale and Questionnaire | Week 14 |
| Patient-Rate Questionnaires (Activities) | Activities of Daily Living Sliding Scale and Questionnaire | Week 17 |
| Patient-Rate Questionnaires (SF) | SF McGill Pain Questionnaire | Week 0 |
| Patient-Rate Questionnaires (SF) | SF McGill Pain Questionnaire | Week 5 |
| Patient-Rate Questionnaires (SF) | SF McGill Pain Questionnaire | Week 9 |
| Patient-Rate Questionnaires (SF) | SF McGill Pain Questionnaire | Week 14 |
| Patient-Rate Questionnaires (SF) | SF McGill Pain Questionnaire | Week 17 |
| Patient-Rate Questionnaires (GSRS) | Gastrointestinal Symptoms Rating Scale (GSRS) | Week 0 |
| Patient-Rate Questionnaires (GSRS) | Gastrointestinal Symptoms Rating Scale (GSRS) | Week 5 |
| Patient-Rate Questionnaires (GSRS) | Gastrointestinal Symptoms Rating Scale (GSRS) | Week 9 |
| Patient-Rate Questionnaires (GSRS) | Gastrointestinal Symptoms Rating Scale (GSRS) | Week 14 |
| Patient-Rate Questionnaires (GSRS) | Gastrointestinal Symptoms Rating Scale (GSRS) | Week 17 |
| Patient-Rate Questionnaires (SF-36) | SF-36 | Week 0 |
| Patient-Rate Questionnaires (SF-36) | SF-36 | Week 5 |
| Patient-Rate Questionnaires (SF-36) | SF-36 | Week 9 |
| Patient-Rate Questionnaires (SF-36) | SF-36 | Week 14 |
| Patient-Rate Questionnaires (SF-36) | SF-36 | Week 17 |
| Neurological Exam (0) | Complete neurological examination | Week 0 |
| Neurological Exam (9) | Complete neurological examination | Week 9 |
| Neurological Exam (17) | Complete neurological examination | Week 17 |
| Immunological Biomarkers (Toll) | Toll Like Receptor Function Assay | Week 1 |
| Immunological Biomarkers (Toll) | Toll Like Receptor Function Assay | Week 9 |
| Immunological Biomarkers (Toll) | Toll Like Receptor Function Assay | Week 17 |
| Immunological Biomarkers (GAD) | GAD-65 | Week 1 |
| Immunological Biomarkers (GAD) | GAD-65 | Week 9 |
| Immunological Biomarkers (GAD) | GAD-65 | Week 17 |
| Immunological Biomarkers (Com) | Complement Panel (C4, C1-INH, C1-INH Function) | Week 1 |
| Immunological Biomarkers (Com) | Complement Panel (C4, C1-INH, C1-INH Function) | Week 9 |
| Immunological Biomarkers (Com) | Complement Panel (C4, C1-INH, C1-INH Function) | Week 17 |
| Immunological Biomarkers (Ig) | Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM) | Week 1 |
| Immunological Biomarkers (Ig) | Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM) | Week 9 |
| Immunological Biomarkers (Ig) | Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM) | Week 17 |
| Immunological Biomarkers (IgG) | Immunoglobulins G, Subclasses (1-4) | Week 1 |
| Immunological Biomarkers (IgG) | Immunoglobulins G, Subclasses (1-4) | Week 9 |
| Immunological Biomarkers (IgG) | Immunoglobulins G, Subclasses (1-4) | Week 17 |
| Immunological Biomarkers (TH/TH) | TH1/TH2 Cytokine Levels | Week 1 |
| Immunological Biomarkers (TH/TH) | TH1/TH2 Cytokine Levels | Week 9 |
| Immunological Biomarkers (TH/TH) | TH1/TH2 Cytokine Levels | Week 17 |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |