Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled, Cross-Over, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST (C1 Esterase Inhibitor [Recombinant]) in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection

Conditions
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Post-Viral Fatigue Syndrome, Post-Viral Disorder (Disorder), Covid19

Intervention / Treatment
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* Drug: Ruconest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older, male or female Previous confirmed diagnosis of SARS-CoV-2 Experiencing SARS-CoV-2 post-viral fatigue syndrome 4 weeks after recovery for SARS-CoV-2 Experiencing neurological symptoms including fatigue Willing to comply with all aspects of the protocol, including blood draws Patient is able to understand and fully participate in the activities of the study and the consent in accordance with guidelines Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate of < 1% when properly applied and include: a combination pill, some intra-uterine devices, and a sterilized partner in a stable relationship. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire period. Exclusion Criteria: Receiving any form of C1-INH therapy either acute or prophylactic treatment History or suspicion of allergy to rabbits Neurological conditions related to injury Neuropathy related to diabetes Participants who are pregnant or lactating Largely incapacitated or bed ridden Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study or have discontinued with 30 days of study entry from any other clinical study involving an investigational product Patients who, in the investigator's opinion, might not be suitable for the trial for safety reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RUCONEST<br>IV Ruconest | Drug: Ruconest<br>* C1 Esterase Inhibitor<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Ruconest<br>* C1 Esterase Inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-COVID Symptoms, Post-Viral Fatigue Syndrome