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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705831
• Other study ID #: IIS202001-Neuroimmune
• Status: Recruiting
• Phase: Phase 4
• Start date: December 30, 2020
• Est. completion date: January 2022

Study information

• Verified date: January 2021
• Source: IMMUNOe Research Centers
• Contact: Maureen Collins
• Phone: 303-771-9000
• Email: mcollins[@]immunoe.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 and older, male or female

2. Previous confirmed diagnosis of SARS-CoV-2

3. Experiencing SARS-CoV-2 post-viral fatigue syndrome 4 weeks after recovery for SARS-CoV-2

4. Experiencing neurological symptoms including fatigue

5. Willing to comply with all aspects of the protocol, including blood draws

6. Patient is able to understand and fully participate in the activities of the study and the consent in accordance with guidelines

7. 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:

1. Receiving any form of C1-INH therapy either acute or prophylactic treatment

2. History or suspicion of allergy to rabbits

3. Neurological conditions related to injury

4. Neuropathy related to diabetes

5. Participants who are pregnant or lactating

6. Largely incapacitated or bed ridden

7. 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

8. Patients who, in the investigator's opinion, might not be suitable for the trial for safety reasons

Related Conditions & MeSH terms

• Covid19
• Fatigue
• Fatigue Syndrome, Chronic
• Post-Viral Disorder (Disorder)
• Post-Viral Fatigue Syndrome

Intervention

Drug:
• Ruconest
C1 Esterase Inhibitor

Locations

Country	Name	City	State
United States	IMMUNOe Research Centers	Centennial	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
IMMUNOe Research Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological Measures (BRIEF-A)	Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)	Week 0
Primary	Neuropsychological Measures (BRIEF-A)	Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)	Week 9
Primary	Neuropsychological Measures (BRIEF-A)	Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)	Week 17
Primary	Neuropsychological Measures (RBANS)	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Week 0
Primary	Neuropsychological Measures (RBANS)	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Week 9
Primary	Neuropsychological Measures (RBANS)	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Week 17
Primary	Neuropsychological Measures (BDI II)	Beck Depression Inventory II (BDI II)	Week 0
Primary	Neuropsychological Measures (BDI II)	Beck Depression Inventory II (BDI II)	Week 9
Primary	Neuropsychological Measures (BDI II)	Beck Depression Inventory II (BDI II)	Week 17
Primary	Neuropsychological Measures (MoCA)	Montreal Cognitive Assessment (MoCA)	Week 0
Primary	Neuropsychological Measures (MoCA)	Montreal Cognitive Assessment (MoCA)	Week 9
Primary	Neuropsychological Measures (MoCA)	Montreal Cognitive Assessment (MoCA)	Week 17
Primary	Patient-Rate Questionnaires (FSS)	Fatigue Severity Scale (FSS)	Week 0
Primary	Patient-Rate Questionnaires (FSS)	Fatigue Severity Scale (FSS)	Week 5
Primary	Patient-Rate Questionnaires (FSS)	Fatigue Severity Scale (FSS)	Week 9
Primary	Patient-Rate Questionnaires (FSS)	Fatigue Severity Scale (FSS)	Week 14
Primary	Patient-Rate Questionnaires (FSS)	Fatigue Severity Scale (FSS)	Week 17
Primary	Patient-Rate Questionnaires (MIDAS)	Migraine Disability Assessment (MIDAS)	Week 0
Primary	Patient-Rate Questionnaires (MIDAS)	Migraine Disability Assessment (MIDAS)	Week 5
Primary	Patient-Rate Questionnaires (MIDAS)	Migraine Disability Assessment (MIDAS)	Week 9
Primary	Patient-Rate Questionnaires (MIDAS)	Migraine Disability Assessment (MIDAS)	Week 14
Primary	Patient-Rate Questionnaires (MIDAS)	Migraine Disability Assessment (MIDAS)	Week 17
Primary	Patient-Rate Questionnaires (HIT)	Headache Impact Scale (HIT)	Week 0
Primary	Patient-Rate Questionnaires (HIT)	Headache Impact Scale (HIT)	Week 5
Primary	Patient-Rate Questionnaires (HIT)	Headache Impact Scale (HIT)	Week 9
Primary	Patient-Rate Questionnaires (HIT)	Headache Impact Scale (HIT)	Week 14
Primary	Patient-Rate Questionnaires (HIT)	Headache Impact Scale (HIT)	Week 17
Primary	Patient-Rate Questionnaires (Activities)	Activities of Daily Living Sliding Scale and Questionnaire	Week 0
Primary	Patient-Rate Questionnaires (Activities)	Activities of Daily Living Sliding Scale and Questionnaire	Week 5
Primary	Patient-Rate Questionnaires (Activities)	Activities of Daily Living Sliding Scale and Questionnaire	Week 9
Primary	Patient-Rate Questionnaires (Activities)	Activities of Daily Living Sliding Scale and Questionnaire	Week 14
Primary	Patient-Rate Questionnaires (Activities)	Activities of Daily Living Sliding Scale and Questionnaire	Week 17
Primary	Patient-Rate Questionnaires (SF)	SF McGill Pain Questionnaire	Week 0
Primary	Patient-Rate Questionnaires (SF)	SF McGill Pain Questionnaire	Week 5
Primary	Patient-Rate Questionnaires (SF)	SF McGill Pain Questionnaire	Week 9
Primary	Patient-Rate Questionnaires (SF)	SF McGill Pain Questionnaire	Week 14
Primary	Patient-Rate Questionnaires (SF)	SF McGill Pain Questionnaire	Week 17
Primary	Patient-Rate Questionnaires (GSRS)	Gastrointestinal Symptoms Rating Scale (GSRS)	Week 0
Primary	Patient-Rate Questionnaires (GSRS)	Gastrointestinal Symptoms Rating Scale (GSRS)	Week 5
Primary	Patient-Rate Questionnaires (GSRS)	Gastrointestinal Symptoms Rating Scale (GSRS)	Week 9
Primary	Patient-Rate Questionnaires (GSRS)	Gastrointestinal Symptoms Rating Scale (GSRS)	Week 14
Primary	Patient-Rate Questionnaires (GSRS)	Gastrointestinal Symptoms Rating Scale (GSRS)	Week 17
Primary	Patient-Rate Questionnaires (SF-36)	SF-36	Week 0
Primary	Patient-Rate Questionnaires (SF-36)	SF-36	Week 5
Primary	Patient-Rate Questionnaires (SF-36)	SF-36	Week 9
Primary	Patient-Rate Questionnaires (SF-36)	SF-36	Week 14
Primary	Patient-Rate Questionnaires (SF-36)	SF-36	Week 17
Primary	Neurological Exam (0)	Complete neurological examination	Week 0
Primary	Neurological Exam (9)	Complete neurological examination	Week 9
Primary	Neurological Exam (17)	Complete neurological examination	Week 17
Primary	Immunological Biomarkers (Toll)	Toll Like Receptor Function Assay	Week 1
Primary	Immunological Biomarkers (Toll)	Toll Like Receptor Function Assay	Week 9
Primary	Immunological Biomarkers (Toll)	Toll Like Receptor Function Assay	Week 17
Primary	Immunological Biomarkers (GAD)	GAD-65	Week 1
Primary	Immunological Biomarkers (GAD)	GAD-65	Week 9
Primary	Immunological Biomarkers (GAD)	GAD-65	Week 17
Primary	Immunological Biomarkers (Com)	Complement Panel (C4, C1-INH, C1-INH Function)	Week 1
Primary	Immunological Biomarkers (Com)	Complement Panel (C4, C1-INH, C1-INH Function)	Week 9
Primary	Immunological Biomarkers (Com)	Complement Panel (C4, C1-INH, C1-INH Function)	Week 17
Primary	Immunological Biomarkers (Ig)	Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)	Week 1
Primary	Immunological Biomarkers (Ig)	Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)	Week 9
Primary	Immunological Biomarkers (Ig)	Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)	Week 17
Primary	Immunological Biomarkers (IgG)	Immunoglobulins G, Subclasses (1-4)	Week 1
Primary	Immunological Biomarkers (IgG)	Immunoglobulins G, Subclasses (1-4)	Week 9
Primary	Immunological Biomarkers (IgG)	Immunoglobulins G, Subclasses (1-4)	Week 17
Primary	Immunological Biomarkers (TH/TH)	TH1/TH2 Cytokine Levels	Week 1
Primary	Immunological Biomarkers (TH/TH)	TH1/TH2 Cytokine Levels	Week 9
Primary	Immunological Biomarkers (TH/TH)	TH1/TH2 Cytokine Levels	Week 17