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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ruconest
Sponsored by
IMMUNOe Research Centers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Viral Fatigue Syndrome focused on measuring Post-COVID Symptoms, Post-Viral Fatigue Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IMMUNOe Research CentersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RUCONEST

Placebo

Arm Description

IV Ruconest

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 7, 2021
Last Updated
January 8, 2021
Sponsor
IMMUNOe Research Centers
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1. Study Identification

Unique Protocol Identification Number
NCT04705831
Brief Title
Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IMMUNOe Research Centers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Viral Fatigue Syndrome, Post-Viral Disorder (Disorder), Covid19
Keywords
Post-COVID Symptoms, Post-Viral Fatigue Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen Collins
Phone
303-771-9000
Ext
1248
Email
mcollins@immunoe.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Palm
Phone
303-225-0087
Email
apalm@immunoe.com
Facility Information:
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen Collins
Phone
303-771-9000
Ext
1248
Email
mcollins@immunoe.com
First Name & Middle Initial & Last Name & Degree
Isaac Melamed, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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