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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04705831
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Isaac Melamed, MD, IMMUNOe Research Centers

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.

Condition or disease Intervention/treatment Phase
Post-Viral Fatigue Syndrome Post-Viral Disorder (Disorder) Covid19 Drug: Ruconest Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Active Comparator: RUCONEST
IV Ruconest
Drug: Ruconest
C1 Esterase Inhibitor

Placebo Comparator: Placebo
Placebo
Drug: Ruconest
C1 Esterase Inhibitor




Primary Outcome Measures :
  1. Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 0 ]
    Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)

  2. Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 9 ]
    Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)

  3. Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 17 ]
    Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)

  4. Neuropsychological Measures (RBANS) [ Time Frame: Week 0 ]
    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  5. Neuropsychological Measures (RBANS) [ Time Frame: Week 9 ]
    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  6. Neuropsychological Measures (RBANS) [ Time Frame: Week 17 ]
    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  7. Neuropsychological Measures (BDI II) [ Time Frame: Week 0 ]
    Beck Depression Inventory II (BDI II)

  8. Neuropsychological Measures (BDI II) [ Time Frame: Week 9 ]
    Beck Depression Inventory II (BDI II)

  9. Neuropsychological Measures (BDI II) [ Time Frame: Week 17 ]
    Beck Depression Inventory II (BDI II)

  10. Neuropsychological Measures (MoCA) [ Time Frame: Week 0 ]
    Montreal Cognitive Assessment (MoCA)

  11. Neuropsychological Measures (MoCA) [ Time Frame: Week 9 ]
    Montreal Cognitive Assessment (MoCA)

  12. Neuropsychological Measures (MoCA) [ Time Frame: Week 17 ]
    Montreal Cognitive Assessment (MoCA)

  13. Patient-Rate Questionnaires (FSS) [ Time Frame: Week 0 ]
    Fatigue Severity Scale (FSS)

  14. Patient-Rate Questionnaires (FSS) [ Time Frame: Week 5 ]
    Fatigue Severity Scale (FSS)

  15. Patient-Rate Questionnaires (FSS) [ Time Frame: Week 9 ]
    Fatigue Severity Scale (FSS)

  16. Patient-Rate Questionnaires (FSS) [ Time Frame: Week 14 ]
    Fatigue Severity Scale (FSS)

  17. Patient-Rate Questionnaires (FSS) [ Time Frame: Week 17 ]
    Fatigue Severity Scale (FSS)

  18. Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 0 ]
    Migraine Disability Assessment (MIDAS)

  19. Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 5 ]
    Migraine Disability Assessment (MIDAS)

  20. Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 9 ]
    Migraine Disability Assessment (MIDAS)

  21. Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 14 ]
    Migraine Disability Assessment (MIDAS)

  22. Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 17 ]
    Migraine Disability Assessment (MIDAS)

  23. Patient-Rate Questionnaires (HIT) [ Time Frame: Week 0 ]
    Headache Impact Scale (HIT)

  24. Patient-Rate Questionnaires (HIT) [ Time Frame: Week 5 ]
    Headache Impact Scale (HIT)

  25. Patient-Rate Questionnaires (HIT) [ Time Frame: Week 9 ]
    Headache Impact Scale (HIT)

  26. Patient-Rate Questionnaires (HIT) [ Time Frame: Week 14 ]
    Headache Impact Scale (HIT)

  27. Patient-Rate Questionnaires (HIT) [ Time Frame: Week 17 ]
    Headache Impact Scale (HIT)

  28. Patient-Rate Questionnaires (Activities) [ Time Frame: Week 0 ]
    Activities of Daily Living Sliding Scale and Questionnaire

  29. Patient-Rate Questionnaires (Activities) [ Time Frame: Week 5 ]
    Activities of Daily Living Sliding Scale and Questionnaire

  30. Patient-Rate Questionnaires (Activities) [ Time Frame: Week 9 ]
    Activities of Daily Living Sliding Scale and Questionnaire

  31. Patient-Rate Questionnaires (Activities) [ Time Frame: Week 14 ]
    Activities of Daily Living Sliding Scale and Questionnaire

  32. Patient-Rate Questionnaires (Activities) [ Time Frame: Week 17 ]
    Activities of Daily Living Sliding Scale and Questionnaire

  33. Patient-Rate Questionnaires (SF) [ Time Frame: Week 0 ]
    SF McGill Pain Questionnaire

  34. Patient-Rate Questionnaires (SF) [ Time Frame: Week 5 ]
    SF McGill Pain Questionnaire

  35. Patient-Rate Questionnaires (SF) [ Time Frame: Week 9 ]
    SF McGill Pain Questionnaire

  36. Patient-Rate Questionnaires (SF) [ Time Frame: Week 14 ]
    SF McGill Pain Questionnaire

  37. Patient-Rate Questionnaires (SF) [ Time Frame: Week 17 ]
    SF McGill Pain Questionnaire

  38. Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 0 ]
    Gastrointestinal Symptoms Rating Scale (GSRS)

  39. Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 5 ]
    Gastrointestinal Symptoms Rating Scale (GSRS)

  40. Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 9 ]
    Gastrointestinal Symptoms Rating Scale (GSRS)

  41. Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 14 ]
    Gastrointestinal Symptoms Rating Scale (GSRS)

  42. Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 17 ]
    Gastrointestinal Symptoms Rating Scale (GSRS)

  43. Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 0 ]
    SF-36

  44. Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 5 ]
    SF-36

  45. Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 9 ]
    SF-36

  46. Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 14 ]
    SF-36

  47. Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 17 ]
    SF-36

  48. Neurological Exam (0) [ Time Frame: Week 0 ]
    Complete neurological examination

  49. Neurological Exam (9) [ Time Frame: Week 9 ]
    Complete neurological examination

  50. Neurological Exam (17) [ Time Frame: Week 17 ]
    Complete neurological examination

  51. Immunological Biomarkers (Toll) [ Time Frame: Week 1 ]
    Toll Like Receptor Function Assay

  52. Immunological Biomarkers (Toll) [ Time Frame: Week 9 ]
    Toll Like Receptor Function Assay

  53. Immunological Biomarkers (Toll) [ Time Frame: Week 17 ]
    Toll Like Receptor Function Assay

  54. Immunological Biomarkers (GAD) [ Time Frame: Week 1 ]
    GAD-65

  55. Immunological Biomarkers (GAD) [ Time Frame: Week 9 ]
    GAD-65

  56. Immunological Biomarkers (GAD) [ Time Frame: Week 17 ]
    GAD-65

  57. Immunological Biomarkers (Com) [ Time Frame: Week 1 ]
    Complement Panel (C4, C1-INH, C1-INH Function)

  58. Immunological Biomarkers (Com) [ Time Frame: Week 9 ]
    Complement Panel (C4, C1-INH, C1-INH Function)

  59. Immunological Biomarkers (Com) [ Time Frame: Week 17 ]
    Complement Panel (C4, C1-INH, C1-INH Function)

  60. Immunological Biomarkers (Ig) [ Time Frame: Week 1 ]
    Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)

  61. Immunological Biomarkers (Ig) [ Time Frame: Week 9 ]
    Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)

  62. Immunological Biomarkers (Ig) [ Time Frame: Week 17 ]
    Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)

  63. Immunological Biomarkers (IgG) [ Time Frame: Week 1 ]
    Immunoglobulins G, Subclasses (1-4)

  64. Immunological Biomarkers (IgG) [ Time Frame: Week 9 ]
    Immunoglobulins G, Subclasses (1-4)

  65. Immunological Biomarkers (IgG) [ Time Frame: Week 17 ]
    Immunoglobulins G, Subclasses (1-4)

  66. Immunological Biomarkers (TH/TH) [ Time Frame: Week 1 ]
    TH1/TH2 Cytokine Levels

  67. Immunological Biomarkers (TH/TH) [ Time Frame: Week 9 ]
    TH1/TH2 Cytokine Levels

  68. Immunological Biomarkers (TH/TH) [ Time Frame: Week 17 ]
    TH1/TH2 Cytokine Levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705831


Contacts
Layout table for location contacts
Contact: Maureen Collins 303-771-9000 ext 1248 mcollins@immunoe.com
Contact: Alicia Palm 303-225-0087 apalm@immunoe.com

Locations
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United States, Colorado
IMMUNOe Research Centers Recruiting
Centennial, Colorado, United States, 80112
Contact: Maureen Collins    303-771-9000 ext 1248    mcollins@immunoe.com   
Principal Investigator: Isaac Melamed, MD         
Sponsors and Collaborators
IMMUNOe Research Centers
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Responsible Party: Isaac Melamed, MD, Principal Investigator, IMMUNOe Research Centers
ClinicalTrials.gov Identifier: NCT04705831    
Other Study ID Numbers: IIS202001-Neuroimmune
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Isaac Melamed, MD, IMMUNOe Research Centers:
Post-COVID Symptoms
Post-Viral Fatigue Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Fatigue
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Complement C1 Inhibitor Protein
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs