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Completed

NCT Number: NCT04705831

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

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.

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Key information

Conditions

Post-Viral Fatigue Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Covid19 Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Infections Lung Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Viral Disorder (Disorder) RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ruconest

Drug

C1 Esterase Inhibitor

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

IMMUNOe Research Centers

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2021
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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