Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
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ClinicalTrials.gov Identifier: NCT04705831 |
Recruitment Status : Unknown
Verified January 2021 by Isaac Melamed, MD, IMMUNOe Research Centers.
Recruitment status was: Recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post-Viral Fatigue Syndrome Post-Viral Disorder (Disorder) Covid19 | Drug: Ruconest | Phase 4 |
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 |
- Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 0 ]Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
- Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 9 ]Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
- Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 17 ]Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
- Neuropsychological Measures (RBANS) [ Time Frame: Week 0 ]Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Neuropsychological Measures (RBANS) [ Time Frame: Week 9 ]Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Neuropsychological Measures (RBANS) [ Time Frame: Week 17 ]Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Neuropsychological Measures (BDI II) [ Time Frame: Week 0 ]Beck Depression Inventory II (BDI II)
- Neuropsychological Measures (BDI II) [ Time Frame: Week 9 ]Beck Depression Inventory II (BDI II)
- Neuropsychological Measures (BDI II) [ Time Frame: Week 17 ]Beck Depression Inventory II (BDI II)
- Neuropsychological Measures (MoCA) [ Time Frame: Week 0 ]Montreal Cognitive Assessment (MoCA)
- Neuropsychological Measures (MoCA) [ Time Frame: Week 9 ]Montreal Cognitive Assessment (MoCA)
- Neuropsychological Measures (MoCA) [ Time Frame: Week 17 ]Montreal Cognitive Assessment (MoCA)
- Patient-Rate Questionnaires (FSS) [ Time Frame: Week 0 ]Fatigue Severity Scale (FSS)
- Patient-Rate Questionnaires (FSS) [ Time Frame: Week 5 ]Fatigue Severity Scale (FSS)
- Patient-Rate Questionnaires (FSS) [ Time Frame: Week 9 ]Fatigue Severity Scale (FSS)
- Patient-Rate Questionnaires (FSS) [ Time Frame: Week 14 ]Fatigue Severity Scale (FSS)
- Patient-Rate Questionnaires (FSS) [ Time Frame: Week 17 ]Fatigue Severity Scale (FSS)
- Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 0 ]Migraine Disability Assessment (MIDAS)
- Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 5 ]Migraine Disability Assessment (MIDAS)
- Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 9 ]Migraine Disability Assessment (MIDAS)
- Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 14 ]Migraine Disability Assessment (MIDAS)
- Patient-Rate Questionnaires (MIDAS) [ Time Frame: Week 17 ]Migraine Disability Assessment (MIDAS)
- Patient-Rate Questionnaires (HIT) [ Time Frame: Week 0 ]Headache Impact Scale (HIT)
- Patient-Rate Questionnaires (HIT) [ Time Frame: Week 5 ]Headache Impact Scale (HIT)
- Patient-Rate Questionnaires (HIT) [ Time Frame: Week 9 ]Headache Impact Scale (HIT)
- Patient-Rate Questionnaires (HIT) [ Time Frame: Week 14 ]Headache Impact Scale (HIT)
- Patient-Rate Questionnaires (HIT) [ Time Frame: Week 17 ]Headache Impact Scale (HIT)
- Patient-Rate Questionnaires (Activities) [ Time Frame: Week 0 ]Activities of Daily Living Sliding Scale and Questionnaire
- Patient-Rate Questionnaires (Activities) [ Time Frame: Week 5 ]Activities of Daily Living Sliding Scale and Questionnaire
- Patient-Rate Questionnaires (Activities) [ Time Frame: Week 9 ]Activities of Daily Living Sliding Scale and Questionnaire
- Patient-Rate Questionnaires (Activities) [ Time Frame: Week 14 ]Activities of Daily Living Sliding Scale and Questionnaire
- Patient-Rate Questionnaires (Activities) [ Time Frame: Week 17 ]Activities of Daily Living Sliding Scale and Questionnaire
- Patient-Rate Questionnaires (SF) [ Time Frame: Week 0 ]SF McGill Pain Questionnaire
- Patient-Rate Questionnaires (SF) [ Time Frame: Week 5 ]SF McGill Pain Questionnaire
- Patient-Rate Questionnaires (SF) [ Time Frame: Week 9 ]SF McGill Pain Questionnaire
- Patient-Rate Questionnaires (SF) [ Time Frame: Week 14 ]SF McGill Pain Questionnaire
- Patient-Rate Questionnaires (SF) [ Time Frame: Week 17 ]SF McGill Pain Questionnaire
- Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 0 ]Gastrointestinal Symptoms Rating Scale (GSRS)
- Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 5 ]Gastrointestinal Symptoms Rating Scale (GSRS)
- Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 9 ]Gastrointestinal Symptoms Rating Scale (GSRS)
- Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 14 ]Gastrointestinal Symptoms Rating Scale (GSRS)
- Patient-Rate Questionnaires (GSRS) [ Time Frame: Week 17 ]Gastrointestinal Symptoms Rating Scale (GSRS)
- Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 0 ]SF-36
- Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 5 ]SF-36
- Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 9 ]SF-36
- Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 14 ]SF-36
- Patient-Rate Questionnaires (SF-36) [ Time Frame: Week 17 ]SF-36
- Neurological Exam (0) [ Time Frame: Week 0 ]Complete neurological examination
- Neurological Exam (9) [ Time Frame: Week 9 ]Complete neurological examination
- Neurological Exam (17) [ Time Frame: Week 17 ]Complete neurological examination
- Immunological Biomarkers (Toll) [ Time Frame: Week 1 ]Toll Like Receptor Function Assay
- Immunological Biomarkers (Toll) [ Time Frame: Week 9 ]Toll Like Receptor Function Assay
- Immunological Biomarkers (Toll) [ Time Frame: Week 17 ]Toll Like Receptor Function Assay
- Immunological Biomarkers (GAD) [ Time Frame: Week 1 ]GAD-65
- Immunological Biomarkers (GAD) [ Time Frame: Week 9 ]GAD-65
- Immunological Biomarkers (GAD) [ Time Frame: Week 17 ]GAD-65
- Immunological Biomarkers (Com) [ Time Frame: Week 1 ]Complement Panel (C4, C1-INH, C1-INH Function)
- Immunological Biomarkers (Com) [ Time Frame: Week 9 ]Complement Panel (C4, C1-INH, C1-INH Function)
- Immunological Biomarkers (Com) [ Time Frame: Week 17 ]Complement Panel (C4, C1-INH, C1-INH Function)
- Immunological Biomarkers (Ig) [ Time Frame: Week 1 ]Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
- Immunological Biomarkers (Ig) [ Time Frame: Week 9 ]Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
- Immunological Biomarkers (Ig) [ Time Frame: Week 17 ]Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
- Immunological Biomarkers (IgG) [ Time Frame: Week 1 ]Immunoglobulins G, Subclasses (1-4)
- Immunological Biomarkers (IgG) [ Time Frame: Week 9 ]Immunoglobulins G, Subclasses (1-4)
- Immunological Biomarkers (IgG) [ Time Frame: Week 17 ]Immunoglobulins G, Subclasses (1-4)
- Immunological Biomarkers (TH/TH) [ Time Frame: Week 1 ]TH1/TH2 Cytokine Levels
- Immunological Biomarkers (TH/TH) [ Time Frame: Week 9 ]TH1/TH2 Cytokine Levels
- Immunological Biomarkers (TH/TH) [ Time Frame: Week 17 ]TH1/TH2 Cytokine Levels

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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 |
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

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
Contact: Maureen Collins | 303-771-9000 ext 1248 | mcollins@immunoe.com | |
Contact: Alicia Palm | 303-225-0087 | apalm@immunoe.com |
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 |
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 |
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 |
Post-COVID Symptoms Post-Viral Fatigue Syndrome |
COVID-19 Fatigue Syndrome, Chronic Fatigue Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract 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 |