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

August 5, 2025 updated by: Isaac Melamed, MD, IMMUNOe Research Centers

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Centennial, Colorado, United States, 80112
        • IMMUNOe Research Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Ruconest
C1 Esterase Inhibitor
Active Comparator: RUCONEST
IV Ruconest
Drug: Ruconest
C1 Esterase Inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 0
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Week 0
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 9
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Week 9
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 17
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Week 17
Neuropsychological Measures (RBANS)
Time Frame: Week 0
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Week 0
Neuropsychological Measures (RBANS)
Time Frame: Week 9
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Week 9
Neuropsychological Measures (RBANS)
Time Frame: Week 17
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Week 17
Neuropsychological Measures (BDI II)
Time Frame: Week 0
Beck Depression Inventory II (BDI II)
Week 0
Neuropsychological Measures (BDI II)
Time Frame: Week 9
Beck Depression Inventory II (BDI II)
Week 9
Neuropsychological Measures (BDI II)
Time Frame: Week 17
Beck Depression Inventory II (BDI II)
Week 17
Neuropsychological Measures (MoCA)
Time Frame: Week 0
Montreal Cognitive Assessment (MoCA)
Week 0
Neuropsychological Measures (MoCA)
Time Frame: Week 9
Montreal Cognitive Assessment (MoCA)
Week 9
Neuropsychological Measures (MoCA)
Time Frame: Week 17
Montreal Cognitive Assessment (MoCA)
Week 17
Patient-Rate Questionnaires (FSS)
Time Frame: Week 0
Fatigue Severity Scale (FSS)
Week 0
Patient-Rate Questionnaires (FSS)
Time Frame: Week 5
Fatigue Severity Scale (FSS)
Week 5
Patient-Rate Questionnaires (FSS)
Time Frame: Week 9
Fatigue Severity Scale (FSS)
Week 9
Patient-Rate Questionnaires (FSS)
Time Frame: Week 14
Fatigue Severity Scale (FSS)
Week 14
Patient-Rate Questionnaires (FSS)
Time Frame: Week 17
Fatigue Severity Scale (FSS)
Week 17
Patient-Rate Questionnaires (MIDAS)
Time Frame: Week 0
Migraine Disability Assessment (MIDAS)
Week 0
Patient-Rate Questionnaires (MIDAS)
Time Frame: Week 5
Migraine Disability Assessment (MIDAS)
Week 5
Patient-Rate Questionnaires (MIDAS)
Time Frame: Week 9
Migraine Disability Assessment (MIDAS)
Week 9
Patient-Rate Questionnaires (MIDAS)
Time Frame: Week 14
Migraine Disability Assessment (MIDAS)
Week 14
Patient-Rate Questionnaires (MIDAS)
Time Frame: Week 17
Migraine Disability Assessment (MIDAS)
Week 17
Patient-Rate Questionnaires (HIT)
Time Frame: Week 0
Headache Impact Scale (HIT)
Week 0
Patient-Rate Questionnaires (HIT)
Time Frame: Week 5
Headache Impact Scale (HIT)
Week 5
Patient-Rate Questionnaires (HIT)
Time Frame: Week 9
Headache Impact Scale (HIT)
Week 9
Patient-Rate Questionnaires (HIT)
Time Frame: Week 14
Headache Impact Scale (HIT)
Week 14
Patient-Rate Questionnaires (HIT)
Time Frame: Week 17
Headache Impact Scale (HIT)
Week 17
Patient-Rate Questionnaires (Activities)
Time Frame: Week 0
Activities of Daily Living Sliding Scale and Questionnaire
Week 0
Patient-Rate Questionnaires (Activities)
Time Frame: Week 5
Activities of Daily Living Sliding Scale and Questionnaire
Week 5
Patient-Rate Questionnaires (Activities)
Time Frame: Week 9
Activities of Daily Living Sliding Scale and Questionnaire
Week 9
Patient-Rate Questionnaires (Activities)
Time Frame: Week 14
Activities of Daily Living Sliding Scale and Questionnaire
Week 14
Patient-Rate Questionnaires (Activities)
Time Frame: Week 17
Activities of Daily Living Sliding Scale and Questionnaire
Week 17
Patient-Rate Questionnaires (SF)
Time Frame: Week 0
SF McGill Pain Questionnaire
Week 0
Patient-Rate Questionnaires (SF)
Time Frame: Week 5
SF McGill Pain Questionnaire
Week 5
Patient-Rate Questionnaires (SF)
Time Frame: Week 9
SF McGill Pain Questionnaire
Week 9
Patient-Rate Questionnaires (SF)
Time Frame: Week 14
SF McGill Pain Questionnaire
Week 14
Patient-Rate Questionnaires (SF)
Time Frame: Week 17
SF McGill Pain Questionnaire
Week 17
Patient-Rate Questionnaires (GSRS)
Time Frame: Week 0
Gastrointestinal Symptoms Rating Scale (GSRS)
Week 0
Patient-Rate Questionnaires (GSRS)
Time Frame: Week 5
Gastrointestinal Symptoms Rating Scale (GSRS)
Week 5
Patient-Rate Questionnaires (GSRS)
Time Frame: Week 9
Gastrointestinal Symptoms Rating Scale (GSRS)
Week 9
Patient-Rate Questionnaires (GSRS)
Time Frame: Week 14
Gastrointestinal Symptoms Rating Scale (GSRS)
Week 14
Patient-Rate Questionnaires (GSRS)
Time Frame: Week 17
Gastrointestinal Symptoms Rating Scale (GSRS)
Week 17
Patient-Rate Questionnaires (SF-36)
Time Frame: Week 0
SF-36
Week 0
Patient-Rate Questionnaires (SF-36)
Time Frame: Week 5
SF-36
Week 5
Patient-Rate Questionnaires (SF-36)
Time Frame: Week 9
SF-36
Week 9
Patient-Rate Questionnaires (SF-36)
Time Frame: Week 14
SF-36
Week 14
Patient-Rate Questionnaires (SF-36)
Time Frame: Week 17
SF-36
Week 17
Neurological Exam (0)
Time Frame: Week 0
Complete neurological examination
Week 0
Neurological Exam (9)
Time Frame: Week 9
Complete neurological examination
Week 9
Neurological Exam (17)
Time Frame: Week 17
Complete neurological examination
Week 17
Immunological Biomarkers (Toll)
Time Frame: Week 1
Toll Like Receptor Function Assay
Week 1
Immunological Biomarkers (Toll)
Time Frame: Week 9
Toll Like Receptor Function Assay
Week 9
Immunological Biomarkers (Toll)
Time Frame: Week 17
Toll Like Receptor Function Assay
Week 17
Immunological Biomarkers (GAD)
Time Frame: Week 1
GAD-65
Week 1
Immunological Biomarkers (GAD)
Time Frame: Week 9
GAD-65
Week 9
Immunological Biomarkers (GAD)
Time Frame: Week 17
GAD-65
Week 17
Immunological Biomarkers (Com)
Time Frame: Week 1
Complement Panel (C4, C1-INH, C1-INH Function)
Week 1
Immunological Biomarkers (Com)
Time Frame: Week 9
Complement Panel (C4, C1-INH, C1-INH Function)
Week 9
Immunological Biomarkers (Com)
Time Frame: Week 17
Complement Panel (C4, C1-INH, C1-INH Function)
Week 17
Immunological Biomarkers (Ig)
Time Frame: Week 1
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Week 1
Immunological Biomarkers (Ig)
Time Frame: Week 9
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Week 9
Immunological Biomarkers (Ig)
Time Frame: Week 17
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Week 17
Immunological Biomarkers (IgG)
Time Frame: Week 1
Immunoglobulins G, Subclasses (1-4)
Week 1
Immunological Biomarkers (IgG)
Time Frame: Week 9
Immunoglobulins G, Subclasses (1-4)
Week 9
Immunological Biomarkers (IgG)
Time Frame: Week 17
Immunoglobulins G, Subclasses (1-4)
Week 17
Immunological Biomarkers (TH/TH)
Time Frame: Week 1
TH1/TH2 Cytokine Levels
Week 1
Immunological Biomarkers (TH/TH)
Time Frame: Week 9
TH1/TH2 Cytokine Levels
Week 9
Immunological Biomarkers (TH/TH)
Time Frame: Week 17
TH1/TH2 Cytokine Levels
Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IMMUNOe Research Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIS202001-Neuroimmune

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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