Exploring the Extended Efficacy and Initial Use of RUCONEST® in Managing Neurological Symptoms Linked to Infectious Pathogens

November 6, 2026 updated by: Isaac Melamed, MD, IMMUNOe Research Centers

Assessment of RUCONEST® (C1 Esterase Inhibitor [Recombinant]) in Alleviating Neurological Symptoms Linked to Infectious Pathogens

Assessment of RUCONEST (C1 Esterase Inhibitor [Recombinant]) in Alleviating Neurological Symptoms Linked to Infectious Pathogens

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will last approximately 30 weeks including 24 infusions total, each one week apart. This is an open label extension study aimed to investigate the continued use of RUCONEST in a post-SARS-CoV-2 population who experienced neurological symptoms both in patients who have participated in the previous trial (NCT04705831) as well as RUCONEST-naive participants.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Recruiting
        • IMMUNOe Research Centers
        • Contact:
        • Principal Investigator:
          • Isaac Melamed, MD
        • Sub-Investigator:
          • J. Lynn Williams, MD

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 and older, male or female
  • Patient is able to understand and fully participate in the activities of the study and the consent in accordance with federal regulations.
  • Patients who were involved in the previous study with defined post-COVID neurologic symptoms.
  • New patients who have been diagnosed with post-COVID neurologic symptoms.

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
  • Abnormal kidney or liver enzymes
  • History of thrombotic stroke
  • 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 within 30 days of study entry from any other clinical study involving and investigational product.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ruconest

IV Ruconest
Drug: Ruconest

IV Ruconest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 0

Behavior Rating Inventory of Executive Function - Adult
Week 0
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 5

Behavior Rating Inventory of Executive Function - Adult
Week 5
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 9

Behavior Rating Inventory of Executive Function - Adult
Week 9
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 13

Behavior Rating Inventory of Executive Function - Adult
Week 13
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 17

Behavior Rating Inventory of Executive Function - Adult
Week 17
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 21

Behavior Rating Inventory of Executive Function - Adult
Week 21
Neuropsychological Measures (BRIEF-A)
Time Frame: Week 25

Behavior Rating Inventory of Executive Function - Adult
Week 25
Neuropsychological Measures (RBANS)
Time Frame: Week 0

Repeatable Battery for the Assessment of Neuropsychological Status
Week 0
Neuropsychological Measures (RBANS)
Time Frame: Week 5

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

Repeatable Battery for the Assessment of Neuropsychological Status
Week 9
Neuropsychological Measures (RBANS)
Time Frame: Week 13

Repeatable Battery for the Assessment of Neuropsychological Status
Week 13
Neuropsychological Measures (RBANS)
Time Frame: Week 17

Repeatable Battery for the Assessment of Neuropsychological Status
Week 17
Neuropsychological Measures (RBANS)
Time Frame: Week 21

Repeatable Battery for the Assessment of Neuropsychological Status
Week 21
Neuropsychological Measures (RBANS)
Time Frame: Week 25

Repeatable Battery for the Assessment of Neuropsychological Status
Week 25
Neuropsychological Measures (BDI II)
Time Frame: Week 0

Beck Depression Inventory (BDI II)
Week 0
Neuropsychological Measures (BDI II)
Time Frame: Week 5

Beck Depression Inventory (BDI II)
Week 5
Neuropsychological Measures (BDI II)
Time Frame: Week 9

Beck Depression Inventory (BDI II)
Week 9
Neuropsychological Measures (BDI II)
Time Frame: Week 13

Beck Depression Inventory (BDI II)
Week 13
Neuropsychological Measures (BDI II)
Time Frame: Week 17

Beck Depression Inventory (BDI II)
Week 17
Neuropsychological Measures (BDI II)
Time Frame: Week 21

Beck Depression Inventory (BDI II)
Week 21
Neuropsychological Measures (BDI II)
Time Frame: Week 25

Beck Depression Inventory (BDI II)
Week 25
Neuropsychological Measures (MoCA)
Time Frame: Week 0

Montreal Cognitive Assessment (MoCA)
Week 0
Neuropsychological Measures (MoCA)
Time Frame: Week 5

Montreal Cognitive Assessment (MoCA)
Week 5
Neuropsychological Measures (MoCA)
Time Frame: Week 9

Montreal Cognitive Assessment (MoCA)
Week 9
Neuropsychological Measures (MoCA)
Time Frame: Week 13

Montreal Cognitive Assessment (MoCA)
Week 13
Neuropsychological Measures (MoCA)
Time Frame: Week 17

Montreal Cognitive Assessment (MoCA)
Week 17
Neuropsychological Measures (MoCA)
Time Frame: Week 21

Montreal Cognitive Assessment (MoCA)
Week 21
Neuropsychological Measures (MoCA)
Time Frame: Week 25

Montreal Cognitive Assessment (MoCA)
Week 25
Patient-Rated Questionnaire (FSS)
Time Frame: Week 0

Fatigue Severity Scale (FSS)
Week 0
Patient-Rated Questionnaire (FSS)
Time Frame: Week 5

Fatigue Severity Scale (FSS)
Week 5
Patient-Rated Questionnaire (FSS)
Time Frame: Week 9

Fatigue Severity Scale (FSS)
Week 9
Patient-Rated Questionnaire (FSS)
Time Frame: Week 13

Fatigue Severity Scale (FSS)
Week 13
Patient-Rated Questionnaire (FSS)
Time Frame: Week 17

Fatigue Severity Scale (FSS)
Week 17
Patient-Rated Questionnaire (FSS)
Time Frame: Week 21

Fatigue Severity Scale (FSS)
Week 21
Patient-Rated Questionnaire (FSS)
Time Frame: Week 25

Fatigue Severity Scale (FSS)
Week 25
Patient-Rated Questionnaire (MIDAS)
Time Frame: Week 0

Migraine Disability Assessment (MIDAS)
Week 0
Patient-Rated Questionnaire (MIDAS)
Time Frame: Week 5

Migraine Disability Assessment (MIDAS)
Week 5
Patient-Rated Questionnaire (MIDAS)
Time Frame: Week 9

Migraine Disability Assessment (MIDAS)
Week 9
Patient-Rated Questionnaire (MIDAS)
Time Frame: Week 13

Migraine Disability Assessment (MIDAS)
Week 13
Patient-Rated Questionnaire (MIDAS)
Time Frame: Week 17

Migraine Disability Assessment (MIDAS)
Week 17
Patient-Rated Questionnaire (MIDAS)
Time Frame: Week 21

Migraine Disability Assessment (MIDAS)
Week 21
Patient-Rated Questionnaire (MIDAS)
Time Frame: Week 25

Migraine Disability Assessment (MIDAS)
Week 25
Patient-Rated Questionnaire (HIT)
Time Frame: Week 0

Headache Impact Scale (HIT)
Week 0
Patient-Rated Questionnaire (HIT)
Time Frame: Week 5

Headache Impact Scale (HIT)
Week 5
Patient-Rated Questionnaire (HIT)
Time Frame: Week 9

Headache Impact Scale (HIT)
Week 9
Patient-Rated Questionnaire (HIT)
Time Frame: Week 13

Headache Impact Scale (HIT)
Week 13
Patient-Rated Questionnaire (HIT)
Time Frame: Week 17

Headache Impact Scale (HIT)
Week 17
Patient-Rated Questionnaire (HIT)
Time Frame: Week 21

Headache Impact Scale (HIT)
Week 21
Patient-Rated Questionnaire (HIT)
Time Frame: Week 25

Headache Impact Scale (HIT)
Week 25
Patient-Rated Questionnaire (Activities)
Time Frame: Week 0

Activities of Daily Living Sliding Scale and Questionnaire
Week 0
Patient-Rated Questionnaire (Activities)
Time Frame: Week 5

Activities of Daily Living Sliding Scale and Questionnaire
Week 5
Patient-Rated Questionnaire (Activities)
Time Frame: Week 9

Activities of Daily Living Sliding Scale and Questionnaire
Week 9
Patient-Rated Questionnaire (Activities)
Time Frame: Week 13

Activities of Daily Living Sliding Scale and Questionnaire
Week 13
Patient-Rated Questionnaire (Activities)
Time Frame: Week 17

Activities of Daily Living Sliding Scale and Questionnaire
Week 17
Patient-Rated Questionnaire (Activities)
Time Frame: Week 21

Activities of Daily Living Sliding Scale and Questionnaire
Week 21
Patient-Rated Questionnaire (Activities)
Time Frame: Week 25

Activities of Daily Living Sliding Scale and Questionnaire
Week 25
Patient-Rated Questionnaire (SF)
Time Frame: Week 0

SF McGill Pain Questionnaire
Week 0
Patient-Rated Questionnaire (SF)
Time Frame: Week 5

SF McGill Pain Questionnaire
Week 5
Patient-Rated Questionnaire (SF)
Time Frame: Week 9

SF McGill Pain Questionnaire
Week 9
Patient-Rated Questionnaire (SF)
Time Frame: Week 13

SF McGill Pain Questionnaire
Week 13
Patient-Rated Questionnaire (SF)
Time Frame: Week 17

SF McGill Pain Questionnaire
Week 17
Patient-Rated Questionnaire (SF)
Time Frame: Week 21

SF McGill Pain Questionnaire
Week 21
Patient-Rated Questionnaire (SF)
Time Frame: Week 25

SF McGill Pain Questionnaire
Week 25
Patient-Rated Questionnaire (GSRS)
Time Frame: Week 0

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 0
Patient-Rated Questionnaire (GSRS)
Time Frame: Week 5

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 5
Patient-Rated Questionnaire (GSRS)
Time Frame: Week 9

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 9
Patient-Rated Questionnaire (GSRS)
Time Frame: Week 13

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 13
Patient-Rated Questionnaire (GSRS)
Time Frame: Week 17

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 17
Patient-Rated Questionnaire (GSRS)
Time Frame: Week 21

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 21
Patient-Rated Questionnaire (GSRS)
Time Frame: Week 25

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 25
Patient-Rated Questionnaire (SF-36)
Time Frame: Week 0

SF-36
Week 0
Patient-Rated Questionnaire (SF-36)
Time Frame: Week 5

SF-36
Week 5
Patient-Rated Questionnaire (SF-36)
Time Frame: Week 9

SF-36
Week 9
Patient-Rated Questionnaire (SF-36)
Time Frame: Week 13

SF-36
Week 13
Patient-Rated Questionnaire (SF-36)
Time Frame: Week 17

SF-36
Week 17
Patient-Rated Questionnaire (SF-36)
Time Frame: Week 21

SF-36
Week 21
Patient-Rated Questionnaire (SF-36)
Time Frame: Week 25

SF-36
Week 25
Neurological Exam
Time Frame: Week 0

Complete neurological examination
Week 0
Neurological Exam
Time Frame: Week 5

Complete neurological examination
Week 5
Neurological Exam
Time Frame: Week 9

Complete neurological examination
Week 9
Neurological Exam
Time Frame: Week 13

Complete neurological examination
Week 13
Neurological Exam
Time Frame: Week 17

Complete neurological examination
Week 17
Neurological Exam
Time Frame: Week 21

Complete neurological examination
Week 21
Neurological Exam
Time Frame: Week 25

Complete neurological examination
Week 25

Collaborators and Investigators

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

Sponsor

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)

November 5, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 29, 2027

Study Registration Dates

First Submitted

November 6, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIS202402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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