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

Phase 4

• Conditions: Post-Viral Fatigue Syndrome; Post-Viral Disorder (Disorder); Covid19
• Interventions: Drug: Ruconest

• Registration Number: NCT04705831
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RUCONEST	Ruconest	IV Ruconest
Placebo	Ruconest	Placebo

Primary Outcome Measures

Name	Time	Method
Patient-Rate Questionnaires (GSRS)	Week 17	Gastrointestinal Symptoms Rating Scale (GSRS)
Patient-Rate Questionnaires (SF-36)	Week 17	SF-36
Neurological Exam (17)	Week 17	Complete neurological examination
Neuropsychological Measures (BRIEF-A)	Week 17	Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Patient-Rate Questionnaires (FSS)	Week 17	Fatigue Severity Scale (FSS)
Immunological Biomarkers (Toll)	Week 17	Toll Like Receptor Function Assay
Immunological Biomarkers (GAD)	Week 17	GAD-65
Immunological Biomarkers (Com)	Week 17	Complement Panel (C4, C1-INH, C1-INH Function)
Immunological Biomarkers (Ig)	Week 17	Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Neuropsychological Measures (RBANS)	Week 17	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Neuropsychological Measures (BDI II)	Week 17	Beck Depression Inventory II (BDI II)
Immunological Biomarkers (IgG)	Week 17	Immunoglobulins G, Subclasses (1-4)
Immunological Biomarkers (TH/TH)	Week 17	TH1/TH2 Cytokine Levels
Patient-Rate Questionnaires (HIT)	Week 17	Headache Impact Scale (HIT)
Patient-Rate Questionnaires (SF)	Week 17	SF McGill Pain Questionnaire
Neurological Exam (0)	Week 0	Complete neurological examination
Neurological Exam (9)	Week 9	Complete neurological examination
Neuropsychological Measures (MoCA)	Week 17	Montreal Cognitive Assessment (MoCA)
Patient-Rate Questionnaires (MIDAS)	Week 17	Migraine Disability Assessment (MIDAS)
Patient-Rate Questionnaires (Activities)	Week 17	Activities of Daily Living Sliding Scale and Questionnaire

Trial Locations

Locations (1)

IMMUNOe Research Centers; 🇺🇸 Centennial, Colorado, United States