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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neuropsychological Measures (MoCA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
RUCONEST
IV Ruconest
干预措施: Ruconest (Drug)
Placebo
Placebo
干预措施: Ruconest (Drug)
结局指标
主要结局
Neuropsychological Measures (MoCA)
时间窗: Week 17
Montreal Cognitive Assessment (MoCA)
Patient-Rate Questionnaires (GSRS)
时间窗: Week 17
Gastrointestinal Symptoms Rating Scale (GSRS)
Patient-Rate Questionnaires (SF-36)
时间窗: Week 17
SF-36
Neurological Exam (17)
时间窗: Week 17
Complete neurological examination
Neuropsychological Measures (BRIEF-A)
时间窗: Week 17
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Patient-Rate Questionnaires (FSS)
时间窗: Week 17
Fatigue Severity Scale (FSS)
Immunological Biomarkers (Toll)
时间窗: Week 17
Toll Like Receptor Function Assay
Immunological Biomarkers (GAD)
时间窗: Week 17
GAD-65
Immunological Biomarkers (Com)
时间窗: Week 17
Complement Panel (C4, C1-INH, C1-INH Function)
Immunological Biomarkers (Ig)
时间窗: Week 17
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Neuropsychological Measures (RBANS)
时间窗: Week 17
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Neuropsychological Measures (BDI II)
时间窗: Week 17
Beck Depression Inventory II (BDI II)
Immunological Biomarkers (IgG)
时间窗: Week 17
Immunoglobulins G, Subclasses (1-4)
Immunological Biomarkers (TH/TH)
时间窗: Week 17
TH1/TH2 Cytokine Levels
Patient-Rate Questionnaires (HIT)
时间窗: Week 17
Headache Impact Scale (HIT)
Patient-Rate Questionnaires (SF)
时间窗: Week 17
SF McGill Pain Questionnaire
Neurological Exam (0)
时间窗: Week 0
Complete neurological examination
Neurological Exam (9)
时间窗: Week 9
Complete neurological examination
Patient-Rate Questionnaires (MIDAS)
时间窗: Week 17
Migraine Disability Assessment (MIDAS)
Patient-Rate Questionnaires (Activities)
时间窗: Week 17
Activities of Daily Living Sliding Scale and Questionnaire
次要结局
未报告次要终点
研究者
Isaac Melamed, MD
Principal Investigator
IMMUNOe Research Centers