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

2026年11月6日 更新者：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

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Colorado
      • Centennial、Colorado、美国、80112
        • 招聘中
        • IMMUNOe Research Centers
        • 接触：
        • 首席研究员：
          • Isaac Melamed, MD
        • 副研究员：
          • J. Lynn Williams, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Ruconest

IV Ruconest
药品：Ruconest

IV Ruconest

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Neuropsychological Measures (BRIEF-A)
大体时间：Week 0

Behavior Rating Inventory of Executive Function - Adult
Week 0
Neuropsychological Measures (BRIEF-A)
大体时间：Week 5

Behavior Rating Inventory of Executive Function - Adult
Week 5
Neuropsychological Measures (BRIEF-A)
大体时间：Week 9

Behavior Rating Inventory of Executive Function - Adult
Week 9
Neuropsychological Measures (BRIEF-A)
大体时间：Week 13

Behavior Rating Inventory of Executive Function - Adult
Week 13
Neuropsychological Measures (BRIEF-A)
大体时间：Week 17

Behavior Rating Inventory of Executive Function - Adult
Week 17
Neuropsychological Measures (BRIEF-A)
大体时间：Week 21

Behavior Rating Inventory of Executive Function - Adult
Week 21
Neuropsychological Measures (BRIEF-A)
大体时间：Week 25

Behavior Rating Inventory of Executive Function - Adult
Week 25
Neuropsychological Measures (RBANS)
大体时间：Week 0

Repeatable Battery for the Assessment of Neuropsychological Status
Week 0
Neuropsychological Measures (RBANS)
大体时间：Week 5

Repeatable Battery for the Assessment of Neuropsychological Status
Week 5
Neuropsychological Measures (RBANS)
大体时间：Week 9

Repeatable Battery for the Assessment of Neuropsychological Status
Week 9
Neuropsychological Measures (RBANS)
大体时间：Week 13

Repeatable Battery for the Assessment of Neuropsychological Status
Week 13
Neuropsychological Measures (RBANS)
大体时间：Week 17

Repeatable Battery for the Assessment of Neuropsychological Status
Week 17
Neuropsychological Measures (RBANS)
大体时间：Week 21

Repeatable Battery for the Assessment of Neuropsychological Status
Week 21
Neuropsychological Measures (RBANS)
大体时间：Week 25

Repeatable Battery for the Assessment of Neuropsychological Status
Week 25
Neuropsychological Measures (BDI II)
大体时间：Week 0

Beck Depression Inventory (BDI II)
Week 0
Neuropsychological Measures (BDI II)
大体时间：Week 5

Beck Depression Inventory (BDI II)
Week 5
Neuropsychological Measures (BDI II)
大体时间：Week 9

Beck Depression Inventory (BDI II)
Week 9
Neuropsychological Measures (BDI II)
大体时间：Week 13

Beck Depression Inventory (BDI II)
Week 13
Neuropsychological Measures (BDI II)
大体时间：Week 17

Beck Depression Inventory (BDI II)
Week 17
Neuropsychological Measures (BDI II)
大体时间：Week 21

Beck Depression Inventory (BDI II)
Week 21
Neuropsychological Measures (BDI II)
大体时间：Week 25

Beck Depression Inventory (BDI II)
Week 25
Neuropsychological Measures (MoCA)
大体时间：Week 0

Montreal Cognitive Assessment (MoCA)
Week 0
Neuropsychological Measures (MoCA)
大体时间：Week 5

Montreal Cognitive Assessment (MoCA)
Week 5
Neuropsychological Measures (MoCA)
大体时间：Week 9

Montreal Cognitive Assessment (MoCA)
Week 9
Neuropsychological Measures (MoCA)
大体时间：Week 13

Montreal Cognitive Assessment (MoCA)
Week 13
Neuropsychological Measures (MoCA)
大体时间：Week 17

Montreal Cognitive Assessment (MoCA)
Week 17
Neuropsychological Measures (MoCA)
大体时间：Week 21

Montreal Cognitive Assessment (MoCA)
Week 21
Neuropsychological Measures (MoCA)
大体时间：Week 25

Montreal Cognitive Assessment (MoCA)
Week 25
Patient-Rated Questionnaire (FSS)
大体时间：Week 0

Fatigue Severity Scale (FSS)
Week 0
Patient-Rated Questionnaire (FSS)
大体时间：Week 5

Fatigue Severity Scale (FSS)
Week 5
Patient-Rated Questionnaire (FSS)
大体时间：Week 9

Fatigue Severity Scale (FSS)
Week 9
Patient-Rated Questionnaire (FSS)
大体时间：Week 13

Fatigue Severity Scale (FSS)
Week 13
Patient-Rated Questionnaire (FSS)
大体时间：Week 17

Fatigue Severity Scale (FSS)
Week 17
Patient-Rated Questionnaire (FSS)
大体时间：Week 21

Fatigue Severity Scale (FSS)
Week 21
Patient-Rated Questionnaire (FSS)
大体时间：Week 25

Fatigue Severity Scale (FSS)
Week 25
Patient-Rated Questionnaire (MIDAS)
大体时间：Week 0

Migraine Disability Assessment (MIDAS)
Week 0
Patient-Rated Questionnaire (MIDAS)
大体时间：Week 5

Migraine Disability Assessment (MIDAS)
Week 5
Patient-Rated Questionnaire (MIDAS)
大体时间：Week 9

Migraine Disability Assessment (MIDAS)
Week 9
Patient-Rated Questionnaire (MIDAS)
大体时间：Week 13

Migraine Disability Assessment (MIDAS)
Week 13
Patient-Rated Questionnaire (MIDAS)
大体时间：Week 17

Migraine Disability Assessment (MIDAS)
Week 17
Patient-Rated Questionnaire (MIDAS)
大体时间：Week 21

Migraine Disability Assessment (MIDAS)
Week 21
Patient-Rated Questionnaire (MIDAS)
大体时间：Week 25

Migraine Disability Assessment (MIDAS)
Week 25
Patient-Rated Questionnaire (HIT)
大体时间：Week 0

Headache Impact Scale (HIT)
Week 0
Patient-Rated Questionnaire (HIT)
大体时间：Week 5

Headache Impact Scale (HIT)
Week 5
Patient-Rated Questionnaire (HIT)
大体时间：Week 9

Headache Impact Scale (HIT)
Week 9
Patient-Rated Questionnaire (HIT)
大体时间：Week 13

Headache Impact Scale (HIT)
Week 13
Patient-Rated Questionnaire (HIT)
大体时间：Week 17

Headache Impact Scale (HIT)
Week 17
Patient-Rated Questionnaire (HIT)
大体时间：Week 21

Headache Impact Scale (HIT)
Week 21
Patient-Rated Questionnaire (HIT)
大体时间：Week 25

Headache Impact Scale (HIT)
Week 25
Patient-Rated Questionnaire (Activities)
大体时间：Week 0

Activities of Daily Living Sliding Scale and Questionnaire
Week 0
Patient-Rated Questionnaire (Activities)
大体时间：Week 5

Activities of Daily Living Sliding Scale and Questionnaire
Week 5
Patient-Rated Questionnaire (Activities)
大体时间：Week 9

Activities of Daily Living Sliding Scale and Questionnaire
Week 9
Patient-Rated Questionnaire (Activities)
大体时间：Week 13

Activities of Daily Living Sliding Scale and Questionnaire
Week 13
Patient-Rated Questionnaire (Activities)
大体时间：Week 17

Activities of Daily Living Sliding Scale and Questionnaire
Week 17
Patient-Rated Questionnaire (Activities)
大体时间：Week 21

Activities of Daily Living Sliding Scale and Questionnaire
Week 21
Patient-Rated Questionnaire (Activities)
大体时间：Week 25

Activities of Daily Living Sliding Scale and Questionnaire
Week 25
Patient-Rated Questionnaire (SF)
大体时间：Week 0

SF McGill Pain Questionnaire
Week 0
Patient-Rated Questionnaire (SF)
大体时间：Week 5

SF McGill Pain Questionnaire
Week 5
Patient-Rated Questionnaire (SF)
大体时间：Week 9

SF McGill Pain Questionnaire
Week 9
Patient-Rated Questionnaire (SF)
大体时间：Week 13

SF McGill Pain Questionnaire
Week 13
Patient-Rated Questionnaire (SF)
大体时间：Week 17

SF McGill Pain Questionnaire
Week 17
Patient-Rated Questionnaire (SF)
大体时间：Week 21

SF McGill Pain Questionnaire
Week 21
Patient-Rated Questionnaire (SF)
大体时间：Week 25

SF McGill Pain Questionnaire
Week 25
Patient-Rated Questionnaire (GSRS)
大体时间：Week 0

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 0
Patient-Rated Questionnaire (GSRS)
大体时间：Week 5

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 5
Patient-Rated Questionnaire (GSRS)
大体时间：Week 9

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 9
Patient-Rated Questionnaire (GSRS)
大体时间：Week 13

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 13
Patient-Rated Questionnaire (GSRS)
大体时间：Week 17

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 17
Patient-Rated Questionnaire (GSRS)
大体时间：Week 21

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 21
Patient-Rated Questionnaire (GSRS)
大体时间：Week 25

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 25
Patient-Rated Questionnaire (SF-36)
大体时间：Week 0

SF-36
Week 0
Patient-Rated Questionnaire (SF-36)
大体时间：Week 5

SF-36
Week 5
Patient-Rated Questionnaire (SF-36)
大体时间：Week 9

SF-36
Week 9
Patient-Rated Questionnaire (SF-36)
大体时间：Week 13

SF-36
Week 13
Patient-Rated Questionnaire (SF-36)
大体时间：Week 17

SF-36
Week 17
Patient-Rated Questionnaire (SF-36)
大体时间：Week 21

SF-36
Week 21
Patient-Rated Questionnaire (SF-36)
大体时间：Week 25

SF-36
Week 25
Neurological Exam
大体时间：Week 0

Complete neurological examination
Week 0
Neurological Exam
大体时间：Week 5

Complete neurological examination
Week 5
Neurological Exam
大体时间：Week 9

Complete neurological examination
Week 9
Neurological Exam
大体时间：Week 13

Complete neurological examination
Week 13
Neurological Exam
大体时间：Week 17

Complete neurological examination
Week 17
Neurological Exam
大体时间：Week 21

Complete neurological examination
Week 21
Neurological Exam
大体时间：Week 25

Complete neurological examination
Week 25

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

IMMUNOe Research Centers

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月5日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2027年10月29日

研究注册日期

首次提交

2026年11月6日

首先提交符合 QC 标准的

2026年11月6日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IIS202402

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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