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HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial (HORUS-COPE)

2026年4月29日 更新者：Oriol Manuel

HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial (HORUS-COPE): An International Proof-of-concept Clinical Trial on Modulation of Immunosuppressive Regimen in Solid-organ Transplant Recipients With Cytomegalovirus Infection.

Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.

Cell-mediated immunity plays a crucial role in controlling CMV replication after transplantation. Immune monitoring involves the use of immune biomarkers to dynamically estimate the risk of CMV replication. This approach allows for the individualization of preventive and therapeutic strategies, improving patient outcomes.

The HORUS-COPE trial is designed to assess the effect of immune modulation on CMV replication kinetics and to explore the performance of a selected immune signature during antiviral therapy for CMV infection to stratify patients based on their risk of not responding to immune modulation.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.

Cell-mediated immunity plays a crucial role in controlling CMV replication after transplantation. Immune monitoring involves the use of immune biomarkers-primarily those assessing cell-mediated immunity-to dynamically estimate the risk of CMV replication. This approach allows for the individualization of preventive and therapeutic strategies, improving patient outcomes.

The HORUS consortium is a comprehensive European research initiative aimed at providing an in-depth assessment of immune signatures associated with CMV immune control in SOT recipients. One of the ultimate goals of the HORUS project is to leverage these immune signatures to design and implement a clinical trial evaluating their feasibility and impact in routine clinical practice.

As part of this initiative, we introduce the HORUS-COPE trial, designed to assess the effect of immune modulation on CMV replication kinetics and to explore the performance of a selected immune signature during antiviral therapy for CMV infection to stratify patients based on their risk of not responding to immune modulation.

Specifically, immune modulation consists of either:

  1. a 50% dose reduction of an antimetabolite agent- mycophenolate mofetil [MMF, Cellcept®] or enteric-coated mycophenolate sodium [EC-MPS, Myfortic®]; hereafter referred to as mycophenolic acid [MPA])
  2. a switch from MPA to a mammalian target of rapamycin inhibitor (mTORi) everolimus, together with an adapted dose of tacrolimus.

研究类型

介入性

注册 (估计的)

100

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。

学习联系方式

  • 姓名：Oriol Manuel, Professor, MD
  • 电话号码：+41 79 556 61 36
  • 邮箱：oriol.manuel@chuv.ch

研究联系人备份

学习地点

  • 法国
    • Talence Cedex
      • Bourdeaux、Talence Cedex、法国、33404
        • Centre hospitalier universitaire Bordeaux (CHU Bordeaux)
        • 接触：
        • 副研究员：
          • Lionel Couzi, Professor MD, PhD
    • Toulouse
      • Toulouse、Toulouse、法国、31059
        • Centre hospitalier universitaire Toulouse (CHU Toulouse)
        • 接触：
  • 瑞士
    • Canton of Vaud
      • Lausanne、Canton of Vaud、瑞士、1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • 接触：
        • 接触：
        • 副研究员：
          • Dela Golshayan, Professor, MD PhD
        • 副研究员：
          • Julien Vionnet, MD, PhD
        • 副研究员：
          • Patrick Yerly, MD
  • 西班牙
    • Catalonia
      • Barcelona、Catalonia、西班牙、08035

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Clinically stable adult patients (aged 18 years or older) who have received a solid organ transplant (e.g., kidney, liver, heart, lung, pancreas) and developed clinically significant CMV infection as determined by positive CMV PCR.
  • On maintenance therapy of tacrolimus, MPA, +/- steroids.
  • Informed consent signed.

Exclusion Criteria:

  • Active acute graft rejection or significant graft dysfunction requiring modification of the current immunosuppressive regimen, in the opinion of the investigator.
  • Receipt of more than 72 hours of antiviral therapy for CMV infection prior to enrolment, before randomization, including valganciclovir and/or IV ganciclovir therapy
  • Known intolerance or hypersensitivity to mTOR inhibitors or to any component of the everolimus formulation.
  • Any medical condition that constitutes a contraindication to everolimus use, as judged by the investigator.

  • Additional exclusion criteria for French sites:

    • Patient not affiliated to the French social security system
    • Patient under legal protection (guardianship, curatorship).

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：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：50% reduction in the dose of MPA for a duration of minimum 21 days
with standard antiviral therapy
药品：50% reduction in the dose of MPA
50% reduction in the dose of MPA with standard antiviral therapy
其他名称：
  • 麦考酚酸
  • 霉酚酸酯
实验性的：switch of MPA to everolimus with adapted dose of tacrolimus, for a duration of at least 56 days
with standard antiviral therapy
药品：Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus
Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus, with standard antiviral therapy
其他名称：
  • 依维莫司
有源比较器：Standard antiviral therapy without modulation of immunosuppression
药品：standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.
standard antiviral therapy along with maintenance of their initial immunosuppressive therapy (control group)
其他名称：
  • 控制组

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
Viral load decay
大体时间：3 weeks
Differences in log CMV viral load in plasma between baseline and 3 weeks
3 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in CMV-specific immune signature score
大体时间：from enrollment to 3 and 8 weeks
Change in the CMV-specific immune signature from baseline to week 3 and week 8, assessed using a predefined composite immune monitoring panel derived from the HORUS cohort. The panel will include CMV-specific T-cell functional assays and phenotyping, such as quantitative and qualitative measures of CD4 and CD8 CMV-specific responses, cytokine production, and selected activation/exhaustion markers. Results will be summarized as change from baseline at each time point.
from enrollment to 3 and 8 weeks
Viral load decay according to immune signature
大体时间：3 and 8 weeks
Difference in log CMV viral load decay between baseline and 3 and 8 weeks according to baseline immune signature
3 and 8 weeks

其他结果措施

结果测量
措施说明
大体时间
Viral load decay
大体时间：8 weeks
Differences in log CMV viral load in plasma between baseline and 8 weeks
8 weeks
Viral load eradication
大体时间：3 and 8 weeks
Rate of patients with CMV viral load eradication, defined as the percentage of patients with a CMV PCR result below the level of quantification at 3 weeks and 8 weeks
3 and 8 weeks
Refractory CMV infection
大体时间：8 weeks
Rate of refractory CMV infection at 8 weeks, according to standard definition
8 weeks
Safety outcome 1
大体时间：90 days
Episodes of biopsy-proven acute rejection within 90 days
90 days
Safety Outcome 2
大体时间：90 days
Delta eGFR ml/min between baseline and day 90
90 days
Safety Outcome 3
大体时间：90 days
mTORi /MPA toxicity
90 days

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

Oriol Manuel

合作者

Hospital Vall d'Hebron
Centre Hospitalier Universitaire de Toulouse, FRANCE
Centre Hospitalier Universitaire Bordeaux

调查人员

  • 首席研究员：Oriol Manuel, Professor, MD、Service des maladies infectieuses, Centre hospitalier universitaire vaudois (CHUV)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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 (估计的)

2026年4月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年5月6日

上次提交的符合 QC 标准的更新

2026年4月29日

最后验证

2026年4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

  • 2025-02457
  • 2025-524845-28-00 (克蒂斯)
  • HumRes (注册表标识符：BASEC 2025-02457)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

After the study is completed, de-identified individual participant data may be shared. Data will be made available only after a formal request to the Principal Investigator (PI) and approval by the study's Scientific Committee. Data sharing will be limited to use for scientific research purposes and will follow all applicable privacy and ethical regulations.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

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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