HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial
Key facts
- Where
- Bordeaux and Toulouse Cedex 9, FranceSee the 2 sites
- Phase
- Phase 4
Where in France
- Centre hospitalier Universitaire de BordeauxBordeaux, FranceNot yet recruiting
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Oriol Manuel
- Trial code
- NCT07570433EU 2025-524845-28-00
- Record updated
- 6 May 2026
- Original description
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.Read full original descriptionShow less
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.
Inclusion: 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: 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; Active acute graft rejection or significant graft dysfunction requiring modification of the current immunosuppressive regimen, in the opinion of the investigator; Additional exclusion criteria for French sites:; Patient not affiliated to the French social security system; Patient under legal protection (guardianship, curatorship).