HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial
Starting soon · Phase 4
Conditions studied: CMV Infection
In brief
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.
Key facts
- Study ID
- NCT07570433
- Run by
- Oriol Manuel
- People needed
- 100
- Starts
- 2026-04-01
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Centre hospitalier universitaire Bordeaux (CHU Bordeaux) — Bourdeaux, Talence Cedex, France
- Centre hospitalier universitaire Toulouse (CHU Toulouse) — Toulouse, Toulouse, France
- Hospital Universitari Vall D'Hebron — Barcelona, Catalonia, Spain
- Centre hospitalier universitaire vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland
Full record on ClinicalTrials.gov
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