HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial

NCT07570433 · tracked via the Priya Life Science France tracker

Sponsor

Oriol Manuel

Phase

Phase 4

Started

2026-04

Last updated

2026-05-06

Condition(s) studied

CMV Infection

Investigational drug(s) / intervention(s)

50% reduction in the dose of MPASwitch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimusstandard antiviral therapy along with maintenance of their initial immunosuppressive therapy.

50% reduction in the dose of MPA: 50% reduction in the dose of MPA with standard antiviral therapy

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

standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.: standard antiviral therapy along with maintenance of their initial immunosuppressive therapy (control group)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Viral load decay — 3 weeks
Differences in log CMV viral load in plasma between baseline and 3 weeks

Trial sites (4)

Facility	City	Region
Centre hospitalier universitaire Bordeaux (CHU Bordeaux)	Bourdeaux	Talence Cedex
Centre hospitalier universitaire Toulouse (CHU Toulouse)	Toulouse	Toulouse
Hospital Universitari Vall D'Hebron	Barcelona	Catalonia
Centre hospitalier universitaire vaudois (CHUV)	Lausanne	Canton of Vaud

Other trials for the same condition

Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07570433 on ClinicalTrials.gov ↗ ← All trials in France