HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial
Key facts
- Who runs it
- Oriol Manuel
- Where
- Lausanne, SwitzerlandSee the siteAlso in 2 other countries, 3 sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 100 people, planned
- Started
- Apr 2026
- Expected to end
- Mar 2028
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 50% reduction in the dose of MPA
- Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus
- standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.
- Record updated
- 6 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in Switzerland
Also in 2 other countries, 3 sites
- Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, SwitzerlandContact: Oriol Manuel, Professor, MDNo longer taking part
About the trial
What the trial wants to find out
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.
Read full original descriptionShow less
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.
The 3 groups in the trial
- 50% reduction in the dose of MPA for a duration of minimum 21 daysTreatment being tested
with standard antiviral therapy
Treatment: 50% reduction in the dose of MPA
- switch of MPA to everolimus with adapted dose of tacrolimus, for a duration of at least 56 daysTreatment being tested
with standard antiviral therapy
Treatment: Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus
- Standard antiviral therapy without modulation of immunosuppressionExisting treatment, for comparison
Treatment: standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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.
- Record updated
- 6 May 2026