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

29. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
    • Talence Cedex
      • Bourdeaux, Talence Cedex, Frankrike, 33404
        • Centre hospitalier universitaire Bordeaux (CHU Bordeaux)
        • Ta kontakt med:
        • Underetterforsker:
          • Lionel Couzi, Professor MD, PhD
    • Toulouse
      • Toulouse, Toulouse, Frankrike, 31059
        • Centre hospitalier universitaire Toulouse (CHU Toulouse)
        • Ta kontakt med:
  • Spania
    • Catalonia
      • Barcelona, Catalonia, Spania, 08035
        • Hospital Universitari Vall d'Hebron
        • Ta kontakt med:
  • Sveits
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Sveits, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Dela Golshayan, Professor, MD PhD
        • Underetterforsker:
          • Julien Vionnet, MD, PhD
        • Underetterforsker:
          • Patrick Yerly, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 50% reduction in the dose of MPA for a duration of minimum 21 days
with standard antiviral therapy
Legemiddel: 50% reduction in the dose of MPA
50% reduction in the dose of MPA with standard antiviral therapy
Andre navn:
  • Mykofenolsyre
  • Mykofenolatmofetil
Eksperimentell: switch of MPA to everolimus with adapted dose of tacrolimus, for a duration of at least 56 days
with standard antiviral therapy
Legemiddel: 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
Andre navn:
  • everolimus
Aktiv komparator: Standard antiviral therapy without modulation of immunosuppression
Legemiddel: standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.
standard antiviral therapy along with maintenance of their initial immunosuppressive therapy (control group)
Andre navn:
  • kontrollgruppe

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Viral load decay
Tidsramme: 3 weeks
Differences in log CMV viral load in plasma between baseline and 3 weeks
3 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in CMV-specific immune signature score
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Viral load decay
Tidsramme: 8 weeks
Differences in log CMV viral load in plasma between baseline and 8 weeks
8 weeks
Viral load eradication
Tidsramme: 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
Tidsramme: 8 weeks
Rate of refractory CMV infection at 8 weeks, according to standard definition
8 weeks
Safety outcome 1
Tidsramme: 90 days
Episodes of biopsy-proven acute rejection within 90 days
90 days
Safety Outcome 2
Tidsramme: 90 days
Delta eGFR ml/min between baseline and day 90
90 days
Safety Outcome 3
Tidsramme: 90 days
mTORi /MPA toxicity
90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Oriol Manuel

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Oriol Manuel, Professor, MD, Service des maladies infectieuses, Centre hospitalier universitaire vaudois (CHUV)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. april 2026

Primær fullføring (Antatt)

1. januar 2028

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-02457
  • 2025-524845-28-00 (Ctis)
  • HumRes (Registeridentifikator: BASEC 2025-02457)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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