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

29. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
    • Talence Cedex
      • Bourdeaux, Talence Cedex, Frankrig, 33404
        • Centre hospitalier universitaire Bordeaux (CHU Bordeaux)
        • Kontakt:
        • Underforsker:
          • Lionel Couzi, Professor MD, PhD
    • Toulouse
      • Toulouse, Toulouse, Frankrig, 31059
        • Centre hospitalier universitaire Toulouse (CHU Toulouse)
        • Kontakt:
  • Schweiz
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Schweiz, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Dela Golshayan, Professor, MD PhD
        • Underforsker:
          • Julien Vionnet, MD, PhD
        • Underforsker:
          • Patrick Yerly, MD
  • Spanien
    • Catalonia
      • Barcelona, Catalonia, Spanien, 08035

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 50% reduction in the dose of MPA for a duration of minimum 21 days
with standard antiviral therapy
Medicin: 50% reduction in the dose of MPA
50% reduction in the dose of MPA with standard antiviral therapy
Andre navne:
  • Mycophenolsyre
  • Mycophenolatmofetil
Eksperimentel: switch of MPA to everolimus with adapted dose of tacrolimus, for a duration of at least 56 days
with standard antiviral therapy
Medicin: 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 navne:
  • everolimus
Aktiv komparator: Standard antiviral therapy without modulation of immunosuppression
Medicin: 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 navne:
  • kontrolgruppe

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oriol Manuel

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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Kliniske forsøg med CMV infektion

Kliniske forsøg med 50% reduction in the dose of MPA

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Betingelser

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