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A Randomized, Double-blind, Multicentre, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses (RESPIRE)

2. juni 2026 opdateret af: SynAct Pharma Aps

A Randomized, Double-blind, Multicentre, Placebo-controlled, Proof-of-concept Clinical Trial Evaluating the Safety and Efficacy of the Biased Melanocortin Agonist AP1189 Versus Placebo as an add-on to Standard of Care (SOC) in Participants With RESPIRatory Insufficiency Expected to be Caused by Infection With Respiratory Viruses, Including Influenza, Respiratory Syncytial Virus, and Coronavirus

The study is a randomized, double-blind, multicentre, placebo-controlled, proof-of-concept clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of the trial is to evaluate the efficacy and safety 14 days daily treatment of oral AP1189 at a dose or 100 mg as an add-on to SOC treatment.

The aim is to have 96 participants randomized and completing the study. They will be randomized in a 1:1 ratio to one of the following two groups:

  • Group A (48 participants): AP1189 tablets 100 mg, once daily for 14 days as an add-on to SOC
  • Group B (48 participants): placebo tablets once daily for 14 days as an add-on to SOC.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

96

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Bosnien-Hercegovina
    • Herzegovina-Neretva Canton
      • Mostar, Herzegovina-Neretva Canton, Bosnien-Hercegovina, 88000
        • Rekruttering
        • University Clinical Hospital Mostar, Clinic for Infectious Diseases
        • Kontakt:
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnien-Hercegovina, 78000
        • Rekruttering
        • University Clinical Center Republic of Srpska, Clinic for Infectious Diseases
        • Kontakt:
    • Sarajevo Canton
      • Sarajevo, Sarajevo Canton, Bosnien-Hercegovina, 71000
        • Rekruttering
        • University Clinical Centre Sarajevo, Clinic for Infectious Diseases
        • Kontakt:
  • Montenegro
    • Podgorica Municipality
      • Podgorica, Podgorica Municipality, Montenegro, 81000
        • Rekruttering
        • Clinical Center of Montenegro, Clinic for Infectious Diseases
        • Kontakt:
  • New Zealand
      • Auckland, New Zealand, 1023
        • Ikke rekrutterer endnu
        • Te Toka Tumai Auckland, Auckland City Hospital
        • Kontakt:
          • Tom Hills, Dr.
      • Auckland, New Zealand, 2025
        • Ikke rekrutterer endnu
        • Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
        • Kontakt:
          • Michael Borrie, Dr.
      • Christchurch, New Zealand, 8011
        • Ikke rekrutterer endnu
        • Christchurch Hospital, 2 Riccarton Avenue,
        • Kontakt:
          • Seton Henderson, Dr.
      • Wellington, New Zealand, 6021
        • Ikke rekrutterer endnu
        • MRINZ, 7 CSB Building, Wellington Hospital
        • Kontakt:
          • Max Bloomfield, Dr.
  • Serbien
      • Belgrade, Serbien, 11000
        • Rekruttering
        • University Clinical Centre of Serbia, Clinic for Infectious Diseases
        • Kontakt:
    • Nišava District
      • Niš, Nišava District, Serbien, 18000
        • Rekruttering
        • University Clinical Centre Nis, Clinic for Infectious Diseases
        • Kontakt:
    • Zlatibor District
      • Užice, Zlatibor District, Serbien, 31000
        • Rekruttering
        • Health Center Uzice, General Hospital Uzice
        • Kontakt:

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:

  • Written informed consent has been obtained prior to initiating any study-specific procedures
  • Expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV as confirmed by a bedside LAF test, qualitative PCR, or quantitative PCR (Q-PCR).
  • Hospitalized with respiratory insufficiency expected to be caused by respiratory viral infection defined by SpO2 ≤ 93 % on ambient air or supplementary oxygen supply via nasal catheter or facial mask (WHO Clinical Progression Scale score 5 or 6). Or in participants with hypercapnic respiratory failure (usually due to COPD) the SpO2 threshold is SpO2 ≤ 85 %.
  • Duration of disease from first symptom< 15 days before enrolment
  • Females of childbearing potential using reliable means of contraception or are post-menopausal or are surgically sterilized
  • Females of childbearing potential with a negative pregnancy test at screening and baseline
  • As the morbidity and mortality of respiratory infections are many fold increased in vulnerable participants, vulnerable participants are not excluded but included as subgroups.
  • Screened within 24 hours of hospital admission to the hospital, or within 24 hours of receiving a patient, if the patient is transferred from another hospital or another hospital department due to respiratory distress

Exclusion Criteria:

  • In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment
  • Already meeting any component of the primary composite endpoint at screening, defined as the presence of any of the following: invasive mechanical ventilation, ECMO, cardiovascular organ support (balloon pump or inotropes/vasopressors), or renal failure (Cockcroft-Gault estimated creatinine clearance <15 ml/min, haemofiltration or dialysis). Note: participants qualifying under inclusion criterion 8b (pre-existing renal insufficiency or dialysis) are excluded only if they meet any of the other criteria (invasive mechanical ventilation, ECMO, or cardiovascular organ support). Participants who are physically located in an ICU or HDU but do not meet the above physiological criteria are not excluded on that basis alone.
  • Participating in other drug clinical trials
  • Any condition that in the view of the screening physician would suggest that the participant is unable to comply with study protocol and procedures
  • Participants who have initiated treatment within 3 months prior to screening with immunosuppressive or immunomodulatory treatments for chronic autoimmune diseases. Administration of steroids or other immunosuppressive medicines implemented as standard-of-care for the treatment of the respiratory viral infection is acceptable. Asthma/COPD participants are allowed to use their habitual inhalation spray containing adrenocortical hormone.
  • Pregnant women or nursing (breastfeeding) mothers

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AP1189, 100 mg
AP1189 tablet for oral use
Medicin: AP1189, 100 mg
14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
Eksperimentel: AP1189 matching placebo
AP1189 tablet for oral use
Medicin: Placebo
14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Death
Tidsramme: 28 days
28 days
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Invasive mechanical ventilation
Tidsramme: 28 days
28 days
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Extra Corporeal Membrane Oxygenation (ECMO)
Tidsramme: 28 days
28 days
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Cardiovascular organ support
Tidsramme: 28 days
28 days
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Renal failure
Tidsramme: 28 days
28 days

Samarbejdspartnere og efterforskere

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

Sponsor

SynAct Pharma Aps

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 (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SynAct-CS009

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Respiratorisk viral infektion

Kliniske forsøg med AP1189, 100 mg

Søg i lignende forsøg

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Betingelser

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