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A 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)

2026年7月27日 更新者：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

A 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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

96

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 塞尔维亚
      • Belgrade、塞尔维亚、11000
        • 招聘中
        • University Clinical Centre of Serbia, Clinic for Infectious Diseases
        • 接触：
    • Nišava District
      • Niš、Nišava District、塞尔维亚、18000
        • 招聘中
        • University Clinical Centre Nis, Clinic for Infectious Diseases
        • 接触：
    • Zlatibor District
      • Užice、Zlatibor District、塞尔维亚、31000
        • 招聘中
        • Health Center Uzice, General Hospital Uzice
        • 接触：
  • 新西兰
      • Auckland、新西兰、1023
        • 招聘中
        • Te Toka Tumai Auckland, Auckland City Hospital
        • 接触：
          • Tom Hills, Dr.
      • Auckland、新西兰、2025
        • 招聘中
        • Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
        • 接触：
          • Michael Borrie, Dr.
      • Christchurch、新西兰、8011
        • 尚未招聘
        • Christchurch Hospital, 2 Riccarton Avenue,
        • 接触：
          • Seton Henderson, Dr.
      • Wellington、新西兰、6021
        • 招聘中
        • MRINZ, 7 CSB Building, Wellington Hospital
        • 接触：
          • Max Bloomfield, Dr.
  • 波斯尼亚和黑塞哥维那
    • Herzegovina-Neretva Canton
      • Mostar、Herzegovina-Neretva Canton、波斯尼亚和黑塞哥维那、88000
        • 招聘中
        • University Clinical Hospital Mostar, Clinic for Infectious Diseases
        • 接触：
    • Republika Srpska
      • Banja Luka、Republika Srpska、波斯尼亚和黑塞哥维那、78000
        • 招聘中
        • University Clinical Center Republic of Srpska, Clinic for Infectious Diseases
        • 接触：
    • Sarajevo Canton
      • Sarajevo、Sarajevo Canton、波斯尼亚和黑塞哥维那、71000
        • 招聘中
        • University Clinical Centre Sarajevo, Clinic for Infectious Diseases
        • 接触：
  • 黑山
    • Podgorica Municipality
      • Podgorica、Podgorica Municipality、黑山、81000
        • 招聘中
        • Clinical Center of Montenegro, Clinic for Infectious Diseases
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：AP1189, 100 mg
AP1189 tablet for oral use
药品：AP1189, 100 mg
14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
实验性的：AP1189 matching placebo
AP1189 tablet for oral use
药品：Placebo
14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of participants meeting the composite endpoint, consisting of either death, invasive mechanical ventilation, ECMO, cardiovascular organ support, new occurrences of renal failure, hemofiltration or dialysis from baseline to day 28
大体时间：28 days
28 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

SynAct Pharma Aps

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SynAct-CS009

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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