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)

June 2, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bosnia and Herzegovina
    • Herzegovina-Neretva Canton
      • Mostar, Herzegovina-Neretva Canton, Bosnia and Herzegovina, 88000
        • Recruiting
        • University Clinical Hospital Mostar, Clinic for Infectious Diseases
        • Contact:
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • Recruiting
        • University Clinical Center Republic of Srpska, Clinic for Infectious Diseases
        • Contact:
    • Sarajevo Canton
      • Sarajevo, Sarajevo Canton, Bosnia and Herzegovina, 71000
        • Recruiting
        • University Clinical Centre Sarajevo, Clinic for Infectious Diseases
        • Contact:
  • Montenegro
    • Podgorica Municipality
      • Podgorica, Podgorica Municipality, Montenegro, 81000
        • Recruiting
        • Clinical Center of Montenegro, Clinic for Infectious Diseases
        • Contact:
  • New Zealand
      • Auckland, New Zealand, 1023
        • Not yet recruiting
        • Te Toka Tumai Auckland, Auckland City Hospital
        • Contact:
          • Tom Hills, Dr.
      • Auckland, New Zealand, 2025
        • Not yet recruiting
        • Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
        • Contact:
          • Michael Borrie, Dr.
      • Christchurch, New Zealand, 8011
        • Not yet recruiting
        • Christchurch Hospital, 2 Riccarton Avenue,
        • Contact:
          • Seton Henderson, Dr.
      • Wellington, New Zealand, 6021
        • Not yet recruiting
        • MRINZ, 7 CSB Building, Wellington Hospital
        • Contact:
          • Max Bloomfield, Dr.
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Centre of Serbia, Clinic for Infectious Diseases
        • Contact:
    • Nišava District
      • Niš, Nišava District, Serbia, 18000
        • Recruiting
        • University Clinical Centre Nis, Clinic for Infectious Diseases
        • Contact:
    • Zlatibor District
      • Užice, Zlatibor District, Serbia, 31000
        • Recruiting
        • Health Center Uzice, General Hospital Uzice
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AP1189, 100 mg
AP1189 tablet for oral use
Drug: AP1189, 100 mg
14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
Experimental: AP1189 matching placebo
AP1189 tablet for oral use
Drug: Placebo
14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Death
Time Frame: 28 days
28 days
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Invasive mechanical ventilation
Time Frame: 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)
Time Frame: 28 days
28 days
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Cardiovascular organ support
Time Frame: 28 days
28 days
Treatment effect of AP1189 versus placebo evaluated from baseline to day 28 on the composite endpoint: Renal failure
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SynAct Pharma Aps

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SynAct-CS009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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