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

NCT07633288 | Recruiting Phase 2

• 1 other identifier: SynAct-CS009
• Study Type: interventional
• Target: 96
• Locations: 4 countries
• Sites: 11

Brief Summary

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.

Conditions

Respiratory Viral Infection

Keywords

Influenza; Respiratory Syncytial virus,; Corona virus

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Study Arms (2)

AP1189, 100 mg

EXPERIMENTAL

AP1189 tablet for oral use

Drug: AP1189, 100 mg

AP1189 matching placebo

EXPERIMENTAL

AP1189 tablet for oral use

Drug: Placebo

Interventions

AP1189, 100 mg DRUG

14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment

AP1189, 100 mg

Placebo DRUG

14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment

AP1189 matching placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment
• 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

Sponsors & Collaborators

• SynAct Pharma Aps: lead

Study Sites (11)

University Clinical Hospital Mostar, Clinic for Infectious Diseases

Mostar, Herzegovina-Neretva Canton, 88000, Bosnia and Herzegovina

RECRUITING

University Clinical Center Republic of Srpska, Clinic for Infectious Diseases

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

RECRUITING

University Clinical Centre Sarajevo, Clinic for Infectious Diseases

Sarajevo, Sarajevo Canton, 71000, Bosnia and Herzegovina

RECRUITING

Clinical Center of Montenegro, Clinic for Infectious Diseases

Podgorica, Podgorica Municipality, 81000, Montenegro

RECRUITING

Te Toka Tumai Auckland, Auckland City Hospital

Auckland, 1023, New Zealand

NOT YET RECRUITING

Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital

Auckland, 2025, New Zealand

NOT YET RECRUITING

Christchurch Hospital, 2 Riccarton Avenue,

Christchurch, 8011, New Zealand

NOT YET RECRUITING

MRINZ, 7 CSB Building, Wellington Hospital

Wellington, 6021, New Zealand

NOT YET RECRUITING

University Clinical Centre Nis, Clinic for Infectious Diseases

Niš, Nišava District, 18000, Serbia

RECRUITING

Health Center Uzice, General Hospital Uzice

Užice, Zlatibor District, 31000, Serbia

RECRUITING

University Clinical Centre of Serbia, Clinic for Infectious Diseases

Belgrade, 11000, Serbia

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

N-(3-(1-(2-nitrophenyl)-1H-pyrrol-2-yl)allylidenamino)guanidine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Thomas Jonassen, MD

CONTACT

+45 4015 6669; tj@synactpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4); SE (3); BO (3); MO (1)