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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
Sponsor: SynAct Pharma Aps
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2026-05-01
Completion Date
2027-08-01
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Interventions
AP1189, 100 mg
14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
Placebo
14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment
Locations (11)
University Clinical Hospital Mostar, Clinic for Infectious Diseases
Mostar, Herzegovina-Neretva Canton, Bosnia and Herzegovina
University Clinical Center Republic of Srpska, Clinic for Infectious Diseases
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Centre Sarajevo, Clinic for Infectious Diseases
Sarajevo, Sarajevo Canton, Bosnia and Herzegovina
Clinical Center of Montenegro, Clinic for Infectious Diseases
Podgorica, Podgorica Municipality, Montenegro
Te Toka Tumai Auckland, Auckland City Hospital
Auckland, New Zealand
Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
Auckland, New Zealand
Christchurch Hospital, 2 Riccarton Avenue,
Christchurch, New Zealand
MRINZ, 7 CSB Building, Wellington Hospital
Wellington, New Zealand
University Clinical Centre Nis, Clinic for Infectious Diseases
Niš, Nišava District, Serbia
Health Center Uzice, General Hospital Uzice
Užice, Zlatibor District, Serbia
University Clinical Centre of Serbia, Clinic for Infectious Diseases
Belgrade, Serbia