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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment
University Clinical Hospital Mostar, Clinic for Infectious Diseases
Mostar, Herzegovina-Neretva Canton, Bosnia and Herzegovina
RECRUITINGUniversity Clinical Center Republic of Srpska, Clinic for Infectious Diseases
Banja Luka, Republika Srpska, Bosnia and Herzegovina
RECRUITINGUniversity Clinical Centre Sarajevo, Clinic for Infectious Diseases
Sarajevo, Sarajevo Canton, Bosnia and Herzegovina
RECRUITINGClinical Center of Montenegro, Clinic for Infectious Diseases
Podgorica, Podgorica Municipality, Montenegro
RECRUITINGTe Toka Tumai Auckland, Auckland City Hospital
Auckland, New Zealand
NOT_YET_RECRUITINGAotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
Auckland, New Zealand
NOT_YET_RECRUITINGChristchurch Hospital, 2 Riccarton Avenue,
Christchurch, New Zealand
NOT_YET_RECRUITINGMRINZ, 7 CSB Building, Wellington Hospital
Wellington, New Zealand
NOT_YET_RECRUITINGUniversity Clinical Centre Nis, Clinic for Infectious Diseases
Niš, Nišava District, Serbia
RECRUITINGHealth Center Uzice, General Hospital Uzice
Užice, Zlatibor District, Serbia
RECRUITING...and 1 more locations
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
Time frame: 28 days
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