A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mgAP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) inparticipants with respiratory insufficiency expected to be caused by respiratory viralinfection.
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.
Drug: AP1189, 100 mg
14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
Drug: Placebo
14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care
treatment
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
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
Thomas Jonassen, MD
+45 4015 6669
tj@synactpharma.com
Not Provided