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NCT07633288
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
Conditions: Respiratory Viral Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 96
Sponsor: SynAct Pharma Aps
Location: University Clinical Hospital Mostar, Clinic for Infectious Diseases Mostar Herzegovina-Neretva Canton
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07633288). StuddyBuddy aggregates publicly available trial information.