AP1189 added to standard care for adults hospitalized with respiratory viral infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized trial compares AP1189 100 mg once daily for 14 days versus placebo, as an add-on to standard of care, in adults hospitalized with respiratory insufficiency due to respiratory viruses. Participants must have confirmed infection (SARS-CoV-2, influenza A/B, or RSV) and meet respiratory severity criteria. The study aims to enroll 96 participants across multiple centers in Bosnia and Herzegovina. Safety and efficacy endpoints will be assessed over the 14-day treatment period, with follow-up as defined by the protocol. The trial is sponsored by SynAct Pharma and conducted at several university-affiliated infectious disease centers.

Why it matters

Who can join: the full rules

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

Where it's running

• University Clinical Hospital Mostar, Clinic for Infectious Diseases
  Mostar, Herzegovina-Neretva Canton, Bosnia and Herzegovina Recruiting
• University Clinical Center Republic of Srpska, Clinic for Infectious Diseases
  Banja Luka, Republika Srpska, Bosnia and Herzegovina Recruiting
• University Clinical Centre Sarajevo, Clinic for Infectious Diseases
  Sarajevo, Sarajevo Canton, Bosnia and Herzegovina Recruiting
• Clinical Center of Montenegro, Clinic for Infectious Diseases
  Podgorica, Podgorica Municipality, Montenegro Recruiting
• Te Toka Tumai Auckland, Auckland City Hospital
  Auckland, New Zealand Recruiting
• Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
  Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Thomas Jonassen, MD
• Email: tj@synactpharma.com
• Phone: +45 4015 6669

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.