What is AP1189 studying for respiratory insufficiency caused by viral infection?

AP1189 is being studied to evaluate its safety and effectiveness as an add-on treatment for respiratory insufficiency caused by infections like SARS-CoV-2, Influenza, or RSV. The trial aims to understand if AP1189 can improve outcomes when combined with standard care. The study is sponsored by SynAct Pharma Aps and involves hospitalized patients.

Who may be eligible for this respiratory viral infection clinical trial?

Adults aged 18 years or older hospitalized with respiratory insufficiency due to viral infection such as SARS-CoV-2, Influenza A or B, or RSV may be eligible. Participants must have certain oxygen saturation levels and not be pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this respiratory viral infection clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect all treatments and visits related to the trial to be free of charge.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07633288

Study to Test the Safety and Effectiveness of AP1189 Compared to Placebo Added to Standard Care in Adults with Respiratory Insufficiency Caused by Viral Infection

Led by SynAct Pharma Aps · Updated on 2026-07-28

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a once-daily oral medication called AP1189, at a dose of 100 mg, compared to a placebo in participants who have respiratory insufficiency expected to be caused by respiratory viral infections such as SARS-CoV-2, Influenza A or B, or RSV. This study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to include 96 hospitalized participants. The goal is to assess AP1189 as an add-on treatment to the standard care provided for these respiratory infections. Participants will be randomly assigned in equal numbers to receive either AP1189 tablets or matching placebo tablets once daily for 14 days, alongside their standard of care treatment. The study monitors participants during this 14-day treatment period to evaluate treatment outcomes and safety. During the study, participants will be assessed for a composite outcome including death, need for invasive mechanical ventilation or ECMO, cardiovascular organ support, or new renal failure within 28 days. The study includes clinical evaluations, oxygen saturation measurements, and safety monitoring during and after treatment. Overall participation lasts at least 28 days to capture these outcomes and monitor participant health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Written informed consent obtained before any study procedures
Positive for SARS-COV-2, Influenza A or B, or RSV by bedside LAF test or PCR
Hospitalized with respiratory insufficiency expected from viral infection, with SpO2 ≤ 93% on ambient air or oxygen support, or ≤ 85% if hypercapnic respiratory failure
Disease duration less than 15 days from first symptom
Females of childbearing potential must use reliable contraception or be post-menopausal or surgically sterilized
Negative pregnancy test at screening and baseline for females of childbearing potential
Vulnerable participants included as subgroups
Screened within 24 hours of hospital admission or transfer due to respiratory distress

You will not qualify if you...

Imminent death expected regardless of treatment
Already requiring invasive mechanical ventilation, ECMO, cardiovascular organ support, or renal failure at screening
Participating in other drug clinical trials
Unable to comply with study protocol in the investigator's opinion
Use of immunosuppressive or immunomodulatory treatments for chronic autoimmune diseases within 3 months prior to screening (except standard steroids for viral infection)
Pregnant or breastfeeding women

Research Team

Thomas Jonassen, MD

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