Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of AP1189 as Add-on to Standard Care in Respiratory Viral Infection Causing Respiratory Insufficiency

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a drug called AP1189 in people with respiratory insufficiency expected to be caused by respiratory viral infections such as influenza, respiratory syncytial virus, and coronavirus. This randomized, double-blind, placebo-controlled, multicenter proof-of-concept clinical trial aims to add AP1189 to the standard care and observe its impact compared to a placebo. The study plans to enroll 96 participants and is sponsored by SynAct Pharma Aps. Participants will be randomly assigned to one of two groups: one group receives 100 mg of oral AP1189 once daily for 14 days alongside standard care, while the other group receives a matching placebo under the same conditions. This treatment period lasts for 14 days, and the study is designed to measure outcomes up to 28 days after treatment begins. During the study, participants will undergo various assessments to track their health and response to treatment. Researchers will monitor key outcomes such as death, the need for invasive mechanical ventilation, use of extracorporeal membrane oxygenation (ECMO), cardiovascular organ support, and renal failure up to 28 days from baseline. The study includes hospital assessments and close monitoring to evaluate safety and efficacy, lasting through the treatment and follow-up periods.

A Randomized, Double-blind, Multicentre, Placebo-controlled 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