Phase 2a Study Evaluating Safety and Effectiveness of AV-001 Injection in Hospitalized Adults With Pneumonia From COVID-19 or Other Respiratory Infections

What this Trial Is About

Researchers are studying adults hospitalized with presumed pneumonia caused by COVID-19 or other respiratory infections who require supplemental oxygen therapy. This Phase 2a, randomized, double-blind, placebo-controlled trial aims to evaluate the safety, tolerability, and efficacy of AV-001 Injection, a synthetic Angiopoietin-1 mimetic that targets vascular function to reduce harmful inflammation in the lungs. The study is sponsored by Vasomune Therapeutics, Inc. and includes up to 120 patients across different dose levels. Participants will be randomly assigned to receive either AV-001 Injection or a placebo injection alongside standard care, which may include treatments such as remdesivir or dexamethasone. AV-001 is given as a quick intravenous injection once daily, with doses starting at 12.5 micrograms per kilogram per day and increasing through several cohorts based on safety and efficacy data. The treatment period lasts up to 28 days or until the day before hospital discharge. There is potential for an additional cohort to explore intermediate dosing or effects in different patient groups. During the study, patients will be monitored closely with radiologic imaging and clinical assessments to evaluate lung involvement and response to treatment. Researchers will track safety and tolerability outcomes up to 60 days and measure efficacy outcomes up to 28 days. The study includes detailed observation of respiratory signs, symptoms, and laboratory markers, with ongoing safety reviews by an independent board. Participation duration varies depending on hospitalization and recovery.

Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.