RecruitingPhase 2NCT05123755

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

A Randomized, Double-blind, Placebo-controlled, Phase 2a Multiple Ascending Dose Study to Examine the Safety, Tolerability and Efficacy of AV-001 Injection in Patients Hospitalized With Pneumonia Due To COVID-19 or Other Respiratory Infections.

Sponsor

Vasomune Therapeutics, Inc.

Enrollment

120 participants

Start Date

Dec 20, 2021

Study Type

INTERVENTIONAL

Conditions

Pneumonia Respiratory Infection Acute Respiratory Distress Syndrome Viral or Bacterial Infections Pneumonia, Viral COVID-19 Acute Respiratory Distress Syndrome

Summary

A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug in patients hospitalized with pneumonia who need supplemental oxygen. The drug aims to help patients recover faster from pneumonia by targeting the underlying disease process. This is a Phase 2a study, meaning it is in early stages of testing for safety and the right dose range. You may be eligible if... - You are 18 years or older - You are hospitalized with pneumonia of less than 48 hours' duration and require supplemental oxygen - Chest imaging shows signs of pneumonia (new infiltrate, consolidation, or cavitation) - You have at least one sign (e.g., fever, rapid breathing, abnormal white cell count) and one symptom (e.g., new cough, purulent sputum, difficulty breathing) You may NOT be eligible if... - You are pregnant or breastfeeding - You are currently on mechanical ventilation (intubated) or ECMO - You have septic shock (very low blood pressure) or multiple organ failure - You have severe kidney disease (eGFR below 30) - You have liver cirrhosis or advanced liver disease - You have had a thromboembolic event (clot) in the past 3 months - You have symptomatic congestive heart failure or poorly controlled arrhythmia - You have a known allergy to polyethylene glycol (PEG) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.