Clinical Research Details

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

Study Description

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) to patients with pneumonia requiring supplemental oxygen therapy.

Inclusion/Exclusion Criteria

Inclusion criteria: 1.Patients hospitalized with or developing a presumed diagnosis of pneumonia of <72 hours duration requiring supplemental oxygen therapy. Eligible patients include those hospitalized for a separate non-infectious reason who subsequently develop a presumed pneumonia 2. Radiologic imaging (chest x-ray, CT scan, etc.) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation. Exclusion criteria: 1. Pregnant women 2. Patients included in any other interventional trial 3. Any concurrent serious medical condition that would preclude participation 4. Any thromboembolic event within the past 3 months 5. Symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia 6. History of autonomic disorders or uncontrolled hypotension

Open Enrollment

Contact Name: Toluwani Adenuga
Contact Phone: (904) 244-1106
Contact Email: