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.
Vasomune Therapeutics, Inc.
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).
Description
Pneumonia is a leading cause of hospitalization among adults and children in the United States and has ranked among the top 10 causes of death according to the CDC. A large variety of microorganisms can cause pneumonia including respiratory viruses, bacteria and fungi and there are great geographic variations in their prevalence. In the United States, common causes of viral pneumonia are SARS-CoV-2, influenza and respiratory syncytial virus (RSV) and bacterial pneumonia are Streptococcus pneumoniae (pneumococcus). Emerging evidence indicates that the respiratory system mechanics of patients w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able and willing to give signed informed consent * Patients hospitalized with a presumed diagnosis of pneumonia of \< 48 hours duration requiring supplemental oxygen therapy. Eligible patients include those hospitalized for a separate non-infectious reason who subsequently develop a presumed pneumonia; * Radiologic imaging (chest x-ray, CT scan, etc.) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation. Signs and symptoms: At least 1 of the following signs: * respiratory rate \> 30 breaths/min…
Interventions
- DrugAV-001 Injection
AV-001 (mpaBr) Cl for Injection 2.5 mg/mL
- DrugAV-001 Placebo Injection
D-PBS
Locations (5)
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Denver Health Medical CenterDenver, Colorado
- MedStar Health Research Institute, Inc.Hyattsville, Maryland
- Henry Ford Health SystemDetroit, Michigan
- The Ohio State UniversityColumbus, Ohio