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Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Sponsor: 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).
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2021-12-20
Completion Date
2026-06
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
AV-001 Injection
AV-001 (mpaBr) Cl for Injection 2.5 mg/mL
AV-001 Placebo Injection
D-PBS
Locations (5)
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Denver Health Medical Center
Denver, Colorado, United States
MedStar Health Research Institute, Inc.
Hyattsville, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
The Ohio State University
Columbus, Ohio, United States