Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia. (NCT05123755)
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.
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Hoag Memorial Hospital Presbyterian — Newport Beach, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Denver Health Medical Center — Denver, Colorado
- MedStar Health Research Institute, Inc. — Hyattsville, Maryland
- Henry Ford Health System — Detroit, Michigan
- The Ohio State University — Columbus, Ohio
📞 Contact the Study Coordinator
Phone: (949) 764-5987
Email: laurie.hendricks@hoag.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Respiratory Distress Syndrome
- Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway — Calgary, Alberta
- Molecular Epidemiology of Acute Respiratory Distress Syndrome (ARDS) — Boston, Massachusetts
- ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND) — Birmingham, Alabama
- Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome — Tucson, Arizona
- Macrophage Programing in Acute Lung Injury: MiniBAL — Denver, Colorado
- Vascular ARDS Recruitment After Inhaled Nitric Oxide — Boston, Massachusetts
Explore by condition: All Acute Respiratory Distress Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.