Actively Recruiting
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.
Led by Vasomune Therapeutics, Inc. · Updated on 2026-02-27
120
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults hospitalized with presumed pneumonia caused by COVID-19 or other respiratory infections who require supplemental oxygen therapy. This Phase 2a, randomized, double-blind, placebo-controlled trial aims to evaluate the safety, tolerability, and efficacy of AV-001 Injection, a synthetic Angiopoietin-1 mimetic that targets vascular function to reduce harmful inflammation in the lungs. The study is sponsored by Vasomune Therapeutics, Inc. and includes up to 120 patients across different dose levels. Participants will be randomly assigned to receive either AV-001 Injection or a placebo injection alongside standard care, which may include treatments such as remdesivir or dexamethasone. AV-001 is given as a quick intravenous injection once daily, with doses starting at 12.5 micrograms per kilogram per day and increasing through several cohorts based on safety and efficacy data. The treatment period lasts up to 28 days or until the day before hospital discharge. There is potential for an additional cohort to explore intermediate dosing or effects in different patient groups. During the study, patients will be monitored closely with radiologic imaging and clinical assessments to evaluate lung involvement and response to treatment. Researchers will track safety and tolerability outcomes up to 60 days and measure efficacy outcomes up to 28 days. The study includes detailed observation of respiratory signs, symptoms, and laboratory markers, with ongoing safety reviews by an independent board. Participation duration varies depending on hospitalization and recovery.
CONDITIONS
Brief Title
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give signed informed consent
- Hospitalized with a presumed diagnosis of pneumonia less than 48 hours duration requiring supplemental oxygen therapy
- Radiologic imaging evidence of pulmonary involvement with new and persistent or progressive infiltrate, consolidation, or cavitation
- At least 1 of the following signs: respiratory rate > 30 breaths/min; fever > 38.0C or > 100.4F; leukopenia 64,000 WBC/mm3 or leukocytosis 65,000 WBC/mm3; adults 65 70 years of age; altered mental status with no other recognized cause
- At least 1 of the following symptoms: new onset of purulent sputum or change in character of sputum or increased respiratory secretions; new onset or worsening cough, dyspnea, or tachypnea; rales or bronchial breath sounds
- Female patients of reproductive potential must be on an effective contraceptive method
You will not qualify if you...
- Pregnant and/or lactating women
- Patients included in any other interventional trial
- Use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at screening
- Serious medical conditions or medications that preclude participation including septic shock, multiple organ failure, moribund state, significant bleeding disorder, nonhealing wound, peptic ulcer, bone fracture, liver cirrhosis
- History of hypertensive crisis, poorly controlled hypertension or hypotension
- Severe renal insufficiency or end stage renal disease with estimated glomerular filtration rate <30mL/min/1.73m2
- ARDS risk factors such as aspiration pneumonia, non-cardiac shock, trauma, blood transfusion, or drug overdose
- Thromboembolic event within the past 3 months
- Symptomatic congestive heart failure or poorly controlled cardiac arrhythmia > class II NYHA classification
- History of autonomic disorders or uncontrolled hypotension
- Hypersensitivity to drug products containing polyethylene glycol (PEG)
- Any other condition that may jeopardize patient safety or study objectives
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive multiple intravenous doses of AV-001 Injection or a placebo, alongside standard of care, to treat pneumonia due to COVID-19 or other respiratory infections.
Multiple IV administrations during hospitalization
Duration - Up to 32 days following treatment
Participants are monitored for safety and tolerability after treatment ends, with additional assessments up to Day 60.
Visits as scheduled up to Day 60
Trial Site Locations
Total: 5 locations
1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658-6100
Actively Recruiting
2
Denver Health Medical Center
Denver, Colorado, United States, 80203
Actively Recruiting
3
MedStar Health Research Institute, Inc.
Hyattsville, Maryland, United States, 20782
Actively Recruiting
4
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
5
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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