Actively Recruiting
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Led by Vasomune Therapeutics, Inc. · Updated on 2026-02-27
120
Participants Needed
5
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 presumed pneumonia of less than 48 hours duration requiring supplemental oxygen
- Radiologic evidence of pulmonary involvement such as new or progressive infiltrate, consolidation, or cavitation
- At least one sign: respiratory rate over 30 breaths/min, fever above 38.0C (100.4F), leukopenia (4000 WBC/mm3 or less), leukocytosis (12000 WBC/mm3 or more), age 70 years or older, or altered mental status without other cause
- At least one symptom: new or changed purulent sputum, increased respiratory secretions, new or worsening cough, dyspnea, tachypnea, or rales/bronchial breath sounds
- Female patients of reproductive potential must use effective contraception
You will not qualify if you...
- Pregnant or lactating women
- Participation in any other interventional trial
- Use of endotracheal intubation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening
- Serious concurrent medical conditions or medications that prevent participation, including septic shock (SBP < 90 mmHg or DBP < 60 mmHg), multiple organ failure, moribund status, significant bleeding disorder or vasculitis, serious wounds, peptic ulcers, bone fractures, liver cirrhosis, hypertensive crisis or poorly controlled blood pressure, severe renal insufficiency (eGFR <30mL/min/1.73m2)
- ARDS risk factors such as aspiration pneumonia, non-cardiac shock, trauma, blood transfusion, or drug overdose
- Thromboembolic event within past 3 months
- Symptomatic congestive heart failure or poorly controlled cardiac arrhythmia above NYHA class II
- History of autonomic disorders or uncontrolled hypotension
- Hypersensitivity to drugs containing polyethylene glycol (PEG)
- Any condition that the Principal Investigator believes could jeopardize patient safety or study objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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