NCT05123755 · Vasomune Therapeutics, Inc.
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
What this study is about
A Phase 2a, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy.
View original scientific description
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).
Interventions
DRUG
AV-001 Injection
AV-001 (mpaBr) Cl for Injection 2.5 mg/mL
DRUG
AV-001 Placebo Injection
D-PBS
Primary outcome measures
Safety and tolerability of multiple doses of IV administrations of AV-001 Injection compared with AV-001 placebo Injection in hospitalized patients with pneumonia due to COVID-19 and/or other respiratory infections.
Time frame: Up to Day 60
* Number of patients with any serious adverse event (SAE) (day 1 to 60/EOS) * Number of patients with any treatment emergent adverse event (TEAE) (day 1 to 60/EOS) AE assessments (day 1 to 60/EOS)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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;
- fever (\> 38.0ºC or \> 100.4o F);
- leukopenia (≤ 4,000 WBC/mm3 or leukocytosis (≥ 12,000 WBC/mm3);
- adults ≥ 70 years of age; altered mental status with no other recognized cause; AND 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, or dyspnea, or tachypnea;
Where
- Newport Beach, California
- Denver, Colorado
- Hyattsville, Maryland
- Detroit, Michigan
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations