Testing a new injection for hospitalized pneumonia patients

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.

This study is testing a new injection for hospitalized pneumonia patients to see if it helps them feel better and recover faster while they receive standard care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vasomune Therapeutics, Inc. (Industry-sponsored)
• Locations: 5 sites (Newport Beach, California and 4 other locations)
• Trial ID: NCT05123755 on ClinicalTrials.gov

What this trial studies

This Phase 2a study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety, tolerability, and efficacy of AV-001 Injection in hospitalized patients with presumed pneumonia requiring supplemental oxygen. A total of 120 patients will be recruited from up to 25 hospitals, with participants receiving either the AV-001 Injection or a placebo alongside standard care. The study will monitor patients daily until discharge or for a maximum of 28 days to assess the treatment's impact on pneumonia symptoms and recovery.

Who should consider this trial

Good fit: Ideal candidates are hospitalized patients with a presumed diagnosis of pneumonia requiring supplemental oxygen therapy.

Not a fit: Patients with pneumonia not requiring supplemental oxygen or those with a diagnosis longer than 48 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve recovery outcomes for patients hospitalized with pneumonia.

How similar studies have performed: Previous studies have shown promise in similar approaches for treating pneumonia, but this specific intervention is novel.

Eligibility criteria

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;
* Rales or bronchial breath sounds;

  * Female patients of reproductive potential must be on an effective contraceptive method

Exclusion Criteria:

* 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
* Any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to:

  * Septic shock as defined by systolic blood pressure (SBP) \< 90 mmHg or diastolic blood pressure (DBP) of \< 60 mmHg;
  * Multiple organ failure;
  * Are moribund irrespective of the provision of treatments;
  * Any significant bleeding disorder or vasculitis;
  * Any serious, nonhealing wound, peptic ulcer or bone fracture;
  * Liver cirrhosis;
  * History of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension;
  * Severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate \<30mL/min/1.73m2;
  * ARDS risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose.
* Any thromboembolic event within the past 3 months;
* Symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia \> class II as per New York Heart Association (NYHA) classification;
* History of autonomic disorders or uncontrolled hypotension
* Hypersensitivity to drug products containing polyethylene glycol (PEG)
* Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study

Where this trial is running

Newport Beach, California and 4 other locations

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)
• Denver Health Medical Center — Denver, Colorado, United States (Recruiting)
• MedStar Health Research Institute, Inc. — Hyattsville, Maryland, United States (Recruiting)
• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Conditions Acute Respiratory Distress Syndrome; Viral or Bacterial Infections; Pneumonia; Pneumonia, Viral; Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome