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AV-001 Injection for Hospitalized Pneumonia Patients

Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.

Recruiting Phase 2 Interventional Study

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

Prior Safety Data This treatment has already been tested in at least one earlier human trial.

At a Glance

Age: 18 and older
Sex: Any
Trial phase: Phase 2
Study type: Interventional
Purpose: Treatment
Participants needed: 120 (estimated)
Sponsor: Vasomune Therapeutics, Inc. · Industry

Who this trial is looking for

This trial is looking for patients in the hospital with pneumonia who need extra oxygen. If you join, you will receive either the AV-001 Injection or a placebo each day until you leave the hospital or for up to 28 days.

Are You a Good Fit for This Trial?

You may be able to join if

I can give signed informed consent.
I have been hospitalized with pneumonia for less than 48 hours.
I need supplemental oxygen therapy.
I have chest imaging showing lung issues.
I have a high respiratory rate or fever.
I am 70 years or older.
I have new or worsening cough or difficulty breathing.
I am female and using effective contraception.

You may not be able to join if

I am pregnant or breastfeeding.
I am participating in another trial.
I need mechanical ventilation or ECMO.
I have a serious medical condition that affects my safety.
I have had significant bleeding issues.
I have severe kidney problems.
I have certain heart conditions or uncontrolled blood pressure.
I have a history of serious allergic reactions to PEG.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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 patien…

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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

Contacts

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AV-001 Injection for Hospitalized Pneumonia Patients

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