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

Launched by VASOMUNE THERAPEUTICS, INC. · Nov 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AV-001 Injection for hospitalized patients who have pneumonia and need extra oxygen to breathe. The goal is to find out if this treatment is safe and effective when given daily for up to 28 days. The trial will include 120 patients from various hospitals, who will be divided into different groups to receive either the AV-001 treatment or a placebo (a dummy treatment) along with their usual care.

To be eligible for the trial, patients must be hospitalized with pneumonia that started less than 48 hours ago and show specific symptoms, such as a high respiratory rate or fever. They should also be able to give their consent to participate. However, certain individuals, such as pregnant women or those with severe medical issues, will not be included. Participants can expect to receive regular check-ups during the trial and will help researchers learn more about how well this new treatment works for pneumonia.

Gender

ALL

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