NCT05123755 Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 120 participants in total. It began in 2021-12-20 with a primary completion date of 2026-05.

Brief Summary

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).

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

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