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

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). 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).

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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.

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

Condition
Acute Respiratory Distress Syndrome
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92658-6100

Denver

Denver Health Medical Center, Denver, Colorado, United States, 80203

Jacksonville

University of Florida College of Medicine, Jacksonville, Jacksonville, Florida, United States, 32611-5500

Hyattsville

MedStar Health Research Institute, Inc., Hyattsville, Maryland, United States, 20782

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Las Vegas

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States, 89102

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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;
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vasomune Therapeutics, Inc.,

Study Record Dates

2025-03