RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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.

Quick Facts

Study Start:2021-12-20
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05123755

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able and willing to give signed informed consent
  2. * 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;
  3. * Radiologic imaging (chest x-ray, CT scan, etc.) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation.
  4. * respiratory rate \> 30 breaths/min;
  5. * fever (\> 38.0ºC or \> 100.4o F);
  6. * leukopenia (≤ 4,000 WBC/mm3 or leukocytosis (≥ 12,000 WBC/mm3);
  7. * adults ≥ 70 years of age; altered mental status with no other recognized cause;
  8. * New onset of purulent sputum or change in character of sputum or increased respiratory secretions;
  9. * New onset or worsening cough, or dyspnea, or tachypnea;
  10. * Rales or bronchial breath sounds;
  11. * Female patients of reproductive potential must be on an effective contraceptive method
  1. * Pregnant and/or lactating women
  2. * Patients included in any other interventional trial
  3. * Use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at screening
  4. * Any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to:
  5. * Septic shock as defined by systolic blood pressure (SBP) \< 90 mmHg or diastolic blood pressure (DBP) of \< 60 mmHg;
  6. * Multiple organ failure;
  7. * Are moribund irrespective of the provision of treatments;
  8. * Any significant bleeding disorder or vasculitis;
  9. * Any serious, nonhealing wound, peptic ulcer or bone fracture;
  10. * Liver cirrhosis;
  11. * History of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension;
  12. * Severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate \<30mL/min/1.73m2;
  13. * ARDS risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose.
  14. * Any thromboembolic event within the past 3 months;
  15. * Symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia \> class II as per New York Heart Association (NYHA) classification;
  16. * History of autonomic disorders or uncontrolled hypotension
  17. * Hypersensitivity to drug products containing polyethylene glycol (PEG)
  18. * Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study

Contacts and Locations

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658-6100
United States
Denver Health Medical Center
Denver, Colorado, 80203
United States
University of Florida College of Medicine, Jacksonville
Jacksonville, Florida, 32611-5500
United States
MedStar Health Research Institute, Inc.
Hyattsville, Maryland, 20782
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
United States
The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Vasomune Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-20
Study Completion Date2025-03

Study Record Updates

Study Start Date2021-12-20
Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

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