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New treatment option for Acute Respiratory Distress Syndrome
Official title Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
ClinicalTrials.gov ID: NCT05123755
What this study is testing
What is AV-001 Injection?
AV-001 Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute respiratory distress syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Radiologic imaging (chest x-ray, CT scan, etc.) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate...
- respiratory rate \> 30 breaths/min;
- fever (\> 38.0ºC or \> 100.4o F);
You likely can't join if
- Pregnant and/or lactating women
- Patients included in any other treatment 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;
See the full 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...
- 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...
- 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
- Pregnant and/or lactating women
- Patients included in any other treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Denver, Colorado, United States
- Hyattsville, Maryland, United States
- Detroit, Michigan, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Denver, Colorado, United States; Hyattsville, Maryland, United States; Detroit, Michigan, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.