What side effects are associated with this type of intervention?

Common treatments for Acute Respiratory Distress Syndrome (ARDS) include neuromuscular blockade, glucocorticoids, and prone ventilation. Neuromuscular blockade can cause prolonged neuromuscular weakness. Glucocorticoids may lead to hyperglycemia and increased infection risk, especially if used late in the disease course. Prone ventilation, while reducing mortality, can result in pressure sores and dislodgement of tubes.

What prior FDA approvals exist?

To date, there are no FDA-approved pharmacological treatments specifically for Acute Respiratory Distress Syndrome (ARDS). Most therapies, including those aimed at reducing inflammation or enhancing lung repair, have not shown consistent benefits in large-scale clinical trials. Investigational treatments like AV-001 Injection are being studied, but their mechanisms and efficacy remain under evaluation. Current management of ARDS primarily involves supportive care, such as mechanical ventilation and prone positioning, rather than specific drug therapies.

What other types of research exist?

Promising novel alternatives to AV-001 Injection for ARDS treatment include: 1) High-frequency oscillatory ventilation (HFOV), although it has no economic advantage and further research is suggested. 2) Surfactant substitution therapy, which has shown preliminary positive results in animal models. 3) Aspirin (ASA), which has shown potential in preclinical models and meta-analyses but requires further human trials. 4) Hemoperfusion with polymyxin-B immobilized fiber, which improved oxygenation and survival rates in AE-IPF patients. 5) Intravenous recombinant thrombomodulin (rhTM), although it did not improve survival in a recent trial and had higher bleeding risks. These alternatives should be discussed with a healthcare provider to determine the best course of action.

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AV-001 for COVID-19

Phase 2

Recruiting

Research Sponsored by Vasomune Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients of reproductive potential must be on an effective contraceptive method

Presence of 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 with altered mental status with no other recognized cause

Must not have

Use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 60

Summary

This trial tests AV-001 Injection, a treatment to strengthen lung blood vessels and reduce inflammation, in hospitalized pneumonia patients needing extra oxygen. AV-001 works by mimicking a natural protein to make lung blood vessels stronger and less leaky.

Who is the study for?

This trial is for hospitalized patients with presumed pneumonia needing extra oxygen but not on mechanical ventilation or ECMO. They should have symptoms like new cough, fever, or breathlessness and signs of lung infection on imaging. Adults over 70 must be mentally stable and women able to bear children need effective contraception.

What is being tested?

The study tests AV-001 Injection versus a placebo in addition to standard care for pneumonia. It's randomized and double-blind, meaning neither the doctors nor patients know who gets the real treatment. Patients receive daily doses until day 28 or hospital discharge.

What are the potential side effects?

While specific side effects are not listed here, common ones from similar treatments may include injection site reactions, allergic responses, gastrointestinal issues like nausea or diarrhea, headaches, dizziness, and potential interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using effective birth control.

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I have a high fever, fast breathing, unusual white blood cell count, or confusion if over 70.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on a ventilator or ECMO machine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of multiple doses of IV administrations of AV-001 Injection compared with AV-001 placebo Injection in hospitalized patients with pneumonia due to COVID-19 and/or other respiratory infections.

Secondary study objectives

Efficacy of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection in patients hospitalized with pneumonia due to COVID-19 and/or other respiratory infections.

Other study objectives

Effect of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection on disease biomarker ICAM-1, in in patients with pneumonia due to COVID-19 and/or other respiratory infections.

Effect of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection on disease biomarker IL-8 in patients with pneumonia due to COVID-19 and/or other respiratory infections.

Effect of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection on disease biomarker IP-10 in patients with pneumonia due to COVID-19 and/or other respiratory infections.

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Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: AV-001 Injection with standard of care (SOC).Active Control1 Intervention

A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) 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). Doses of AV-001 Injection will start with 12.5 μg/kg/day in cohort 1 and are anticipated to increase to 25 μg/kg/day in cohort 2, 56 μg/kg/day in cohort 3 and to be determined (TBD) in cohort 4. The dose for cohort 4 will be determined by the Data Safety Monitoring Board (DSMB) based on emerging data from cohorts 1, 2 and 3.

Group II: AV-001 Placebo Injection with standard of care (SOC).Placebo Group1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Respiratory Distress Syndrome (ARDS) include mechanical ventilation, glucocorticoids, and neuromuscular blockade. Mechanical ventilation supports oxygenation and reduces the work of breathing by using low tidal volumes to prevent ventilator-induced lung injury. Glucocorticoids, such as methylprednisolone and dexamethasone, reduce inflammation and improve oxygenation in early moderate to severe ARDS. Neuromuscular blockade can improve oxygenation and reduce ventilator asynchrony in severe cases. Investigational therapies like AV-001 Injection are being studied for their potential to enhance lung repair and reduce inflammation. These treatments are crucial as they aim to stabilize respiratory function, reduce lung injury, and improve survival outcomes in ARDS patients.

Adult respiratory distress syndrome: diagnosis and management.Emerging drugs for treating the acute respiratory distress syndrome.Prevention or Treatment of Ards With Aspirin: A Review of Preclinical Models and Meta-Analysis of Clinical Studies.