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

NCT05123755 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: AV001-004CDMRP-PR203503
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  * Number of patients with any serious adverse event (SAE) (day 1 to 60/EOS) * Number of patients with any treatment emergent adverse event (TEAE) (day 1 to 60/EOS) AE assessments (day 1 to 60/EOS)

  Up to Day 60

Secondary Outcomes (12)

• 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

  Up to Day 28

• 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

  Up to Day 28

• 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

  Up to Day 28

• 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

  Up to Day 28

• 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

  Up to Day 28

Other Outcomes (18)

• 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

  Up to Day 60

• 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

  Up to Day 14

• 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

  Up to Day 14

Study Arms (2)

AV-001 Injection with standard of care (SOC).

ACTIVE COMPARATOR

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.

Drug: AV-001 Injection

AV-001 Placebo Injection with standard of care (SOC).

PLACEBO COMPARATOR

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).

Drug: AV-001 Placebo Injection

Interventions

AV-001 Injection DRUG

AV-001 (mpaBr) Cl for Injection 2.5 mg/mL

AV-001 Injection with standard of care (SOC).

AV-001 Placebo Injection DRUG

D-PBS

AV-001 Placebo Injection with standard of care (SOC).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vasomune Therapeutics, Inc.: lead

Study Sites (5)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658-6100, United States

RECRUITING

Denver Health Medical Center

Denver, Colorado, 80203, United States

RECRUITING

MedStar Health Research Institute, Inc.

Hyattsville, Maryland, 20782, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bacterial Infections; Pneumonia; Pneumonia, Viral; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Bacterial Infections and Mycoses; Infections; Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, placebo-controlled study. All sponsor, vendor and site study staff will be blinded to treatment assignment, with the exception of the unblinded biostatistician, unblinded site pharmacist, and unblinded site monitor.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized (1:1 ratio) placebo controlled trial.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 17, 2021
• Study Start: December 20, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)