Recruiting
Phase 2

Observational Study

Sponsor:

Vasomune Therapeutics, Inc.

Code:

NCT05123755

Conditions

Acute Respiratory Distress Syndrome

Viral or Bacterial Infections

Pneumonia

Pneumonia, Viral

Respiratory Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AV-001 Injection

AV-001 Placebo Injection

Study Details

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

Study ID

NCT05123755

Start date

Dec 20, 2021

Status verified date

Sep, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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.

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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).

Interventions

AV-001 Injection

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

AV-001 Placebo Injection

D-PBS

Primary outcome measure

  • 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. [ Time Frame: Up to Day 60 ]

Central Contacts and Locations

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92658-6100

Contacts

Laurie Hendricks, MSN, RN, OCN

949-764-5987laurie.hendricks@hoag.org

Denver Health Medical Center

Recruiting

Denver, Colorado, United States, 80203

Contacts

Terra Hiller, BSN, RN

303-602-7046terra.hiller@dhha.org

MedStar Health Research Institute, Inc.

Recruiting

Hyattsville, Maryland, United States, 20782

Contacts

Terry Moriarty, MSN, RN, CCRN

202-877-3657Theresa.m.moriarty@medstar.net

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Tina M Daniels, MSN, RN

313-916-2361tdaniel9@hfhs.org

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Michael Hill, BSN, RN, CCRP

614-293-6185michael.hill@osumc.edu

More Information

Sponsor

Vasomune Therapeutics, Inc.

Last update posted

Feb 27, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vasomune Therapeutics, Inc. on 2026-02-27.