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Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
NCT05123755 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG AV-001 Injection
- DRUG AV-001 Placebo Injection
Study Locations (5)
California
- Hoag Memorial Hospital Presbyterian — Newport Beach
Colorado
- Denver Health Medical Center — Denver
Maryland
- MedStar Health Research Institute, Inc. — Hyattsville
Michigan
- Henry Ford Health System — Detroit
Ohio
- The Ohio State University — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05123755
The ClinicalTrials.gov registry entry for NCT05123755 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vasomune Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Pneumonia appearing as the primary indexed condition, and to 2 interventions — of which AV-001 Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05123755 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05123755 about?
NCT05123755 is a clinical study titled "Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.". 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 dai...
What is the current status of trial NCT05123755?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2021-12-20. Estimated completion is 2026-06.
What conditions does trial NCT05123755 study?
This clinical trial studies the following conditions: Pneumonia, Acute Respiratory Distress Syndrome, COVID-19 Acute Respiratory Distress Syndrome, Respiratory Infection, Pneumonia, Viral. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05123755?
The interventions under investigation include: AV-001 Injection (DRUG), AV-001 Placebo Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05123755?
This trial is sponsored by Vasomune Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05123755 being conducted?
This trial has 5 study locations across California, Colorado, Maryland, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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