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NCT05123755 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
A Phase 2 study of Pneumonia and Acute Respiratory Distress Syndrome, sponsored by Vasomune Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 5
- Study locations
NCT05123755: Recruiting Phase 2 study of Pneumonia and Acute Respiratory Distress Syndrome, sponsored by Vasomune Therapeutics.
NCT05123755 is a Phase 2 study of Pneumonia and Acute Respiratory Distress Syndrome that is actively recruiting participants, run by Vasomune Therapeutics. The registered enrollment target is 120 participants, below the 4,517-participant average among 47 other Pneumonia trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05123755, a Phase 2 study of Pneumonia and Acute Respiratory Distress Syndrome, is actively recruiting participants, sponsored by Vasomune Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 5
- Study locations
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).
Primary Outcome
* 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)
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 |
What NCT05123755 shows while recruiting
NCT05123755 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 4,517-participant average among 47 other Pneumonia trials with a reported enrollment target (97% lower).
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.
NCT05123755 lists 5 locations in 5 states (California, Colorado, Maryland).
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.
What interventions are being tested in trial NCT05123755?
The interventions under investigation include: AV-001 Injection (DRUG), AV-001 Placebo Injection (DRUG).
Who is sponsoring clinical trial NCT05123755?
This trial is sponsored by Vasomune Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05123755's enrollment target sits among peer trials
120 29th of 47 higher than 19 of 47 other Pneumonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pneumonia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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