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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 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.
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).
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,517-participant average among 47 other Pneumonia trials with a reported enrollment target (97% lower). The listed sponsor is Vasomune Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Related
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