Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Public ClinicalTrials.gov record NCT05123755. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Phase 2a Multiple Ascending Dose Study to Examine the Safety, Tolerability and Efficacy of AV-001 Injection in Patients Hospitalized With Pneumonia Due To COVID-19 or Other Respiratory Infections.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 60 eligible patients (20 patients in each of cohort 1, 2 and 3) 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).
Study identification
- NCT ID
- NCT05123755
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 20, 2021 (Actual)
- Primary completion
- Sep 2026 (Estimated)
- Completion
- Sep 2026 (Estimated)
- Last update posted
- Sep 29, 2026
2021 – 2026
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658-6100 | — |
| Denver Health Medical Center | Denver | Colorado | 80203 | — |
| Northwestern University Medical Center | Chicago | Illinois | 60611 | — |
| MedStar Health Research Institute, Inc. | Hyattsville | Maryland | 20782 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05123755, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05123755 live on ClinicalTrials.gov.