Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05123755
PHASE2

Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.

Sponsor: Vasomune Therapeutics, Inc.

View on ClinicalTrials.gov

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).

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-12-20

Completion Date

2026-06

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

AV-001 Injection

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

DRUG

AV-001 Placebo Injection

D-PBS

Locations (5)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Denver Health Medical Center

Denver, Colorado, United States

MedStar Health Research Institute, Inc.

Hyattsville, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

The Ohio State University

Columbus, Ohio, United States