College of Medicine Jacksonville - Clinical Research Department

Jennifer Bowman

University of Florida

condition

Acute Lung Injury

Bacterial Infections

COVID-19

Communicable Diseases

Infections

Newborn Respiratory Distress Syndrome

Pneumonia

Respiratory Distress Syndrome

Respiratory Tract Infections

Syndrome

Viral Pneumonia

allSponsorName

Vasomune Therapeutics

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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).

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

University of Florida | College of Medicine Jacksonville - Clinical Research Department

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

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