RecruitingPhase 2NCT05123755

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

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.

Sponsor

Vasomune Therapeutics, Inc.

Enrollment

120 participants

Start Date

Dec 20, 2021

Study Type

INTERVENTIONAL

Conditions

Pneumonia Respiratory Infection Acute Respiratory Distress Syndrome Viral or Bacterial Infections Pneumonia, Viral COVID-19 Acute Respiratory Distress Syndrome

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AV-001 Injection and a drug called AV-001 Placebo Injection for people with acute respiratory distress syndrome, covid-19 acute respiratory distress syndrome, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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