Adjunctive Recombinant Human Plasma Gelsolin With Standard of Care for Moderate-to-Severe ARDS

What is the Purpose of this Study?

The purpose of this study is to evaluate an experimental medication called gelsolin (recombinant human plasma gelsolin) in people who have moderate to severe acute respiratory distress syndrome (ARDS) due to pneumonia or other infections. In ARDS, inflammation and damage in the lungs makes breathing difficult. The study will assess the safety and effectiveness of gelsolin when given with standard-of-care treatments the patient is already receiving versus placebo (inactive substance). Gelsolin is a naturally occurring protein that exists inside the cells and bloodstream. The gelsolin used in this study is a recombinant product, which means it is manufactured to be the same as the gelsolin that exists in the body naturally. Studies show that when people are sick with infections and/or inflammation, the amount of gelsolin in the body is reduced. If more gelsolin is injected into the body, it is possible that the lungs will have less inflammation and expedite recovery from ARDS.


Eligibility

  • 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist
  • * Investigator or designee to note radiologic findings in the electronic case report form (eCRF)
  • * Radiology report and conclusion should be summarized in the eCRF
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ADJUNCTIVE RECOMBINANT HUMAN PLASMA GELSOLIN WITH STANDARD OF CARE FOR MODERATE-TO-SEVERE ARDS DUE TO PNEUMONIA OR OTHER INFECTIONS

Study Details
Disease Type/Condition

Other

Principal Investigator

Matusov, Yuri

Age Group

Adult

Phase

II

IRB Number

STUDY00003671

ClinicalTrials.gov ID

NCT05947955

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Matusov, Yuri

Age Group

Adult

Phase

II

IRB Number

BTI-203

ClinicalTrials.gov ID

NCT05947955

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org