Trial Summary
What is the purpose of this trial?Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days.
The primary outcome is the day 4 oxygenation index assessed as a continuous measure.
Eligibility Criteria
This trial is for hospitalized patients with ARDS, a severe lung condition often caused by infection or injury. Participants must meet specific health criteria to be eligible.Inclusion Criteria
My breathing issues are not due to heart problems or fluid in my body.
I can understand and sign the consent form myself or have someone who can legally do it for me.
My breathing support is set to a pressure of 5 cm H2O or more.
Exclusion Criteria
I am only receiving treatment to ease symptoms.
I need more than two medications to manage my blood pressure.
I have an active infection such as HIV, TB, hepatitis B, or C.
I do not have severe lung, heart, brain conditions, or need for significant life support that would make a lung exam unsafe.
Treatment Details
The study tests IC14, an antibody treatment against CD14 in the blood, versus a placebo. Patients are randomly assigned to one of these treatments and monitored for oxygen levels over 28 days.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IC14 (atibuclimab)Experimental Treatment1 Intervention
IC14 (atibuclimab) is a recombinant monoclonal antibody against human CD14
Group II: Identical-appearing placeboPlacebo Group1 Intervention
Sterile normal saline
Atibuclimab is already approved in United States for the following indications:
🇺🇸 Approved in United States as Atibuclimab for:
- Acute Decompensated Heart Failure (clinical trial phase, not yet approved)
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of WashingtonSeattle, WA
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Who is running the clinical trial?
Implicit BioscienceLead Sponsor
University of WashingtonCollaborator