RECRUITING

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

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Conditions

Acute Respiratory Distress SyndromeAdult Respiratory Distress SyndromeAcute Lung InjuryAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)ARDSIC14

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody (IC14) in Hospitalized Patients With Acute Respiratory Distress Syndrome

Quick Facts

Study Start:2025-08-15
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06513949

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)
  2. 1. P:F ratio \< 300
  3. 2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O
  4. 3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar/lung collapse, or nodules
  5. 4. Respiratory failure not fully explained by cardiac failure or fluid overload
  6. 5. Within 1 week of known clinical insult or new or worsening respiratory symptoms
  7. 2. Patient or Legal authorized representative able to understand and give written informed consent
  1. 1. Significant pre-existing organ dysfunction prior to hospitalization
  2. 1. Lung: Currently receiving home oxygen therapy as documented in medical record
  3. 2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
  4. 3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \<30 mL/min.
  5. 4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \>5 times upper limit of normal
  6. 5. Hematologic: Baseline platelet count \<50,000/mm3
  7. 2. Presence of co-existing infection, including, but not limited to:
  8. 1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm3
  9. 2. Active tuberculosis or a history of inadequately treated tuberculosis
  10. 3. Active hepatitis B or hepatitis C viral infection
  11. 3. Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments
  12. 4. Receiving comfort measures only
  13. 5. Requiring \>2 vasopressors
  14. 6. Pregnant
  15. 7. Prisoners
  16. 8. History of hypersensitivity or idiosyncratic reaction to IC14
  17. 9. Women who are currently breastfeeding
  18. 10. Bronchoscopy safety exclusions
  19. 1. P:F \<100 on 100% FiO2
  20. 2. Mean pulmonary artery pressure \> 55 mmHg
  21. 3. Marked cardiovascular instability (Mean arterial pressure \<55 mmHg with vasopressor support)
  22. 4. Intracranial pressure ≥20 mmHg
  23. 5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)
  24. 6. Supported on extracorporeal membrane oxygenation
  25. 7. Endotracheal tube \<6.5 mm

Contacts and Locations

Study Contact

Linzee Mabrey, MD, MSc
CONTACT
(206) 897-5051
mflinzee@uw.edu

Principal Investigator

Linzee Mabrey, MD, MsC
PRINCIPAL_INVESTIGATOR
Unversity of Washington

Study Locations (Sites)

Harborview Medical Center
Seattle, Washington, 98104
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Implicit Bioscience

  • Linzee Mabrey, MD, MsC, PRINCIPAL_INVESTIGATOR, Unversity of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • ARDS
  • IC14

Additional Relevant MeSH Terms

  • Acute Respiratory Distress Syndrome
  • Adult Respiratory Distress Syndrome
  • Acute Lung Injury
  • Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)