Menu
Recruiting NCT06513949

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

Phase II Interventional Acute Respiratory Distress Syndrome Adult Respiratory Distress Syndrome Acute Lung Injury Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atibuclimab, Placebo.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

This is a 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 (ARDS). CD14 is a key mediator in recognition of molecular markers of tissue damage (damage-associated molecular patterns, DAMPs) and infection (pathogen-associated molecular patterns, PAMPS).

The primary objective of the study is to determine the efficacy of IC14 in patients hospitalized with ARDS for reducing the severity of lung injury as measured by the day 4 Oxygenation Index (OI) assessed as a continuous measure (mean airway pressure x fraction of inspired oxygen \[FiO2\] x 100/partial pressure of oxygen \[PaO2\]). OI captures severity of hypoxemia and concurrent intensity of ventilatory support.

Secondary objectives include determining whether IC14 reduces the systemic and alveolar inflammatory response, and improves indices of oxygenation and illness severity. Exploratory endpoints include determining the effect of CD14 blockade on duration of mechanical ventilation and mortality in patients hospitalized with ARDS. Pharmacokinetic \[PK\]/Pharmacodynamic \[PD\] endpoints include determining day 4 IC14 levels in bronchoalveolar fluid (BALF) vs. serum, and determining the feasibility of measuring blood presepsin levels, a CD14-pathway specific biomarker for rapid assessment.

Interventions

  • Biological Atibuclimab
    monoclonal antibody against human CD14
  • Other Placebo
    Sterile normal saline for injection

Primary outcome measures

  • Day 4 Oxygenation Index [Time frame: Day 1 through Day 4]
Secondary outcome measures (12)
  • Biomarkers of injury and inflammation measured in bronchoalveolar lavage fluid [Time frame: Day 4]
  • Biomarkers of injury and inflammation measured in plasma [Time frame: Day 4]
  • Oxygenation index [Time frame: Days 7 and 14]
  • Oxygen saturation index [Time frame: Days 4, 7, and 14]
  • P:F ratio [Time frame: Days 4, 7, and 14]
  • S:F ratio [Time frame: Days 4, 7, and 14]
  • Sequential Organ Failure Assessment (SOFA) Score (range 0 [best] to 24 [worst]) [Time frame: Days 4, 7, and 14]
  • Time to blood presepsin level [Time frame: Days 0-4]
  • Cumulative incidence of run failures [Time frame: Days 0-1]
  • Cumulative incidence of protocol-specified exempt serious events [Time frame: Days 1-28]
  • Cumulative incidence of grade 3 and 4 clinical and laboratory adverse events [Time frame: Days 1-28]
  • Cumulative incidence of serious adverse events [Time frame: Days 1-28]

Eligibility criteria

Inclusion criteria

Patients may be included in the study only if they meet all the following criteria:

  • Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)
  • P:F ratio < 300
  • Positive end-expiratory pressure (PEEP) ≥5 cm H2O
  • Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar/lung collapse, or nodules
  • Respiratory failure not fully explained by cardiac failure or fluid overload
  • Within 1 week of known clinical insult or new or worsening respiratory symptoms

i. Common Risk Factors for ARDS: Pneumonia, aspiration, inhalation injury, pulmonary contusion, pulmonary vasculitis, drowning, non-pulmonary sepsis, major trauma, pancreatitis, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions

  • Patient or Legal authorized representative able to understand and give written informed consent

Exclusion criteria

An individual fulfilling any of the following criteria should be excluded from enrollment in the study:

  • Significant pre-existing organ dysfunction prior to hospitalization
  • Lung: Currently receiving home oxygen therapy as documented in medical record
  • Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record
  • Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) <30 mL/min.
  • Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases >5 times upper limit of normal
  • Hematologic: Baseline platelet count <50,000/mm3
  • Presence of co-existing infection, including, but not limited to:
  • HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm3
  • Active tuberculosis or a history of inadequately treated tuberculosis
  • Active hepatitis B or hepatitis C viral infection
  • 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
  • Receiving comfort measures only
  • Requiring >2 vasopressors
  • Pregnant
  • Prisoners
  • History of hypersensitivity or idiosyncratic reaction to IC14
  • Women who are currently breastfeeding
  • Bronchoscopy safety exclusions
  • P:F <100 on 100% FiO2
  • Mean pulmonary artery pressure > 55 mmHg
  • Marked cardiovascular instability (Mean arterial pressure <55 mmHg with vasopressor support)
  • Intracranial pressure ≥20 mmHg
  • Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)
  • Supported on extracorporeal membrane oxygenation
  • Endotracheal tube <6.5 mm

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Harborview Medical Center — Seattle
  • University of Washington — Seattle

Identifiers

NCT: NCT06513949 · ARDS01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗