Anti-CD14 Treatment with IC14 in Hospitalized ARDS Patients

Launched by IMPLICIT BIOSCIENCE · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition that affects breathing. In this trial, hospitalized patients who are on mechanical ventilation will receive either an experimental drug called IC14, which targets a specific protein in the body, or a placebo (a substance with no active effect). The goal is to see how well this treatment improves patients' oxygen levels by measuring their oxygenation index over four days. Participants will be followed for a total of 28 days to monitor their progress.

To be eligible for the trial, patients must be adults (18 years or older) who have been diagnosed with ARDS within the last 48 hours and are on mechanical ventilation. They should also have specific conditions, such as a certain level of oxygen in their blood and signs of respiratory failure that can’t be explained by heart problems or too much fluid. However, patients with severe pre-existing health issues, certain infections, or specific treatments in the last month will not be included. This trial is not yet recruiting participants, but it represents an important effort to find new treatments for ARDS, which can be life-threatening.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients may be included in the study only if they meet all the following criteria:
• • 1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)
• • 1. P:F ratio \< 300
• • 2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O
• • 3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar/lung collapse, or nodules
• • 4. Respiratory failure not fully explained by cardiac failure or fluid overload
• • 5. 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
• • 2. 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:
• • 1. Significant pre-existing organ dysfunction prior to hospitalization
• • 1. Lung: Currently receiving home oxygen therapy as documented in medical record
• • 2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
• • 3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \<30 mL/min.
• • 4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \>5 times upper limit of normal
• • 5. Hematologic: Baseline platelet count \<50,000/mm3
• 2. Presence of co-existing infection, including, but not limited to:
• • 1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm3
• • 2. Active tuberculosis or a history of inadequately treated tuberculosis
• • 3. Active hepatitis B or hepatitis C viral infection
• • 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
• • 4. Receiving comfort measures only
• • 5. Requiring \>2 vasopressors
• • 6. Pregnant
• • 7. Prisoners
• • 8. History of hypersensitivity or idiosyncratic reaction to IC14
• • 9. Women who are currently breastfeeding
• • 10. Bronchoscopy safety exclusions
• • 1. P:F \<100 on 100% FiO2
• • 2. Mean pulmonary artery pressure \> 55 mmHg
• • 3. Marked cardiovascular instability (Mean arterial pressure \<55 mmHg with vasopressor support)
• • 4. Intracranial pressure ≥20 mmHg
• • 5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)
• • 6. Supported on extracorporeal membrane oxygenation
• • 7. Endotracheal tube \<6.5 mm