NCT06513949 Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
| NCT ID | NCT06513949 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Implicit Bioscience |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 56 participants in total. It began in 2026-06-17 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Linzee Mabrey, MD, MsC
PRINCIPAL INVESTIGATOR
Unversity of Washington
Frequently Asked Questions
Who can join the NCT06513949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06513949 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06513949 currently recruiting?
Yes, NCT06513949 is actively recruiting participants. Contact the research team at mflinzee@uw.edu for enrollment information.
Where is the NCT06513949 trial being conducted?
This trial is being conducted at Seattle, United States, Seattle, United States.
Who is sponsoring the NCT06513949 clinical trial?
NCT06513949 is sponsored by Implicit Bioscience. The principal investigator is Linzee Mabrey, MD, MsC at Unversity of Washington. The trial plans to enroll 56 participants.