Acute Respiratory Distress Syndrome
Conditions
Brief summary
Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.
Detailed description
Up to 160 patients with ARDS will be randomized to receive either IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 or placebo for 4 days beginning within 48 hours of meeting inclusion criteria. Study participation will be for 28 days.
Interventions
DRUGIC14
Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS
OTHERPlacebo
sterile normal saline for infusion
Sponsors
Implicit Bioscience
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. ICU admission 2. Age 18-70 years 3. Presence of a known ARDS clinical risk within 7 days of onset: 1. Pneumonia 2. Sepsis 3. Trauma 4. Aspiration 5. Pancreatitis 4. Presence of ARDS (per Berlin criteria) defined as follows: 1. Acute onset (\<48 hours) 2. PaO2/FiO2\<300 on PEEP≥5 3. Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules. 4. Requirement for positive pressure ventilation via endotracheal tube 5. Anticipated duration of mechanical ventilation \>48 hrs
Exclusion criteria
1. Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry 2. Intubation for cardiopulmonary arrest 3. Do-not-attempt resuscitation (DNAR) status 4. Intubation for status asthmaticus, pulmonary embolus, myocardial infarction 5. Anticipated survival \<48 hours from intubation 6. Anticipated survival \<28 days due to pre-existing medical condition 7. Significant pre-existing organ dysfunction 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: Chronic renal failure requiring renal replacement therapy 4. Liver: Severe chronic liver disease defined as Child-Pugh Class C 8. Pre-existing, ongoing immunosuppression 1. Solid organ transplant recipient 2. Chronic high-dose corticosteroids (equivalent to \>20 mg/prednisone/day for \>14 days in the last 30 days) 3. Oncolytic drug therapy within the past 14 days 4. Known HIV positive with CD4 count \<200 cells/mm3 9. Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept) 10. Pregnancy 11. History of hypersensitivity or idiosyncratic reaction to IC14 12. Deprivation of freedom by administrative or court order
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 28 days | Treatment-emergent adverse events |
| Ventilator-free days | 28 days | The number of days alive and free of mechanical ventilation through Day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ARDS biologic markers. | 28 days | * Change in plasma IL-8, sTNFR1, IL-6 from Day 0 to Day 4 * Change in alveolar neutrophils and total protein from Day 0 to Day 4 |
Outcome results
None listed