A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

• Status: Withdrawn
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Implicit Bioscience

Criteria

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