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.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
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Full eligibility criteria for NCT03017547
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age 18-70 years
Presence of a known ARDS clinical risk within 7 days of onset:
Presence of ARDS (per Berlin criteria) defined as follows:
Acute onset (<48 hours)
PaO2/FiO2<300 on PEEP≥5
Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules.
Requirement for positive pressure ventilation via endotracheal tube
Anticipated duration of mechanical ventilation >48 hrs
Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
Intubation for cardiopulmonary arrest
Do-not-attempt resuscitation (DNAR) status
Intubation for status asthmaticus, pulmonary embolus, myocardial infarction
Anticipated survival <48 hours from intubation
Anticipated survival <28 days due to pre-existing medical condition
Significant pre-existing organ dysfunction
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
Liver: Severe chronic liver disease defined as Child-Pugh Class C
Pre-existing, ongoing immunosuppression
Solid organ transplant recipient
Chronic high-dose corticosteroids (equivalent to >20 mg/prednisone/day for >14 days in the last 30 days)
Oncolytic drug therapy within the past 14 days
Known HIV positive with CD4 count <200 cells/mm3
Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira®
(adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept)
History of hypersensitivity or idiosyncratic reaction to IC14
Deprivation of freedom by administrative or court order
All locations for NCT03017547
View full eligibility
Tris trial is registered with FDA with number: NCT03017547. The sponsor of the trial is Implicit Bioscience and it is looking for 0 volunteers for the current phase.
Official trial title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome
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