WithdrawnPhase 2

A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Stopped: withdrawn, not enrolling

0Started 2019-06

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. ICU admission
✓. Age 18-70 years
✓. Presence of a known ARDS clinical risk within 7 days of onset:
✓. Pneumonia
✓. Sepsis
✓. Trauma
✓. Aspiration
✓. Pancreatitis

Exclusion criteria

✕. 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

What they're measuring

Safety

Timeframe: 28 days

Ventilator-free days

Timeframe: 28 days

Trial details

NCT IDNCT03017547

SponsorImplicit Bioscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials