Promising ARDS drug trial pulled before it even started
NCT ID NCT03017547
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to test whether IC14, a drug that blocks a key inflammatory signal, could help people with acute respiratory distress syndrome (ARDS). The plan was to give IC14 or a placebo to about 100 ICU patients and see if it reduced time on a ventilator. However, the trial was withdrawn before enrolling anyone, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IC14 (a monoclonal antibody that blocks CD14 signaling)
- What this could lead to
- If it had worked, this could have pointed toward a new treatment for ARDS by reducing inflammation in the lungs.
- What could go wrong
- The trial was withdrawn before any patients were enrolled, so no results are available. Early-phase studies often fail to show benefit in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
Jun 2019
An estimate. Start dates often move.
- Expected to finish
-
Jun 2020
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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