Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Promising ARDS drug trial pulled before it even started

NCT ID NCT03017547

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the trial was withdrawn before enrolling anyone, so no data was collected.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The trial was withdrawn before any patients were enrolled, so no results are available.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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute respiratory distress syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.