Table 2.
Ongoing/planned clinical trials in ARDS
| Study reference number | Study title and abbreviation | Design | Population A) Timing B) P/F ratio | Anticipated enrollment | Intervention | Primary outcome | Status |
|---|---|---|---|---|---|---|---|
|
NCT01731795 |
Efficacy Study of Dexamethasone to Treat the Acute Respiratory Distress Syndrome (DEXA-ARDS) |
Phase 2/3 RCT |
A) 24 hours from ARDS onset B) <200 |
314 |
Dexamethasone (20 mg/day for five days, then 10 mg/day for five days) |
Ventilator-free days |
Not yet recruiting |
|
NCT01284452 |
Efficacy of hydrocortisone in treatment of severe sepsis/septic shock patients with ALI/ARDS |
Phase 2/3 RCT |
A) 12 hours from organ dysfunction B) <300 |
194 |
Hydrocortisone 50 mg every six hours for seven days |
28-day all-cause mortality |
Recruiting |
|
ISRCTN88244364 |
Simvastatin in acute lung injury (HARP-2) [20] |
Phase 2/3 RCT |
A) 48 hours from ALI onset B) <300 |
540 |
Simvastatin 80 mg daily |
Ventilator-free days |
Recruiting |
|
NCT00979121 |
Statins for Acutely Injured Lungs from Sepsis (SAILS) |
Phase 3 RCT |
A) 48 hours from ALI onset B) <300 |
1000 |
Rosuvastatin 20 mg daily |
Hospital mortality Day 60 |
Recruiting |
|
ACTRN12612000418875 |
Nebulized heparin for lung injury |
Phase 2 RCT |
A) Within 24 hours of mechanical ventilation in at-risk patients B) <300 |
256 |
Nebulised Heparin 25,000 international units, every six hours for up to 10 days |
Physical function assessed using physical function component of SF-36 health survey |
Not yet recruiting |
|
NCT01659307 |
The effect of Aspirin on REducing iNflammation in human in vivo model of Acute lung injury (ARENA) |
Phase 2 RCT |
Healthy, non-smoking adults, using an LPS model of ALI |
33 |
Aspirin 75 mg or Aspirin 1,200 mg |
Bronchalveolar lavage intraleukin-8 concentration |
Not yet recruiting |
|
NCT01504867 |
LIPS-A: Lung Injury Prevention Study with Aspirin |
Phase 2 RCT |
Adults admitted to hospital via the emergency department at high-risk of developing ALI |
400 |
Aspirin 325 mg Day 1, then 81 mg daily days 2to 7 |
Development of ARDS |
Recruiting |
|
ISRCTN95690673 |
Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction (KARE) [28] |
Phase 2 RCT |
A) 48 hours from ALI onset B) <300 |
60 |
Palifermin 60 μg/kg IV daily for up to six days |
Oxygenation index at Day 7 |
Recruiting |
|
ISRCTN27673620 |
VItamiN D Replacement to Prevent Acute Lung Injury following OesophagectOmy (VINDALOO) [34] |
Phase 1/2 RCT |
Adults undergoing planned transthoracic esophagectomy |
80 |
Oral Vitamin D (100,000 IU) |
EVLW at end of procedure |
Recruiting |
| NCT00789685 | Safety, tolerability and preliminary efficacy of FP-1201 in ALI and ARDS | Phase 1/2 Non-randomized | A) 48 hours from ALI onset B) <300 | 37 | Interferon-β, increasing dose over six days | Clinically significant treatment emergent events, and all-cause mortality | Completed |