Actively Recruiting
Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)
Led by Toray Industries, Inc · Updated on 2024-07-09
45
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary object of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS (ARDS caused by Non-COVID-19 or COVID-19).
CONDITIONS
Official Title
Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 years or older (signed consent required from a legal representative if under 20 years)
- Patients diagnosed with ARDS according to the Berlin definition with acute onset within 7 days
- Patients with respiratory failure not fully explained by heart failure or fluid overload
- Patients with bilateral lung opacities not explained by other causes on X-ray or CT scan
- Patients with a PaO2/FiO2 ratio of 50 to 300 mmHg under positive end-expiratory pressure (PEEP 5 cmH2O)
- Patients who are intubated and mechanically ventilated
- Patients who can be enrolled within 96 hours after starting mechanical ventilation
You will not qualify if you...
- Patients unlikely to be weaned from mechanical ventilation
- Patients treated with ECMO or high-frequency oscillatory ventilation (HFOV)
- Patients on chronic renal dialysis
- Patients with severe congestive heart failure (NYHA class IV)
- Patients with acute left ventricular failure
- Patients with severe liver failure (Child-Pugh grade C)
- Patients with burns covering more than 15% of total body surface area
- Patients recently resuscitated from cardiac arrest
- Patients with known hypersensitivity to heparin or nafamostat mesylate
- Patients who received blood purification therapy with cytokine adsorbing devices or endotoxin removal within 7 days before consent
- Pregnant or breastfeeding patients
- Patients who tested positive for COVID-19 (for non-COVID-19 ARDS group at consent and enrollment)
- Patients with platelet count less than or equal to 50,000/mm3 at enrollment
- Patients expected to live 24 hours or less after enrollment
- Patients who received specific blood purification therapies between consent and enrollment
- Patients who had cardiac arrest after consent and before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Showa University Hospital
Tokyo, Japan
Actively Recruiting
Research Team
N
NOA-001 Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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