Pilot Clinical Study to Investigate the Efficacy and Safety of NOA-001 for the Treatment of Patients With Acute Respiratory Distress Syndrome.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Respiratory Distress Syndrome
- Sponsor
- Toray Industries, Inc
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Ventilator Free Days (VFD, Days alive and ventilator-free)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Detailed Description
(ARDS caused by Non-COVID-19 cohort): The objectives of this clinical study is to investigate the efficacy and safety of NOA-001 in patients with ARDS caused by Non-COVID-19. The number of patients enrolled is 30 (20 patients in the NOA-001 group and 10 patients in the standard therapy group). (ARDS caused by COVID-19 cohort): The objectives of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS caused by COVID-19. The number of patients enrolled is 15 (in the NOA-001 group only).
Investigators
Eligibility Criteria
Inclusion Criteria
- •At Informed Consent
- •Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):
- •Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
- •Patients with respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e. g., echo-cardiography) to exclude hydrostatic edema if no risk factor present
- •Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on chest X-ray or CT scan
- •Patients with PaO2/ FiO2 ratio ≤ 300 mmHg (PEEP ≥ 5 cmH2O)
- •Patients who are intubated and mechanically ventilated
- •Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
- •Patients aged ≥ 16 years at informed consent (Signed informed consent form from legally acceptable representative must be available if patient is aged \< 20 years)
- •At Enrollment
Exclusion Criteria
- •At Informed Consent
- •Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- •Patients who are treated with ECMO or HFOV
- •Patients with renal dialysis therapy for chronic renal failure
- •Patients with congestive heart failure (NYHA class IV)
- •Patients with acuter left ventricular failure
- •Patients with liver failure (Child-Pugh grade C)
- •Patients who have burns in excess of 15% total body surface area
- •Patients after resuscitation from cardiac arrest
- •Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)
Outcomes
Primary Outcomes
Ventilator Free Days (VFD, Days alive and ventilator-free)
Time Frame: Day 28
VFD is a composite measure of all-cause mortality and the number of days free of mechanical ventilation (VFD) within 28 days.
Secondary Outcomes
- All-cause Mortality(Up to Day 28, 60 and 90)
- Mortality in ICU(Up to Day 28)
- Mortality in Hospital(Up to Day 28)
- Changes in PaO2/ FiO2 ratio(Up to Day 28)