Status:
RECRUITING
Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)
Lead Sponsor:
Toray Industries, Inc
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
16+ years
Phase:
NA
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 en...
Eligibility Criteria
Inclusion
- (ARDS caused by Non-COVID-19 cohort)
- 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
- Patients with PaO2/ FiO2 ratio ≥ 50 mmHg and ≤ 200 mmHg (PEEP ≥ 5 cmH2O)
- Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on CT scan within 48 hours before enrollment
- Patients who are intubated and mechanically ventilated
- Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
Exclusion
- 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)
- Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent
- Patients with pregnancy or lactating
- Patients tested positive for COVID-19
- At Enrollment
- Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment
- Patients with platelet count ≤ 50,000 /mm3 by the latest blood test
- Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment
- Patients whose life expectancy is ≤ 24 hours after enrollment
- Patients after resuscitation from cardiac arrest between informed consent and enrollment
- Patients tested positive for COVID-19 between informed consent and enrollment
- (ARDS caused by COVID-19 cohort)
- Inclusion Criteria:
- At Informed Consent
- Patients tested positive for COVID-19
- 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
- Patients with PaO2/ FiO2 ratio ≥ 50 mmHg and ≤ 200 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
Key Trial Info
Start Date :
May 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 4 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04804943
Start Date
May 22 2021
End Date
September 4 2025
Last Update
July 9 2024
Active Locations (1)
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1
Showa University Hospital
Tokyo, Japan