Pilot Study of NOA-001

JRCT ID: jRCT2032200381

Registered date:15/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ARDS (acute respiratory distress syndrome)
• Date of first enrollment: 02/03/2021
• Target sample size: 45
• Study type: Interventional

Intervention(s)

In patients assigned to control equipment and COVID groups , the investigational devices will be treated within 96 hours after initiation of mechanical ventilation.
The investigational devices will be replaced regularly (at 22 to 24 hours after the initiation of procedure), and will be continuously performed until 168 hours from the enrollment.

Outcome(s)

• Primary Outcome: Ventilator Free Days (VFD, Days alive and ventilator-free) (Day 28)

Secondary Outcome

Efficacy
1)All-cause Mortality [Time Frame: At Day 28, 60 and 90]
2)Mortality in ICU [Time Frame: Up to Day 28]
3)Mortality in Hospital [Time Frame: Up to Day 28]
4)Changes in PaO2/ FiO2 ratio
Safety
1)Adverse events
2)Device deficiency
3)Clinical examination values
4)Vital signs

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(Non-COVID-19 Cohort)
At Informed Consent
1)Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (1)-(4):
(1) Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
(2) 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
(3) Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on chest X-ray or CT scan
(4) Patients with PaO2/ FiO2 ratio <= 300 mmHg (PEEP >= 5 cmH2O)
2)Patients who are intubated and mechanically ventilated
3)Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
4)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
1)Patients with PaO2/ FiO2 ratio >= 50 mmHg and <= 200 mmHg (PEEP >= 5 cmH2O)
2)Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on CT scan within 48 hours before enrollment
3)Patients who are intubated and mechanically ventilated
4)Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation

Exclude criteria

(Non-COVID-19 Cohort)
At Informed Consent
1)Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
2)Patients who are treated with ECMO or HFOV
3)Patients with renal dialysis therapy for chronic renal failure
4)Patients with congestive heart failure (NYHA class IV)
5)Patients with acuter left ventricular failure
6)Patients with liver failure (Child-Pugh grade C)
7)Patients who have burns in excess of 15% total body surface area
8)Patients after resuscitation from cardiac arrest
9)Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)
10)Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent
11)Patients with pregnancy or lactating
12)Patients tested positive for COVID-19
At Enrollment
1)Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
2)Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment
3)Patients with platelet count <= 50,000 /mm3 by the latest blood test
4)Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment
5)Patients whose life expectancy is <= 24 hours after enrollment
6)Patients after resuscitation from cardiac arrest between informed consent and enrollment
7)Patients tested positive for COVID-19 between informed consent and enrollment

Related Information

• Primary Sponsor: Miyakawa Jun