Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)

Sponsor

Toray Industries, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04804943

Collaborator

(none)

Enrollment

Location

Arms

17.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Device: NOA-001	N/A

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 5 (in the NOA-001 group only).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Clinical Study to Investigate the Efficacy and Safety of NOA-001 for the Treatment of Patients With Acute Respiratory Distress Syndrome.

Actual Study Start Date :

May 22, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NOA-001 group (ARDS caused by Non-COVID-19 cohort) Patients will receive the standard and NOA-001 therapy.	Device: NOA-001 NOA-001 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.
No Intervention: Standard treatment group (ARDS caused by Non-COVID-19 cohort) Patients will receive the standard therapy.
Experimental: NOA-001 group (ARDS caused by COVID-19 cohort) Patients will receive the standard and NOA-001 therapy.	Device: NOA-001 NOA-001 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.

Arm

Intervention/Treatment

Experimental: NOA-001 group (ARDS caused by Non-COVID-19 cohort)

Patients will receive the standard and NOA-001 therapy.

Device: NOA-001

NOA-001 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.

No Intervention: Standard treatment group (ARDS caused by Non-COVID-19 cohort)

Patients will receive the standard therapy.

Experimental: NOA-001 group (ARDS caused by COVID-19 cohort)

Patients will receive the standard and NOA-001 therapy.

Device: NOA-001

NOA-001 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 Measures

Primary Outcome Measures

Ventilator Free Days (VFD, Days alive and ventilator-free) [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 Outcome Measures

All-cause Mortality [Up to Day 28, 60 and 90]
Fatalities, mortality all-causes
Mortality in ICU [Up to Day 28]
All-cause mortality for patients who died in Intensive Care Units.
Mortality in Hospital [Up to Day 28]
The number of patients who died in hospital
Changes in PaO2/ FiO2 ratio [Up to Day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

(ARDS caused by Non-COVID-19 cohort)

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 48 hours after ARDS diagnosis confirmed by Berlin definition
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 48 hours after ARDS diagnosis confirmed by Berlin definition

Exclusion Criteria:

At Informed Consent

Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis confirmed by Berlin definition
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 48 hours after ARDS diagnosis confirmed by Berlin definition
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 48 hours after ARDS diagnosis confirmed by Berlin definition

Exclusion Criteria:

At Informed Consent

Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis confirmed by Berlin definition
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

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