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

NCT ID: NCT04804943

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-22
• Study Completion Date: 2025-09-04

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).

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Patients will receive the standard and NOA-001 therapy.

Group Type: EXPERIMENTAL

NOA-001

Intervention Type: DEVICE

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.

Standard treatment group (ARDS caused by Non-COVID-19 cohort)

Patients will receive the standard therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Patients will receive the standard and NOA-001 therapy.

Group Type: EXPERIMENTAL

NOA-001

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

At Informed Consent

1. Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):

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

At Informed Consent

1. Patients tested positive for COVID-19

2. Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):

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)

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

5. 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 who are intubated and mechanically ventilated

3. Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation

Exclusion Criteria

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

(ARDS caused by 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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toray Industries, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Showa University Hospital

Tokyo, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

NOA-001 Team

Role: CONTACT

clinical-trials.toray.mb@mail.toray

+81 3 3245 8588

Other Identifiers

NOA001ARDS01

Identifier Type: -

Identifier Source: org_study_id