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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: NOA-001

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).

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: NOA-001 Team; Phone Number: +81 3 3245 8588; Email: clinical-trials.toray.mb@mail.toray

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Showa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

(ARDS caused by Non-COVID-19 cohort)

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

Exclusion Criteria:

At Informed Consent

1. Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis confirmed by Berlin definition
2. Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
3. Patients who are treated with ECMO or HFOV
4. Patients with renal dialysis therapy for chronic renal failure
5. Patients with congestive heart failure (NYHA class IV)
6. Patients with acuter left ventricular failure
7. Patients with liver failure (Child-Pugh grade C)
8. Patients who have burns in excess of 15% total body surface area
9. Patients after resuscitation from cardiac arrest
10. Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)
11. Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent
12. Patients with pregnancy or lactating
13. 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)

Inclusion Criteria:

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

Exclusion Criteria:

At Informed Consent

1. Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis confirmed by Berlin definition
2. Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
3. Patients who are treated with ECMO or HFOV
4. Patients with renal dialysis therapy for chronic renal failure
5. Patients with congestive heart failure (NYHA class IV)
6. Patients with acuter left ventricular failure
7. Patients with liver failure (Child-Pugh grade C)
8. Patients who have burns in excess of 15% total body surface area
9. Patients after resuscitation from cardiac arrest
10. Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)
11. Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent
12. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator Free Days (VFD, Days alive and ventilator-free)	VFD is a composite measure of all-cause mortality and the number of days free of mechanical ventilation (VFD) within 28 days.	Day 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Toray Industries, Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 4, 2024

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hemoperfusion; COVID-19; ARDS; Acute Respiratory Distress Syndrome; DAD; Diffuse Alveolar Damage; NOA-001
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: NOA001ARDS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No