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

• ClinicalTrials.gov Identifier: NCT04804943
• Recruitment Status: Recruiting
• First Posted: March 18, 2021
• Last Update Posted: May 27, 2021
• Sponsor: Toray Industries, Inc
• Information provided by (Responsible Party): Toray Industries, Inc

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	Not Applicable

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 (Clinical Trial)
• Estimated 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
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: October 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.

Outcome Measures

Primary Outcome Measures :

1. Ventilator Free Days (VFD, Days alive and ventilator-free) [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

(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

Contacts and Locations

Contacts

Contact: NOA-001 Team; +81 3 3245 8588; clinical-trials.toray.mb@mail.toray

Locations

Japan

Showa University Hospital; Recruiting

Tokyo, Japan

Sponsors and Collaborators

Toray Industries, Inc

More Information

• Responsible Party: Toray Industries, Inc
• ClinicalTrials.gov Identifier: NCT04804943
• Other Study ID Numbers: NOA001ARDS01
• First Posted: March 18, 2021
• Last Update Posted: May 27, 2021
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Toray Industries, Inc:

COVID-19; Diffuse Alveolar Damage; DAD; Acute Respiratory Distress Syndrome; ARDS; NOA-001; Hemoperfusion

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury