Investigating NOA-001 for treating 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.

This study is testing a new treatment called NOA-001 to see if it can help people with Acute Respiratory Distress Syndrome, including those affected by COVID-19.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Toray Industries, Inc (industry)
• Locations: 1 site (Tokyo)
• Trial ID: NCT04804943 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the efficacy and safety of NOA-001 in patients suffering from Acute Respiratory Distress Syndrome (ARDS), including those caused by COVID-19 and non-COVID-19 factors. The study will enroll a total of 45 patients, with 30 in the non-COVID-19 cohort receiving either NOA-001 or standard therapy, and 15 patients in the COVID-19 cohort receiving NOA-001 only. Participants must meet specific diagnostic criteria for ARDS and be intubated and mechanically ventilated. The study will assess outcomes within a defined timeframe after initiation of mechanical ventilation.

Who should consider this trial

Good fit: Ideal candidates include patients aged 16 and older who are intubated and mechanically ventilated due to ARDS within 7 days of symptom onset.

Not a fit: Patients with ARDS not requiring mechanical ventilation or those with ARDS caused by factors other than COVID-19 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with ARDS, potentially improving survival and recovery rates.

How similar studies have performed: While there have been studies on ARDS treatments, the specific approach using NOA-001 is novel and has not been extensively tested in this context.

Eligibility 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 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

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)

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 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

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

Where this trial is running

Tokyo

• Showa University Hospital — Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: NOA-001 Team

Conditions: Acute Respiratory Distress Syndrome, COVID-19, Diffuse Alveolar Damage, DAD, ARDS, NOA-001, Hemoperfusion