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

NCT04804943 | Recruiting

• 1 other identifier: NOA001ARDS01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Respiratory Distress Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-cause Mortality

  Up to Day 28, 60 and 90

• Mortality in ICU

  Up to Day 28

• Mortality in Hospital

  Up to Day 28

• Changes in PaO2/ FiO2 ratio

  Up to Day 28

Study Arms (3)

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

EXPERIMENTAL

Patients will receive the standard and NOA-001 therapy.

Device: NOA-001

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

NO INTERVENTION

Patients will receive the standard therapy.

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

EXPERIMENTAL

Patients will receive the standard and NOA-001 therapy.

Device: NOA-001

Interventions

NOA-001 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.

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 96 hours after initiation of mechanical ventilation
• 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 96 hours after initiation of mechanical ventilation

You may not qualify if:

• At Informed Consent
• 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

Sponsors & Collaborators

• Toray Industries, Inc: lead

Study Sites (1)

Showa University Hospital

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Central Study Contacts

NOA-001 Team

CONTACT

+81 3 3245 8588; clinical-trials.toray.mb@mail.toray

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: May 22, 2021
• Primary Completion: June 30, 2025
• Study Completion: September 4, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

JP (1)