Acute Respiratory Distress SyndromeNCT04804943
Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)
A study testing NOA-001 in people with Acute Respiratory Distress Syndrome, run by Toray Industries, Inc at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- NOA-001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteJapan
- Study dates
- 22 May 2021to 4 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
- At Informed Consent
- Patients tested positive for COVID-19
- 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 who are intubated and mechanically ventilated
- Patients who can be enrolled in the study within 96 hours after initiation of mechanical ventilation
Who cannot join
- 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
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- 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
- Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment
- Patients with platelet count ≤ 50,000 /mm3 by the latest blood test
- Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment
- Patients whose life expectancy is ≤ 24 hours after enrollment
- Patients after resuscitation from cardiac arrest between informed consent and enrollment
- Patients tested positive for COVID-19 between informed consent and enrollment
- (ARDS caused by COVID-19 cohort)
- 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
- At Enrollment
- Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment
- Patients with platelet count ≤ 50,000 /mm3 by the latest blood test
- Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment
- Patients whose life expectancy is ≤ 24 hours after enrollment
- Patients after resuscitation from cardiac arrest between informed consent and enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Being tested
- NOA-001
- Keywords
- COVID-19, Diffuse Alveolar Damage, DAD, Acute Respiratory Distress Syndrome, ARDS, NOA-001, Hemoperfusion
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOA-001Device
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.
| Study group | Role | What they receive |
|---|---|---|
| NOA-001 group (ARDS caused by Non-COVID-19 cohort) | Experimental | Patients will receive the standard and NOA-001 therapy. Receives: 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. Receives: Device: NOA-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (4)
All-cause Mortality
Fatalities, mortality all-causes
Measured: Up to Day 28, 60 and 90
Mortality in ICU
All-cause mortality for patients who died in Intensive Care Units.
Measured: Up to Day 28
Mortality in Hospital
The number of patients who died in hospital
Measured: Up to Day 28
Changes in PaO2/ FiO2 ratio
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start22 May 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion4 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804943
- Sponsor's protocol ID
- NOA001ARDS01
- Status last verified
- Jul 2024
- First submitted
- 15 Mar 2021
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Study to Investigate the Efficacy and Safety of NOA-001 for the Treatment of Patients With Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT04804943
- Acronym / sponsor ID
- NOA001ARDS01
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- COVID-19, Diffuse Alveolar Damage, DAD, Acute Respiratory Distress Syndrome, ARDS, NOA-001, Hemoperfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- 22 May 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 4 Sep 2025 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NOA-001 group (ARDS caused by Non-COVID-19 cohort) | Experimental | Device: NOA-001Patients will receive the standard and NOA-001 therapy. |
| 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 | Device: NOA-001Patients will receive the standard and NOA-001 therapy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- At Informed Consent
- Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (a)-(d):
- 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)
Key exclusion criteria (41 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOA-001NOA-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. | Device | NOA-001 group (ARDS caused by COVID-19 cohort), NOA-001 group (ARDS caused by Non-COVID-19 cohort) |
Primary outcome
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.
4 secondary outcomes
All-cause Mortality
Time frame: Up to Day 28, 60 and 90
Mortality in ICU
Time frame: Up to Day 28
Mortality in Hospital
Time frame: Up to Day 28
Changes in PaO2/ FiO2 ratio
Time frame: Up to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOA-001 in people with Acute Respiratory Distress Syndrome, run by Toray Industries, Inc at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NOA-001 Team (+81 3 3245 8588, clinical-trials.toray.mb@mail.toray), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator Free Days (VFD, Days alive and ventilator-free) (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.