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Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome) | Clinical Trials | Clareo Health

RECRUITINGNA

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.

NCT04804943•Toray Industries, Inc

View on ClinicalTrials.gov

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).

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).

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•(ARDS caused by Non-COVID-19 cohort)
•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)
+19 more criteria

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)
+31 more criteria

Locations (1)

Showa University Hospital

Tokyo, Japan

Key Dates

Start Date

May 22, 2021

Primary Completion Date

June 30, 2025

Completion Date

September 4, 2025

Last Updated

July 9, 2024

Enrollment

ESTIMATED participants

Conditions

Acute Respiratory Distress Syndrome

Interventions

NOA-001

DEVICE

Contacts

NOA-001 Team

CONTACT

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

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NCT07450846

Acute Respiratory Distress SyndromeRight Heart Failure

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Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

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Acute Respiratory Distress Syndrome (ARDS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Assessment of Airway Opening Pressure in Invasively Ventilated Children

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