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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorToray Industries, Inc

About this trial

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).

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • NOA-001

Treatment groups

45 Participants
are divided into 3 treatment groups

Sponsors and collaborators