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