Efficacy and Safety Evaluation of BZ371B in ARDS Patients

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biozeus Biopharmaceutical S.A.
• Collaborator: InCor Heart Institute

Criteria

Inclusion Criteria:

• 18 years old or older

• Men or Women

• In Mechanical Ventilation

• Diagnosed with Acute Respiratory Dystress Syndrome characterized by: acute beginning (less than one week from the beggining of the disease); bilateral opacity in the Torax X-Ray (not explained by stroke, atelectasis or nodules); respiratory failure not derived from cardiac failure and water overload.

• P/F lower or equal to 150 mmHg with FiO2 higher or equal to 70% and PEEP higher or or equal to 88 mmHg

• ALready executed first pronation, followed by supine position. One hour after returning from supine position.

Exclusion Criteria:

• Presence of pulmonary thromboembolism

• Presence of secondary bacterial pneumonia

• Severe Asthma

• Pregnant or lactanting women