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ARDS
+2

Efficacy and Safety Evaluation of BZ371B in ARDS Patients

Sponsored by Biozeus Biopharmaceutical S.A.

About this trial

Last updated 2 years ago

Study ID

BZ371CLI301

Status

Terminated

Type

Interventional

Phase

Early Phase 1

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

Exclusion Criteria

- Presence of pulmonary thromboembolism

- Presence of secondary bacterial pneumonia

- Severe Asthma

- Pregnant or lactanting women

Locations

Location

Status