Status:
TERMINATED
Efficacy and Safety Evaluation of BZ371B in ARDS Patients
Lead Sponsor:
Biozeus Biopharmaceutical S.A.
Collaborating Sponsors:
InCor Heart Institute
Conditions:
ARDS
ARDS, Human
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome.
Detailed Description
Acute respiratory distress syndrome (ARDS) is a severe medical condition that is triggered by an alveolar capillary membrane damage resulted from several causes. Among these causes, respiratory viral ...
Eligibility Criteria
Inclusion
- 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
- Presence of pulmonary thromboembolism
- Presence of secondary bacterial pneumonia
- Severe Asthma
- Pregnant or lactanting women
Key Trial Info
Start Date :
November 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05384379
Start Date
November 23 2022
End Date
March 3 2023
Last Update
June 1 2023
Active Locations (1)
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1
InCor USP
São Paulo, Brazil, 05403-900