Efficacy and Safety Evaluation of BZ371B in ARDS Patients

ARDS Clinical Trial

Official title:

Clinical Study to Evaluate the Efficacy and Safety od BZ371B in Patients With Acute Respiratory Distress System (ARDS) in Mechanical Ventilation, Due to Respiratory Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05384379
• Other study ID #: BZ371CLI301
• Status: Terminated
• Phase: Early Phase 1
• Start date: November 23, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: May 2023
• Source: Biozeus Biopharmaceutical S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 infections such as SARS-CoV-2 can be responsible for the development of the disease. ARDS presents a high mortality rate, which may range from 33-52%. The main difficulty for the treatment of this disease is dealing with hypoxia. Nitric Oxide inhalation therapy has proven to increase oxygenation and Ventilation/Perfusion by it's vasodilation property. However, there are several limitations for it's use, such as the need of a specialized equipment, systemic side effects, etc. The use of others vasodilation medications are not indicated due to their systemic systemic exposure and non-selective vasodilation. BZ371B is a small peptide that acts as a NO synthase (NOS) enhancer, inducing local NO production, and is capable to present local vasodilation effect increasing blood flow regulation, by a new and innovative mechanism of action.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• ARDS, Human
• Pulmonary Disease
• Respiratory Distress Syndrome

Intervention

Drug:
• Inhaled BZ371B
Intubated patients suffering from ARDS will receive BZ371B in a dose of 12 mg. This will be divided into 2 nebulizations, each with 10 ml. The first nebulization is at a dose of 3 mg and the second at a dose of 9 mg.

Locations

Country	Name	City	State
Brazil	InCor USP	São Paulo

Sponsors (2)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P/F ratio	PaO2 divided by FiO2 measurement	4 days
Primary	Shunt ratio	Shunt ratio measurement	4 days
Primary	Ventilation-Perfusion (V/Q) ratio	V/Q measurement	4 days
Primary	Systemic blood pressure (SBP)	SBP measurement	4 days
Primary	Cardiac Function	Heart Rate (HR) and Ejection Fraction measurement	4 days
Primary	Adverse Effect	Adverse effect evaluation of compound use and application	4 days
Secondary	Pulmonary arterial pressure (PAP)	PAP measurement	4 days
Secondary	Pulmonary vascular resistence	Pulmonary vascular resistance measurement	4 days