Efficacy and Safety Evaluation of BZ371B in ARDS Patients

Early Phase 1

Terminated

• Conditions: ARDS; ARDS, Human; Pulmonary Disease
• Interventions: Drug: Inhaled BZ371B

• Registration Number: NCT05384379
• Lead Sponsor: Biozeus Biopharmaceutical S.A.

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 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.

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Study Start: 2022-11-23
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated Group	Inhaled BZ371B	Intubated patients treated with inhaled BZ371B will receive a dose of 12 mg of BZ371B divided in two different nebulizations per day, for three cosnecutive days

Primary Outcome Measures

Name	Time	Method
P/F ratio	4 days	PaO2 divided by FiO2 measurement
Shunt ratio	4 days	Shunt ratio measurement
Ventilation-Perfusion (V/Q) ratio	4 days	V/Q measurement
Systemic blood pressure (SBP)	4 days	SBP measurement
Cardiac Function	4 days	Heart Rate (HR) and Ejection Fraction measurement
Adverse Effect	4 days	Adverse effect evaluation of compound use and application

Secondary Outcome Measures

Name	Time	Method
Pulmonary arterial pressure (PAP)	4 days	PAP measurement
Pulmonary vascular resistence	4 days	Pulmonary vascular resistance measurement

Trial Locations

Locations (1)

InCor USP; 🇧🇷 São Paulo, Brazil