Efficacy and Safety Evaluation of BZ371B in ARDS Patients

NCT ID: NCT05384379

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2023-03-03

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.

Conditions

ARDS; ARDS, Human; Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treated Group

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

Group Type: EXPERIMENTAL

Inhaled BZ371B

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InCor Heart Institute

OTHER

Sponsor Role: collaborator

Biozeus Biopharmaceutical S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo BP Amato, Phd

Role: PRINCIPAL_INVESTIGATOR

Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo

Locations

InCor USP

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

BZ371CLI301

Identifier Type: -

Identifier Source: org_study_id