## Protocol Section
### Identification Module
**NCT ID:** NCT05384379

**Brief Title:** Efficacy and Safety Evaluation of BZ371B in ARDS Patients

**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

#### Organization Study ID Info
**ID:** BZ371CLI301
#### Organization
**Class:** INDUSTRY
**Full Name:** Biozeus Biopharmaceutical S.A.
### Status Module
#### Completion Date
**Date:** 2023-03-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-30

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2023-03-03

**Type:** ACTUAL

#### Start Date
**Date:** 2022-11-23

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2022-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-17
**Study First Submit QC Date:** 2022-05-17
**Why Stopped:** Suboptimal enrollment
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** InCor Heart Institute

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Biozeus Biopharmaceutical S.A.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- ARDS

- ARDS, Human

- Pulmonary Disease

**Keywords:**

- ARDS

- Acute respiratory distress syndrome

- Intubation

- intubated

- critical care

- Nitric Oxide

- NO

- NOS

- Nitric Oxide Synthase

- BZ371B

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: Inhaled BZ371B

**Label:** Treated Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treated Group

**Description:** 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.

**Name:** Inhaled BZ371B

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** PaO2 divided by FiO2 measurement

**Measure:** P/F ratio

**Time Frame:** 4 days

**Description:** Shunt ratio measurement

**Measure:** Shunt ratio

**Time Frame:** 4 days

**Description:** V/Q measurement

**Measure:** Ventilation-Perfusion (V/Q) ratio

**Time Frame:** 4 days

**Description:** SBP measurement

**Measure:** Systemic blood pressure (SBP)

**Time Frame:** 4 days

**Description:** Heart Rate (HR) and Ejection Fraction measurement

**Measure:** Cardiac Function

**Time Frame:** 4 days

**Description:** Adverse effect evaluation of compound use and application

**Measure:** Adverse Effect

**Time Frame:** 4 days

#### Secondary Outcomes

**Description:** PAP measurement

**Measure:** Pulmonary arterial pressure (PAP)

**Time Frame:** 4 days

**Description:** Pulmonary vascular resistance measurement

**Measure:** Pulmonary vascular resistence

**Time Frame:** 4 days

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** São Paulo

**Country:** Brazil

**Facility:** InCor USP

**Zip:** 05403-900

#### Overall Officials

**Official 1:**

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

**Name:** Marcelo BP Amato, Phd

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: ARDS, Human

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M28144

- Name: Acute Lung Injury

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: LOW

- As Found: Unknown

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012128

- Term: Respiratory Distress Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12507

- Name: Nitric Oxide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
