Efficacy and Safety Evaluation of BZ371B in ARDS Patients

NCT05384379 | Terminated Early Phase 1

• 1 other identifier: BZ371CLI301
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; ARDS, Human; Pulmonary Disease

Keywords

ARDS; Acute respiratory distress syndrome; Intubation; intubated; critical care; Nitric Oxide; NO; NOS; Nitric Oxide Synthase; BZ371B

Outcome Measures

Primary Outcomes (6)

• P/F ratio

  PaO2 divided by FiO2 measurement

  4 days

• Shunt ratio

  Shunt ratio measurement

  4 days

• Ventilation-Perfusion (V/Q) ratio

  V/Q measurement

  4 days

• Systemic blood pressure (SBP)

  SBP measurement

  4 days

• Cardiac Function

  Heart Rate (HR) and Ejection Fraction measurement

  4 days

• Adverse Effect

  Adverse effect evaluation of compound use and application

  4 days

Secondary Outcomes (2)

• Pulmonary arterial pressure (PAP)

  4 days

• Pulmonary vascular resistence

  4 days

Study Arms (1)

Treated Group

EXPERIMENTAL

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

Drug: Inhaled BZ371B

Interventions

Inhaled BZ371B 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.

Treated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of pulmonary thromboembolism
• Presence of secondary bacterial pneumonia
• Severe Asthma
• Pregnant or lactanting women

Sponsors & Collaborators

• Biozeus Biopharmaceutical S.A.: lead
• InCor Heart Institute: collaborator

Study Sites (1)

InCor USP

São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Marcelo BP Amato, Phd

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: November 23, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)