Efficacy and Safety Evaluation of BZ371B in ARDS Patients

Sponsor

Biozeus Biopharmaceutical S.A. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05384379

Collaborator

InCor Heart Institute (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS ARDS, Human Pulmonary Disease	Drug: Inhaled BZ371B	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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.

Arm

Intervention/Treatment

Experimental: 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

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.

Outcome Measures

Primary Outcome Measures

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

Pulmonary arterial pressure (PAP) [4 days]
PAP measurement
Pulmonary vascular resistence [4 days]
Pulmonary vascular resistance measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.