Clinical trial NCT05384379: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: ARDS
ARDS, Human
Pulmonary Disease
Keywords: ARDS
Acute respiratory distress syndrome
Intubation
intubated
critical care
Nitric Oxide
NO
NOS
Nitric Oxide Synthase
BZ371B
Lead sponsor: Biozeus Biopharmaceutical S.A.
Sponsor class: INDUSTRY
Collaborators: name: InCor Heart Institute
First posted: 2022-05-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: P/F ratio
timeFrame: 4 days
measure: Shunt ratio
timeFrame: 4 days
measure: Ventilation-Perfusion (V/Q) ratio
timeFrame: 4 days
measure: Systemic blood pressure (SBP)
timeFrame: 4 days
measure: Cardiac Function
timeFrame: 4 days
measure: Adverse Effect
timeFrame: 4 days
Secondary outcomes:
measure: Pulmonary arterial pressure (PAP)
timeFrame: 4 days
measure: Pulmonary vascular resistence
timeFrame: 4 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: InCor USP
Study officials:
affiliation: Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo
name: Marcelo BP Amato, Phd
role: PRINCIPAL_INVESTIGATOR
References: