ARDS, ARDS, Human, Pulmonary Disease
Conditions
Keywords
ARDS, Acute respiratory distress syndrome, Intubation, intubated, critical care, Nitric Oxide, NO, NOS, Nitric Oxide Synthase, BZ371B
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.
Interventions
DRUGInhaled 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.
Sponsors
InCor Heart Institute
Biozeus Biopharmaceutical S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effect | 4 days | Adverse effect evaluation of compound use and application |
| Systemic blood pressure (SBP) | 4 days | SBP measurement |
| Cardiac Function | 4 days | Heart Rate (HR) and Ejection Fraction measurement |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary vascular resistence | 4 days | Pulmonary vascular resistance measurement |
| Pulmonary arterial pressure (PAP) | 4 days | PAP measurement |
Countries
Brazil
Outcome results
None listed