ARDSEarly Phase 1NCT05384379
Efficacy and Safety Evaluation of BZ371B in ARDS Patients
A Early Phase 1 study testing Inhaled BZ371B in people with ARDS and ARDS, Human, run by Biozeus Biopharmaceutical S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, ARDS, Human, Pulmonary Disease
- What is being tested?
- Inhaled BZ371B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Nov 2022to 3 Mar 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of pulmonary thromboembolism
- Presence of secondary bacterial pneumonia
- Severe Asthma
- Pregnant or lactanting women
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome.
Read the 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
- ARDS, ARDS, Human, Pulmonary Disease
- Being tested
- Inhaled BZ371B
- Keywords
- ARDS, Acute respiratory distress syndrome, Intubation, intubated, critical care, Nitric Oxide, NO, NOS, Nitric Oxide Synthase, BZ371B
- Medical subject headings
- Respiratory Distress Syndrome, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled BZ371BDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Inhaled BZ371B |
What is being measured
The primary outcome is the main question the study is designed to answer.
P/F ratio
PaO2 divided by FiO2 measurement
Measured: 4 days
Shunt ratio
Shunt ratio measurement
Measured: 4 days
Ventilation-Perfusion (V/Q) ratio
V/Q measurement
Measured: 4 days
Systemic blood pressure (SBP)
SBP measurement
Measured: 4 days
Cardiac Function
Heart Rate (HR) and Ejection Fraction measurement
Measured: 4 days
Adverse Effect
Adverse effect evaluation of compound use and application
Measured: 4 days
Secondary outcomes (2)
Pulmonary arterial pressure (PAP)
PAP measurement
Measured: 4 days
Pulmonary vascular resistence
Pulmonary vascular resistance measurement
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start23 Nov 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Why it stopped: Suboptimal enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biozeus Biopharmaceutical S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InCor Heart Institute
- Responsible party
- Sponsor
- Investigators
- Marcelo BP Amato, Phd, Principal investigator, Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384379
- Sponsor's protocol ID
- BZ371CLI301
- Status last verified
- May 2023
- First submitted
- 17 May 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05384379
- Acronym / sponsor ID
- BZ371CLI301
- Conditions
- ARDS, ARDS, Human, Pulmonary Disease
- Keywords
- ARDS, Acute respiratory distress syndrome, Intubation, intubated, critical care, Nitric Oxide, NO, NOS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suboptimal enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Biozeus Biopharmaceutical S.A.Industry (pharma, biotech, devices)
- Collaborators
- InCor Heart Institute
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Drug: Inhaled BZ371BIntubated 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of pulmonary thromboembolism
- Presence of secondary bacterial pneumonia
- Severe Asthma
- Pregnant or lactanting women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled BZ371BIntubated 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. | Drug | Treated Group |
Primary outcome
P/F ratio
Time frame: 4 days
PaO2 divided by FiO2 measurement
Shunt ratio
Time frame: 4 days
Shunt ratio measurement
Ventilation-Perfusion (V/Q) ratio
Time frame: 4 days
V/Q measurement
Systemic blood pressure (SBP)
Time frame: 4 days
SBP measurement
Cardiac Function
Time frame: 4 days
Heart Rate (HR) and Ejection Fraction measurement
Adverse Effect
Time frame: 4 days
Adverse effect evaluation of compound use and application
2 secondary outcomes
Pulmonary arterial pressure (PAP)
Time frame: 4 days
Pulmonary vascular resistence
Time frame: 4 days
Results and safety
The study was stopped early (reason given: Suboptimal enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo BP Amato, Phd principal investigator
Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Inhaled BZ371B in people with ARDS and ARDS, Human, run by Biozeus Biopharmaceutical S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Suboptimal enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P/F ratio (time frame: 4 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.