NCT05384379

TerminatedEarly Phase 1

Efficacy and Safety Evaluation of BZ371B in ARDS Patients

Biozeus Biopharmaceutical S.A.Source

Biozeus Biopharmaceutical S.A.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BZ371CLI301

Study Type

interventional

Actual enrollment (reported)

1

Locations

1 country

Sites

1

Timeline

Study Start

November 23, 2022

Actual (reported)

Primary Completion

March 3, 2023

Actual (reported)

Study Completion

March 3, 2023

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 1 participants
Study completion date: March 3, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 17, 2022
Actual (reported)
First Posted
May 20, 2022
Actual (reported)
Study Start
November 23, 2022
Actual (reported)
Primary Completion
March 3, 2023
Actual (reported)
Study Completion
March 3, 2023
Actual (reported)

Last Updated: June 1, 2023
Status Verified: May 2023
Last Update Submitted: May 30, 2023

Conditions

ARDS ARDS, Human Pulmonary Disease

Keywords

ARDSAcute respiratory distress syndromeIntubationintubatedcritical careNitric OxideNONOSNitric Oxide SynthaseBZ371B

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

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 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.

Treated Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years old or older
Men or Women

Sponsors & Collaborators

Biozeus Biopharmaceutical S.A.
Industrylead
InCor Heart Institute
Othercollaborator

Study Sites (1)

InCor USP

São Paulo, 05403-900, Brazil

MeSH Terms

Conditions

Respiratory Distress SyndromeLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration Disorders

Study Officials

Marcelo BP Amato, Phd
Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo
PRINCIPAL INVESTIGATOR

Enrollment

1 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT03346681

N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome

Early Phase 1Withdrawn

NCT00295269

Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome

Phase 3Completed

NCT04909879

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

Phase 2Withdrawn

NCT00281268

Fluids and Catheters Treatment Trial (FACTT) - ARDS Clinical Research Network

Phase 3Completed

NCT06564207

Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults

Phase 2Not Yet Recruiting

NCT04998253

Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2

Early Phase 1Completed

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

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

Contact the study team to confirm eligibility.

Primary Completion

March 3, 2023

Actual (reported)

Study Completion

March 3, 2023

Actual (reported)

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05384379
Data provider: ClinicalTrials.gov
Source updated: 2023-06-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:12 UTC

Locations

BR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (1)

Treated Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

You may not qualify if:

Data Sharing

Source record

Locations