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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05947955




Registration number
NCT05947955
Ethics application status
Date submitted
9/07/2023
Date registered
17/07/2023

Titles & IDs
Public title
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Scientific title
A Phase 2 Randomized Double-blind Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Care For Moderate-to-Severe ARDS Due To Pneumonia Or Other Infections
Secondary ID [1] 0 0
BTI-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Distress Syndrome 0 0
Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rhu-pGSN
Treatment: Drugs - normal saline

Experimental: Rhu-pGSN Treatment - Subjects will receive rhu-pGSN 24 mg/kg once, followed by 5 daily doses of 12 mg/kg based on actual body weight in addition to standard care .

Placebo comparator: Normal Saline Placebo - Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care.


Treatment: Drugs: Rhu-pGSN
Intravenous administration based on actual body weight

Treatment: Drugs: normal saline
intravenous administration in the same volume as the active therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality at day 28
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Ventilator-free days
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
All-cause mortality at day 60
Timepoint [2] 0 0
60 days
Secondary outcome [3] 0 0
Proportion of surviving subjects without respiratory support
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Time to death and proportions of subjects dying over time
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Time to discontinuation of respiratory support and proportions without respiratory support
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Frequency of intubation
Timepoint [6] 0 0
28 days
Secondary outcome [7] 0 0
Days in the ICU and in the hospital
Timepoint [7] 0 0
28 days
Secondary outcome [8] 0 0
Frequency of RRT
Timepoint [8] 0 0
28 days
Secondary outcome [9] 0 0
SAEs and AEs
Timepoint [9] 0 0
28 days

Eligibility
Key inclusion criteria
1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist

* Investigator or designee to note radiologic findings in the electronic case report form (eCRF)
* Radiology report and conclusion should be summarized in the eCRF
* A digital copy of the radiograph uploaded and saved for review
2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for =48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 =150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP =5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.
3. Age =18 years
4. Informed consent obtained from subject/next of kin/legal proxy
5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team
6. During the course of the study starting at screening and for at least 3 months after their final study treatment:

1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods
2. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner
3. All subjects must agree not to donate sperm or eggs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.
2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection
3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO)
4. Pregnant or lactating women
5. Previous splenectomy
6. Any vaccination in the previous 30 days
7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days
8. Known allergy to study drug or excipients
9. Weight >125 kg
10. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months
11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease
12. Chronic mechanical ventilation or dialysis
13. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy <6 months unrelated to acute infection in the opinion of the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioAegis Therapeutics Inc.
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Biomedical Advanced Research and Development Authority
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Howard Levy, MD PhD
Address 0 0
Country 0 0
Phone 0 0
848-992-5888
Fax 0 0
Email 0 0
hlevy@hlevyconsulting.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05947955