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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04848272




Registration number
NCT04848272
Ethics application status
Date submitted
13/04/2021
Date registered
19/04/2021

Titles & IDs
Public title
Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
Scientific title
Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
Secondary ID [1] 0 0
SVI-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Injury 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lanadelumab
Other interventions - Saline control

Placebo comparator: Saline control - Saline control

Experimental: Lanadelumab 30 mg - Lanadelumab 30 mg

Experimental: Lanadelumab 100 mg - Lanadelumab 100 mg

Experimental: Lanadelumab 300 mg - Lanadelumab 300 mg


Treatment: Drugs: Lanadelumab
Monoclonal antibody that targets active plasma kallikrein

Other interventions: Saline control
Saline control
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Related Adverse Events
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Blood bradykinin concentration
Timepoint [1] 0 0
0, 6, 12, and 24 hours

Eligibility
Key inclusion criteria
* Age >18 years admitted to the ICU with primary diagnosis of lung injury. The criteria for the diagnosis of lung injury include five principal elements: hypoxemia (blood oxygen saturation (PaO2) =92% when breathing ambient air, ratio of PaO2 to the fraction of inspired oxygen (FiO2) =300), diffuse pulmonary infiltrates on chest radiographs, decreased lung compliance, and the absence of congestive heart failure.
* Both males and females will be recruited in the proportion in which they are admitted to the ICU with lung injury.
* Arterial cannula in place as part of usual care for the measurement of blood gases.
* Patients may or may not be intubated and mechanically ventilated.
* Able to provide informed consent, or if unable to do so, a responsible person:

medical treatment decision maker is available (by telephone if necessary) who can be approached to seek consent.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Other causes of lung infiltrates: pulmonary oedema, alveolar haemorrhage, adverse drug reactions, radiation injury and the idiopathic pneumonitis syndrome.
* Significant dysfunction of non-pulmonary organs in the opinion of the treating ICU consultant.
* Death is deemed imminent or inevitable or there is underlying disease with a life expectancy of less than 90 days.
* Previously enrolled in this study.
* Enrolled in another study.
* Usually receives home oxygen.
* Usually receives any type of assisted ventilation at home. e.g. continuous positive airway pressure for obstructive sleep apnoea.
* Pregnant or might be pregnant. Women aged 18 to 49 are excluded unless there is documented menopause, hysterectomy or surgical sterilisation, or a pregnancy test is negative.
* Objection from the treating clinician.
* Consent refused by the patient or substitute decision maker.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Institute of Medical Research
Address
Country

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
Anonymised individual participant data (IPD) available to other researchers

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
After completion of study
Available to whom?
To be determined
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/NCT04848272