Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000588998
Ethics application status
Approved
Date submitted
5/05/2020
Date registered
21/05/2020
Date last updated
30/07/2020
Date data sharing statement initially provided
21/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The safety and efficacy of STC3141 in patient with COVID-19 Acute Respiratory Distress Syndrome
Scientific title
The safety and efficacy of STC3141 in patient with COVID-19 ARDS require intensive care
Secondary ID [1] 301137 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 infection 317248 0
Condition category
Condition code
Infection 315382 315382 0 0
Other infectious diseases
Respiratory 315463 315463 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two- stage study.
Stage 1: Patients will receive STC3141 60 mg/hr as an initial infusion rate which was based on phase Ia study in health volunteer and 60mg/hr is the dosage in long term infusion in phase Ia without aPTT increase, followed by a dose increase of 10 mg/hr every 6 hours until the max infusion rate is 100 mg/hr or the aPTT reaches 1.5 x ULN which ever comes first, then the infusion rate will be fixed in the rest of time. The infusion will continue at this rate for 72 hr.
Stage 2: Arm 1 will receive STC3141 with the initial infusion rate decided from Stage 1 by DSMB, the dosage will be adjusted every 6 hours according to subjects’ aPTT as same as stage 1. The target aPTT and Maximum dosage will be based on DSMB recommendation based on data from stage 1. The infusion last up to 120 hours, unless the patients is well enough to be discharged from ICU, or pass away or experienced intolerable adverse event etc.
Intervention code [1] 317445 0
Treatment: Drugs
Comparator / control treatment
Standard of care is considered as any treatment as determined by treating clinician
Control group
Active

Outcomes
Primary outcome [1] 323633 0
Changes in PaO2/FiO2 assessed by arterial blood gases and ventilator measures
Timepoint [1] 323633 0
end of infusion in stage 2
Primary outcome [2] 323834 0
Incidence, nature and severity of AEs and SAEs
Timepoint [2] 323834 0
D10 in stage 1
Primary outcome [3] 323835 0
Incidence of treatment discontinuation due to AEs
Timepoint [3] 323835 0
D10 in stage 1
Secondary outcome [1] 382431 0
ventilator free day to 28 days via medical record
Timepoint [1] 382431 0
day 28 in stage 2
Secondary outcome [2] 382445 0
changes of Sequential organ failure assessment score assessed via SOFA score by investigator
Timepoint [2] 382445 0
end of infusion in stage 2
Secondary outcome [3] 382533 0
changes in Murray Lung Injury Score assessed via Murray LIS by investigator
Timepoint [3] 382533 0
day 5 in stage 2
Secondary outcome [4] 382534 0
changes of lactate assessed via arterial blood gases
Timepoint [4] 382534 0
EOI, last day in ICU in stage 2
Secondary outcome [5] 382535 0
time alive D 28 assessed via medical record
Timepoint [5] 382535 0
Day 28 in stage 2
Secondary outcome [6] 382536 0
time alive and free of ICU assessed via medical record
Timepoint [6] 382536 0
day 28 in stage 2
Secondary outcome [7] 382537 0
time alive and free of hospital assessed via medical record ( it is a composite outcome)
Timepoint [7] 382537 0
day 28 in stage 2

Eligibility
Key inclusion criteria
Subjects entering the ICU and presenting with confirmed or suspected COVID-19-related ARDS will be enrolled in the trial.
1. Aged 18 to 80 years (inclusive at the time of consent)
2. Subjects are diagnosed with moderate to severe ARDS that has been present for less than 3 days
3. Meet Berlin Definition
1) Must have a partial pressure of arterial O2 (PaO2)/ fraction of inspired O2 (FiO2) less than or equal to 200 mmHg on invasive or non-invasive ventilation with the level of positive end-expiratory pressure (PEEP) or continuous positive pressure (CPAP) greater than or equal to 5cmH2O.
2) Bilateral opacities not fully explained by effusion, lobar or lung collapse, or nodules by chest X-ray or CT
3) Respiratory failure not fully explained by heart failure or fluid overload
In the opinion of the treating clinicians, likely to survive beyond the day after tomorrow.
4. Subjects who are consented
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who have <55 ml/min/BSA
2. Subjects who require ECMO
3. Subjects who require a therapeutic dose of heparin or who are receiving oral
anticoagulants, or received warfarin, factor Xa inhibitors within last 24 hours
4. Subjects who have Absolute Neutrophil Count (ANC) <1000/mL;
6. Subjects who have activated Partial Thromboplastin Time (aPTT) >55 s;
7. Severe anaemia (haemoglobin;
8. Bleeding in the past 24 hours requiring blood transfusion;
9. Subjects who have the following chronic organ dysfunction or immunosuppression

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
Who is / are masked / blinded?



Intervention assignment
Other design features
The stage 1 is an open-label, single arm study. The stage 2 is a open-label, randomized, standard of care- controlled study.
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
29/05/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 305578 0
Commercial sector/Industry
Name [1] 305578 0
Grand Medical Pty Ltd
Country [1] 305578 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Grand Medical Pty Ltd
Address
Shop 6/207 Pacific Highway
St Leonards, NSW 2065 Australia
Country
Australia
Secondary sponsor category [1] 306027 0
None
Name [1] 306027 0
Address [1] 306027 0
Country [1] 306027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305880 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305880 0
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7103 Liverpool BC NSW 1871
Ethics committee country [1] 305880 0
Australia
Date submitted for ethics approval [1] 305880 0
01/04/2020
Approval date [1] 305880 0
21/04/2020
Ethics approval number [1] 305880 0

Summary
Brief summary
The pathophysiology of ARDS and sepsis involves a dysregulated response of the immune system to infection. NET-associated proteins, particularly histones play very important role and cause significant tissue damage, which correlate highly with death as an outcome.
Our hypothesis is to use STC3141 to neutralize the extracellular histone/NETs.
Continuous infusion STC3141 up to 5 days while the patients are on ventilators in ICU compare to standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101914 0
Prof Anders Aneman
Address 101914 0
Liverpool Hospital
75 Elizabeth Street
Liverpool NSW 2170
Country 101914 0
Australia
Phone 101914 0
+61 02 8738 3400
Fax 101914 0
Email 101914 0
[email protected]
Contact person for public queries
Name 101915 0
Dr Marcel Tanudji
Address 101915 0
207 Pacific Highway/Shop 6
St Leonards, NSW 2065
Australia
Country 101915 0
Australia
Phone 101915 0
+61 02 9964 8451
Fax 101915 0
Email 101915 0
[email protected]
Contact person for scientific queries
Name 101916 0
Dr Marcel Tanudji
Address 101916 0
207 Pacific Highway/Shop 6
St Leonards, NSW 2065
Australia
Country 101916 0
Australia
Phone 101916 0
+61 02 9964 8451
Fax 101916 0
Email 101916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.