Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001200875
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
8/09/2021
Date last updated
10/12/2021
Date data sharing statement initially provided
8/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of Dexamethasone for Emergency and Life-Threatening Admissions due to COVID-19 in Virtual Care: the DELTA study
Scientific title
A randomised controlled trial of Dexamethasone for Emergency and Life-Threatening Admissions due to COVID-19 in Virtual Care: the DELTA study
Secondary ID [1] 305073 0
None
Universal Trial Number (UTN)
Trial acronym
DELTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 Delta Variant
 323292 0
Condition category
Condition code
Infection 320858 320858 0 0
Other infectious diseases
Respiratory 320943 320943 0 0
Other respiratory disorders / diseases
Emergency medicine 320944 320944 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Usual care as per local hospital protocols for COVID-19 plus oral dexamethasone. Those receiving oral dexamethasone will be required to take 6mg orally per day for 2 days. We will contact the patient daily to assess for study drug adherence.
Intervention code [1] 321470 0
Treatment: Drugs
Comparator / control treatment
Usual care as per local hospital protocols for COVID-19 plus inactive comparator as placebo (150mg of thiamine per day for 2 days).
Control group
Placebo

Outcomes
Primary outcome [1] 328670 0
COVID-19 related hospitalization, defined as COVID-19 related emergency presentation (excluding injuries and presentations for social reasons), or hospital admission or intensive care unit admission or death. Decisions about COVID-19 relatedness will be made after independent review of available data by two clinicians masked to treatment allocation.

This data will be collected using data linkage to electronic medical records
Timepoint [1] 328670 0
For a data collection period until Jan 2022, with data updated weekly until end of the data collection period
Secondary outcome [1] 399884 0
Self-reported symptom severity

Symptom severity and symptom resolution will be based on the Common Cold Questionnaire
Timepoint [1] 399884 0
At baseline, at 14 days after enrolment, and at 28 days after enrolment
Secondary outcome [2] 399885 0
Self-reported well-being measured using the WHO-5 Well Being Index as reported in the PRINCIPLE study
Timepoint [2] 399885 0
At baseline, at 14 days after enrolment, and at 28 days after enrolment
Secondary outcome [3] 399888 0
PCR estimates of SARS-CoV2 viral load based on progress swabs in the subset of hospitalized patients.
Timepoint [3] 399888 0
Opportunistically as available during the primary hospital admission (progress swabs) until initial participant discharge
Secondary outcome [4] 400125 0
Intensive care admission

This data will be collected using data linkage to electronic medical records
Timepoint [4] 400125 0
For a data collection period until Jan 2022, with data updated weekly until end of the data collection period
Secondary outcome [5] 400126 0
Ventilation days

This data will be collected using data linkage to electronic medical records
Timepoint [5] 400126 0
For a data collection period until Jan 2022, with data updated weekly until end of the data collection period
Secondary outcome [6] 400127 0
Total hospital length of stay

This data will be collected using data linkage to electronic medical records
Timepoint [6] 400127 0
For a data collection period until Jan 2022, with data updated weekly until end of the data collection period
Secondary outcome [7] 400625 0
Participant self-reported time to symptom resolution assessed up to 14 days from enrolment using a daily symptom diary (modified Common Cold Questionnaire).
Timepoint [7] 400625 0
Daily up to 14 days post enrolment

Eligibility
Key inclusion criteria
- Adult patients (age greater than or equal to 18 years)
- Currently under the care of RPAV in the community or Special Health Accommodation (SHA)
- Confirmed COVID-19 on Polymerase Chain Reaction (PCR) testing within the last 14 days
- Exhibiting mild/moderate COVID-19 symptoms (fever, respiratory tract symptoms, chest pain, lethargy, dizziness, myalgia, anosmia, dyspnea, headache, gastrointestinal symptoms), with no requirement for oxygen or hospitalization
- Requiring nursing or medical assessment by RPA Virtual Hospital clinicians within 72 hours for new or escalating symptoms of mild to moderate COVID-19
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently taking oral or inhaled corticosteroids
- Major medical or psychiatric comorbidities precluding the use of corticosteroids (e.g. poorly controlled diabetes mellitus, chronic heart disease, chronic renal disease, chronic liver failure, schizophrenia or thought disorder, bipolar disorder)
- Immunosuppression or treatment for malignancy
- Hypersensitivity to corticosteroids, thiamine, wheat, lactose, povidone, maize starch or magnesium stearate
- History of alcohol dependence or at risk alcohol intake
- At risk for thiamine deficiency (e.g. eating disorders, chronic malabsorption)
- Requires urgent transfer to the emergency department at the time of assessment
- Patient declines or is unable to provide consent
- Lactating or pregnant women
- No access to a personal or loaned electronic device,
- Unable to read or write English

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)
Allocation will involve contacting the holder of an allocation schedule, who will be offsite.

Study group allocation will be concealed from RPA Virtual Hospital clinicians responsible for outcome assessments and transfer decisions to Emergency Departments
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed with the use of a Web-based system
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
Participants will be masked to treatment allocation, to the extent that treatment and inactive comparator (placebo) tablets are near-identical as scored white tablets of near identical size, with the only appreciable difference being the marking “DS4” on one side of dexamethasone tablets, compared to no markings on thiamine tablets. Participants will not be told which tablet they are receiving, and the tablets will be handed to the patient in an opaque jar.

Clinicians will be masked to treatment allocation, to the extent that they will not be told which group any given patient has been allocated to and will be instructed not to ask patients about the tablet they received. Participants will also be encouraged not to disclose this information to treating clinicians.

Outcome assessors will be blinded to treatment allocation through the use of a master code sheet with access to group allocation variables provided only to study coordinator and not those contacting patients or accessing medical records
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
A formal statistical analysis plan will be developed in consultation with a biostatistician prior to the commencement of the study. The analysis will be gated to a single primary outcome. Categorical outcomes will be compared using chi square tests and time to symptom resolution compared using Wilcoxon Rank Sum tests, Kaplan Meier curves and Cox Proportional Hazards modelling

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/09/2021
Actual
23/09/2021
Date of last participant enrolment
Anticipated
14/01/2022
Actual
Date of last data collection
Anticipated
14/02/2022
Actual
Sample size
Target
650
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309471 0
Other Collaborative groups
Name [1] 309471 0
Green Light Institute for Emergency Care
Country [1] 309471 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
50 Missenden Road, Camperdown, New South Wales 2050
Country
Australia
Secondary sponsor category [1] 310441 0
None
Name [1] 310441 0
Address [1] 310441 0
Country [1] 310441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309260 0
Sydney Local Health District Ethics Review Committee
Ethics committee address [1] 309260 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
50 Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 309260 0
Australia
Date submitted for ethics approval [1] 309260 0
16/08/2021
Approval date [1] 309260 0
02/09/2021
Ethics approval number [1] 309260 0

Summary
Brief summary
The DELTA study is a double blinded parallel arm randomised controlled trial designed to test the hypothesis that a two-day course of oral dexamethasone in mild to moderate COVID-19 patients results in fewer COVID-19 related hospitalisations, intensive care unit admissions and death; and reduced time to self-reported symptom resolution.

Once patients have consented to participate in the study, they will be randomised to receive either 6mg oral dexamethasone or 150mg thiamine (placebo).

Study information will be collected from electronic Medical Records (eMR). Only routinely collected data will be used for this study, and will include disposition, intensive care admission, ventilation days and total hospital length of stay.

Data managers and/or clinical nurse consultants will assist with data extraction. Data will be collected and entered into SLHD RedCap. Data analysis will follow.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113530 0
A/Prof Michael Dinh
Address 113530 0
Royal Prince Alfred Hospital
Level 10, King George V Building, Camperdown, New South Wales 2050
Country 113530 0
Australia
Phone 113530 0
+61 419620654
Fax 113530 0
Email 113530 0
Michael.Dinh@health.nsw.gov.au
Contact person for public queries
Name 113531 0
A/Prof Michael Dinh
Address 113531 0
Royal Prince Alfred Hospital
Level 10, King George V Building, Camperdown, New South Wales 2050
Country 113531 0
Australia
Phone 113531 0
+61 419620654
Fax 113531 0
Email 113531 0
Michael.Dinh@health.nsw.gov.au
Contact person for scientific queries
Name 113532 0
A/Prof Michael Dinh
Address 113532 0
Royal Prince Alfred Hospital
Level 10, King George V Building, Camperdown, New South Wales 2050
Country 113532 0
Australia
Phone 113532 0
+61 419620654
Fax 113532 0
Email 113532 0
Michael.Dinh@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication and for at least 15 years post publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator. Contact A/Prof Michael Dinh on Michael.Dinh@health.nsw.gov.au


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.