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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000566932
Ethics application status
Approved
Date submitted
10/05/2020
Date registered
14/05/2020
Date last updated
1/06/2024
Date data sharing statement initially provided
14/05/2020
Date results information initially provided
1/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Randomised clinical trial of interventions for the treatment of COVID-19 in the community setting.
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Scientific title
BEAT COVID-19: A Bayesian adaptive platform, randomised controlled Trial to evaluate the efficacy and safety of interventions for COVID-19.
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Secondary ID [1]
301247
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
BEAT COVID-19
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
317414
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Condition category
Condition code
Infection
315518
315518
0
0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Bayesian adaptive randomisation and analysis methodology will accelerate the acquisition of evidence about the effectiveness and safety of proposed new treatments ensure rapid implementation of new treatments.
Study treatments or interventions will be added to the trial as a protocol treatment appendix after identification by study investigators and then recommendation by the BEAT COVID-19 Candidate Intervention Expert Committee based on safety, biological plausibility and/or efficacy data. Treatments currently include Ciclesonide.
The Ciclesonide domain includes inhaled ciclesonide 320mcg daily for 14 days compared to placebo. Adherence to the intervention will be monitored via a daily participant diary for 28 days post randomisation and follow up calls from the study team.
The treatment or intervention will commence once all necessary approvals are obtained.
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Intervention code [1]
317546
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Treatment: Drugs
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Comparator / control treatment
Study treatments or interventions will be added to the trial as a protocol treatment appendix after identification, assessment and recommendation by the BEAT COVID-19 Candidate Intervention Expert Committee. This includes the assessment of a comparator / control treatment. The treatment or intervention will commence once all necessary approvals are obtained.
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Control group
Active
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Outcomes
Primary outcome [1]
323760
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The primary outcome is the time to first recovery within 28 days of randomisation, defined as the number of days until the participant first reports an absence of all symptoms within 28 days after the date of randomisation.
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Assessment method [1]
323760
0
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Timepoint [1]
323760
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28 days
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Secondary outcome [1]
382797
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Incidence of acute severe cardiorespiratory illness. Defined as SpO2 < 94% on room air, resting HR > 110 or systolic BP < 90 mmHg. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
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Assessment method [1]
382797
0
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Timepoint [1]
382797
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28 days
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Secondary outcome [2]
382798
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Incidence of other COVID-19 related syndromes. Defined as evidence of myocarditis or myocardial ischaemia, neurological disease (including stroke), acute renal insufficiency and thromboembolism. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
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Assessment method [2]
382798
0
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Timepoint [2]
382798
0
28 days
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Secondary outcome [3]
382799
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Incidence of pneumonitis. Defined as airspace opacity on CXR or CT scan. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
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Assessment method [3]
382799
0
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Timepoint [3]
382799
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28 days
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Secondary outcome [4]
382800
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Incidence of tachycardia. Defined as 100 beats per minute as measured by pulse oximetry. Derived from assessment of hospital medical records following notification of admission by participant or local General Practitioner. Participant diaries will record any events on a daily basis in the first 28 days from study enrolment using a provided oximeter. Community based events will be confirmed with participants local General Practitioner in local medical records.
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Assessment method [4]
382800
0
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Timepoint [4]
382800
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28 days
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Secondary outcome [5]
382801
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Incidence of acute respiratory distress syndrome (ARDS). Defined as pneumonitis + PaO2/FiO2 ratio < 300. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
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Assessment method [5]
382801
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Timepoint [5]
382801
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28 days
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Secondary outcome [6]
382802
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Incidence of Intensive Care Unit admission, Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
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Assessment method [6]
382802
0
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Timepoint [6]
382802
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28 days
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Secondary outcome [7]
382803
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Incidence of mechanical ventilation. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
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Assessment method [7]
382803
0
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Timepoint [7]
382803
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28 days
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Secondary outcome [8]
382804
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Incidence of supplementary oxygen administration. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner. Participant diaries will record any use on a daily basis in the first 28 days from study enrolment. Community based events will be confirmed with participants local General Practitioner in local medical records.
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Assessment method [8]
382804
0
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Timepoint [8]
382804
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28 days
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Secondary outcome [9]
382806
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Incidence of hypoxaemia. Defined as SpO2 < 94% on room air as measured by pulse oximetry. Derived from assessment of hospital medical records following notification of admission by participant or local General Practitioner. Participant diaries will record any events on a daily basis in the first 28 days from study enrolment. Community based events will be confirmed with participants local General Practitioner in local medical records.
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Assessment method [9]
382806
0
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Timepoint [9]
382806
0
28 days
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Secondary outcome [10]
382808
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Duration of hospital admission. Defined as at least 1 night admission to hospital. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
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Assessment method [10]
382808
0
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Timepoint [10]
382808
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28 days
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Secondary outcome [11]
382810
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Frequency and severity of adverse events. Adverse events are any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. Assessment of hospital medical records following notification of admission by participant or local General Practitioner. Participant diaries will record on a daily basis the course of COVID-19 infection. Community based events will be confirmed with participants local General Practitioner in local medical records.
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Assessment method [11]
382810
0
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Timepoint [11]
382810
0
Duration of fever. Defined as temperature above 38 degrees Celsius measured by locally available thermometer. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner. Participant diaries will record any events in the first 28 days from study enrolment. Community based events will be confirmed with participants local General Practitioner in local medical records.
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Secondary outcome [12]
382812
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Frequency and severity of adverse events. For the purposes of this study Adverse Events (AEs), defined as any untoward medical occurrence, are those related to study treatment, symptoms of COVID-19 or treatments for management of COVID-19 symptoms. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner. Participant diaries will record any events in the first 28 days from study enrolment. Community based events will be confirmed with participants local General Practitioner in local medical records.
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Assessment method [12]
382812
0
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Timepoint [12]
382812
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28 days
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Secondary outcome [13]
382813
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Occurrence of participant hospitalisation during symptomatic COVID-19 during the first 28 days after randomisation.
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Assessment method [13]
382813
0
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Timepoint [13]
382813
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28 days.
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Secondary outcome [14]
382894
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Assessment of participant-reported symptoms and quality of life. Completion of the CCQ on Days 1-14 and Day 28 and EQ-5D–5L questionnaires on Days 1 and 28. Questionnaires will be self-completed online in English. Participants who are not able to self-complete in English will be excluded from this aspect of the study only.
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Assessment method [14]
382894
0
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Timepoint [14]
382894
0
28 days.
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Secondary outcome [15]
382927
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Time to return to normal function. Normal function defined as resolution of symptoms of COVID-19 infection and return to baseline health status prior to infection. Participant diaries will record symptoms in the first 28 days from study enrolment.
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Assessment method [15]
382927
0
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Timepoint [15]
382927
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28 days after randomisation.
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Secondary outcome [16]
382928
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Assessment of participant-reported health and functioning, quality of life at 3 and 6 months. Completion of PROMIS Global Health 10 (PGH) and EQ-5D–5L questionnaires at follow up visit with attending clinician. This instrument has 10 items and 4 summary scores. Physical Health (items 3 6 7 8 ), Mental Health (items 2 4 5 10) General Health (item 1) Roles/activities (item 9).
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Assessment method [16]
382928
0
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Timepoint [16]
382928
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3 and 6 months after randomisation
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Secondary outcome [17]
384706
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Assessment Survival at 3 and 6 months. Participant assessment by attending clinician 3 and 6 months after randomisation. Assessment of hospital medical records or contact with local General Practitioner if participant does not attend consultation
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Assessment method [17]
384706
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Timepoint [17]
384706
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3 and 6 months after randomisation.
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Eligibility
Key inclusion criteria
1. Adult, aged greater than or equal to 18 years.
2. PCR or RAT-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
3. Intention for community-based management.
4. Eligibility to at least one recruiting domain.
5. Participant & treating clinician are willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments, and.
6. Documented informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Currently pregnant or breast-feeding
2. Any medical condition which, in the opinion of the Investigator, may affect the participant’s safety or study participation and conduct
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Bayesian adaptive randomisation platform controlled trial
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The assessment of hospitalisation or death rates from COVID-19 and assessment of rates for events for secondary endpoints to measure the study intervention's influence on a COVID-19 related events.
Bayesian adaptive randomisation and analysis methodology is planned which allows effectiveness and safety to be regularly compared at any point in the trial.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
25/10/2021
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Actual
16/03/2022
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Date of last participant enrolment
Anticipated
31/10/2023
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Actual
26/09/2023
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Date of last data collection
Anticipated
29/12/2023
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Actual
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Sample size
Target
250
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Accrual to date
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Final
195
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
24459
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John Hunter Hospital - New Lambton
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Recruitment postcode(s) [1]
35528
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2050 - Camperdown
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Recruitment postcode(s) [2]
40041
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2305 - New Lambton
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Funding & Sponsors
Funding source category [1]
309902
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Government body
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Name [1]
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NSW Ministry of Health
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Address [1]
309902
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1 Reserve Road
St Leonards, NSW 2065
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Country [1]
309902
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
Western Avenue,
Camperdown
Sydney
New South Wales 2006
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Country
Australia
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Secondary sponsor category [1]
306110
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None
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Name [1]
306110
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Address [1]
306110
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Country [1]
306110
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305972
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Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
305972
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Level 11, KGV Building Missenden Road. CAMPERDOWN NSW 2050
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Ethics committee country [1]
305972
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Australia
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Date submitted for ethics approval [1]
305972
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20/05/2020
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Approval date [1]
305972
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24/07/2020
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Ethics approval number [1]
305972
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Summary
Brief summary
The aim of this study is to accelerate the implementation of treatments to reduce the burden of morbidity and mortality due to severe respiratory disease in people with COVID-19.
Who is it for?
You may be eligible to join this study if you have a confirmed diagnosis of COVID-19, are aged 18 years or more, and do not have clinical features of severe respiratory disease or require inpatient care.
Study details
Participants in this study will be randomly allocated (by chance) to a treatment group. Treatments will be added during the course of the trial and will only commence once necessary approvals have been obtained.
All participants will be monitored for various events, such as hospital admission, ICU admission, mechanical ventilation, fever, symptoms and adverse events. It is hoped that this study will accelerate the acquisition of evidence about the effectiveness and safety of proposed new treatments, ensure patients with COVID-19 receive the optimal treatment for their condition based on the best current evidence at the time they are being treated, and ensure rapid implementation of new treatments
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Guy Marks
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Address
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University of New South Wales
Sydney NSW 2052
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Country
102262
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Australia
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Phone
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+61 02 8738 3000
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Fax
102262
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Email
102262
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[email protected]
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Contact person for public queries
Name
102263
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Ms Karen Allison
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Address
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NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450 Australia
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Country
102263
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Australia
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Phone
102263
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+61 02 9562 5000
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Fax
102263
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Email
102263
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[email protected]
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Contact person for scientific queries
Name
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Prof Guy Marks
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Address
102264
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University of New South Wales
Sydney NSW 2052
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Country
102264
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Australia
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Phone
102264
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+61 02 8738 3000
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Fax
102264
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Email
102264
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
to be confirmed
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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.
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