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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
28/07/2020
Date data sharing statement initially provided
14/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised clinical trial of interventions for the treatment of COVID-19 in the community setting for high risk older people.
Scientific title
BEAT COVID-19: A Bayesian adaptive randomised controlled trial platform to evaluate the efficacy of interventions for high risk older patients with COVID-19 in reducing the risk of hospital admission or death.
Secondary ID [1] 301247 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BEAT COVID-19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317414 0
coronary (ischaemic) heart disease 317417 0
hypertension 317418 0
asthma 317419 0
chronic obstructive pulmonary disease (COPD) 317420 0
diabetes
317421 0
previous stroke 317422 0
active cancer 317423 0
immunosuppression 317424 0
Condition category
Condition code
Infection 315518 315518 0 0
Other infectious diseases
Respiratory 315538 315538 0 0
Other respiratory disorders / diseases
Cardiovascular 315539 315539 0 0
Coronary heart disease
Cardiovascular 315540 315540 0 0
Hypertension
Respiratory 315541 315541 0 0
Asthma
Respiratory 315542 315542 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 315543 315543 0 0
Diabetes
Stroke 315544 315544 0 0
Haemorrhagic
Stroke 315545 315545 0 0
Ischaemic
Cancer 315546 315546 0 0
Any cancer

Intervention/exposure
Study type
Interventional
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. No treatments have been identified for inclusion at this date.

The treatment or intervention will commence once all necessary approvals are obtained.
Intervention code [1] 317546 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 323760 0
Composite primary endpoints of rate of hospital admission or death. 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 death events will be confirmed with participants local General Practitioner in local medical records.
Timepoint [1] 323760 0
28 days
Secondary outcome [1] 382797 0
Incidence of pneumonitis. Defined as bilateral airspace opacity on CXR or CT scan. 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.

Timepoint [1] 382797 0
28 days
Secondary outcome [2] 382798 0
Incidence of acute respiratory distress syndrome (ARDS). Defined as pneumonitis + PaO2/FiO2 ratio < 300. 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.


Timepoint [2] 382798 0
28 days
Secondary outcome [3] 382799 0
Incidence of Intensive Care Unit admission. 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.
Timepoint [3] 382799 0
28 days
Secondary outcome [4] 382800 0
Incidence of mechanical ventilation. 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.
Timepoint [4] 382800 0
28 days
Secondary outcome [5] 382801 0
Incidence of supplementary oxygen administration. Assessment of hospital medical records following notification of admission by participant or local General Practitioner. Participant diaries will record on a daily basis course of COVID-19 infection. Community based events will be confirmed with participants local General Practitioner in local medical records.
Timepoint [5] 382801 0
28 days
Secondary outcome [6] 382802 0
Incidence of hypoxaemia (SpO2 < 94% on room air). Hypoxia will be measured pulse oximetry and recorded in diary and / or local or hospital medical records.
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.
Timepoint [6] 382802 0
28 days
Secondary outcome [7] 382803 0
Duration of hospital admission. 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.
Timepoint [7] 382803 0
28 days
Secondary outcome [8] 382804 0
Duration of fever. Fever is defined as above 38 degrees Celsius and will be assessed by a locally available thermometer. 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.
Timepoint [8] 382804 0
28 days
Secondary outcome [9] 382806 0
Time to return to normal function. Normal function will be defined as resolution of symptoms of COVID-19 infection and return to baseline health status prior to infection. Participant diaries will record on a daily basis the course of COVID-19 infection.
Timepoint [9] 382806 0
28 days
Secondary outcome [10] 382808 0
Composite endpoint of duration of key symptoms – cough, breathlessness, fatigue. Assessment of hospital medical records following notification of admission by participant or local General Practitioner. Participant diaries will record on a daily basis course of COVID-19 infection. Community based events will be confirmed with participants local General Practitioner in local medical records.
Timepoint [10] 382808 0
28 days
Secondary outcome [11] 382810 0
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.
Timepoint [11] 382810 0
28 days
Secondary outcome [12] 382812 0
Quality of life. Quality of life (QoL) using the Eq-5D to be completed by participants 3 and 6 months after randomisation. Completed instruments will be analysed using the QoL scoring manual.
Timepoint [12] 382812 0
3 and 6 months after randomisation
Secondary outcome [13] 382813 0
General health status. Assessment by physical examination, organ function assessed by blood tests (LFT, EUC, FBC), respiratory function (spirometry).
Timepoint [13] 382813 0
3 and 6 months after randomisation
Secondary outcome [14] 382894 0
Blood based biomarkers: microRNA expression and serum proteins. To correlate biomarkers from baseline blood samples with clinical endpoints.
Timepoint [14] 382894 0
Baseline at randomisation, prior to commence of allocated study treatment.
Secondary outcome [15] 382927 0
Incidence of acute severe illness. Defined as SpO2 < 94% on room air, resting HR > 110 or systolic BP < 90 mmHg.
Timepoint [15] 382927 0
28 days
Secondary outcome [16] 382928 0
Survial.
Timepoint [16] 382928 0
3 and 6 months after randomisation
Secondary outcome [17] 384706 0
Incidence of acute severe cardiorespiratory illness. Defined as SpO2 < 94% on room air, resting HR > 110 or systolic BP < 90 mmHg. Assessment of hospital medical records following notification of admission by participant or local General Practitioner.
Timepoint [17] 384706 0
28 days
Secondary outcome [18] 384707 0
Incidence of other COVID-19 related syndromes. Defined as evidence of myocarditis or myocardial ischaemia, neurological disease (including stroke), acute renal insufficiency and thromboembolism. Assessment of hospital medical records following notification of admission by participant or local General Practitioner.
Timepoint [18] 384707 0
28 days

Eligibility
Key inclusion criteria
1) Adults with PCR-confirmed COVID-19 (regardless of symptom status)
2) In one of two strata:
a) Participants aged 50 to 64 years with any of the following listed comorbidities:
- Coronary (ischaemic) heart disease
- Hypertension
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Diabetes
- Previous stroke
- Active cancer
- On immunosuppressive therapy: long-term oral steroids (equivalent to prednisone
20mg daily or greater) or other long-term immunosuppression.
OR
b) Participants aged 65 years and older (regardless of comorbidity)

3) Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
4) Documented informed consent, either written or e-consent.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Hypoxaemia (SpO2 < 94% on room air)
2) Resting HR > 110 bpm
3) Systolic BP < 90 mmHg
4) Pregnancy or lactation.
5) Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
6) If there are definite indications or contraindications to any of the study medications in the view of the doctor responsible for the care of the patient

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation
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
Intervention assignment
Parallel
Other design features
Bayesian adaptive randomisation platform controlled trial
Phase
Phase 3
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305694 0
University
Name [1] 305694 0
NHMRC Clinical Trials Centre, University of Sydney
Address [1] 305694 0
Medical Foundation Building
Levels 4-6, 92-94 Parramatta Rd
Camperdown NSW 2050
Country [1] 305694 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Western Avenue,
Camperdown
Sydney
New South Wales 2006

Country
Australia
Secondary sponsor category [1] 306110 0
None
Name [1] 306110 0
Address [1] 306110 0
Country [1] 306110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305972 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305972 0
Level 11, KGV Building Missenden Road. CAMPERDOWN NSW 2050
Ethics committee country [1] 305972 0
Australia
Date submitted for ethics approval [1] 305972 0
20/05/2020
Approval date [1] 305972 0
24/07/2020
Ethics approval number [1] 305972 0

Summary
Brief summary
The aim of this study is to rapidly and efficiently establish the best treatments for high risk older 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, and you are aged 65 years or more, OR are aged 50-64 years and suffer from any of the following co-morbidities: coronary (ischaemic) heart disease, hypertension, asthma, chronic obstructive pulmonary disease (COPD), diabetes, previous stroke, active cancer, immunosuppression.

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102262 0
Prof Guy Marks
Address 102262 0
Woolcock Institute of Medical Research
431 Glebe Point Road, Glebe New South Wales 2037
Country 102262 0
Australia
Phone 102262 0
+61 02 9114 0000
Fax 102262 0
Email 102262 0
g.marks@unsw.edu.au
Contact person for public queries
Name 102263 0
Ms Kate Wilson
Address 102263 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450 Australia
Country 102263 0
Australia
Phone 102263 0
+61 02 9562 5000
Fax 102263 0
Email 102263 0
kwilson@ctc.usyd.edu.au
Contact person for scientific queries
Name 102264 0
Prof Guy Marks
Address 102264 0
Woolcock Institute of Medical Research
431 Glebe Point Road, Glebe New South Wales 2037
Country 102264 0
Australia
Phone 102264 0
+61 02 9114 0000
Fax 102264 0
Email 102264 0
g.marks@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
to be confirmed
What supporting documents are/will be available?
No other documents available
Summary results
No Results