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
4/08/2024
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.
Scientific title
BEAT COVID-19: A Bayesian adaptive platform, randomised controlled Trial to evaluate the efficacy and safety of interventions for COVID-19.
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
Condition category
Condition code
Infection 315518 315518 0 0
Other infectious diseases

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. 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.
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
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.
Timepoint [1] 323760 0
28 days
Secondary outcome [1] 382797 0
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.
Timepoint [1] 382797 0
28 days
Secondary outcome [2] 382798 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. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
Timepoint [2] 382798 0
28 days
Secondary outcome [3] 382799 0
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.
Timepoint [3] 382799 0
28 days
Secondary outcome [4] 382800 0
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.
Timepoint [4] 382800 0
28 days
Secondary outcome [5] 382801 0
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.
Timepoint [5] 382801 0
28 days
Secondary outcome [6] 382802 0
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.
Timepoint [6] 382802 0
28 days
Secondary outcome [7] 382803 0
Incidence of mechanical ventilation. Derived from assessment of hospital medical records following notification of admission by participant, study team or local General Practitioner.
Timepoint [7] 382803 0
28 days
Secondary outcome [8] 382804 0
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.
Timepoint [8] 382804 0
28 days
Secondary outcome [9] 382806 0
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.
Timepoint [9] 382806 0
28 days
Secondary outcome [10] 382808 0
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.
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
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.
Secondary outcome [12] 382812 0
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.
Timepoint [12] 382812 0
28 days
Secondary outcome [13] 382813 0
Occurrence of participant hospitalisation during symptomatic COVID-19 during the first 28 days after randomisation.
Timepoint [13] 382813 0
28 days.
Secondary outcome [14] 382894 0
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.
Timepoint [14] 382894 0
28 days.
Secondary outcome [15] 382927 0
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.
Timepoint [15] 382927 0
28 days after randomisation.
Secondary outcome [16] 382928 0
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).
Timepoint [16] 382928 0
3 and 6 months after randomisation
Secondary outcome [17] 384706 0
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
Timepoint [17] 384706 0
3 and 6 months after randomisation.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
25/10/2021
Actual
16/03/2022
Date of last participant enrolment
Anticipated
31/10/2023
Actual
26/09/2023
Date of last data collection
Anticipated
29/12/2023
Actual
19/03/2024
Sample size
Target
250
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20722 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 24459 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 35528 0
2050 - Camperdown
Recruitment postcode(s) [2] 40041 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 309902 0
Government body
Name [1] 309902 0
NSW Ministry of Health
Country [1] 309902 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 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102262 0
Prof Guy Marks
Address 102262 0
University of New South Wales
Sydney NSW 2052
Country 102262 0
Australia
Phone 102262 0
+61 02 8738 3000
Fax 102262 0
Email 102262 0
[email protected]
Contact person for public queries
Name 102263 0
Ms Karen Allison
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
[email protected]
Contact person for scientific queries
Name 102264 0
Guy Marks
Address 102264 0
University of New South Wales
Sydney NSW 2052
Country 102264 0
Australia
Phone 102264 0
+61 02 8738 3000
Fax 102264 0
Email 102264 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
to be confirmed


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.