Overview
About BEAT COVID-19 Study
The BEAT COVID-19 Study is a randomised clinical trial of interventions for the treatment of COVID-19 in high risk, older people who are living in the community or in aged care facilities. For this study, high risk people are those aged 65 and older and also those aged 50 to 64 years who have pre-existing chronic diseases.
This NSW-led randomised platform clinical trial provides a purpose-built durable framework for the COVID-19 pandemic that will rapidly and efficiently establish the evidence-base required to prevent deaths and mitigate severe morbidity.
Using a specialist methodology called Bayesian adaptive randomisation and analysis, the BEAT-COVID-19 Study will, through frequent and continuous analyses of study patient data and assessment of other COVID-19 trial outcomes, be positioned to:
- 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;
- Ensure rapid implementation of new treatments; and
- Allow effectiveness and safety to be regularly compared at any point in the trial to support continuous learning and real-time decision-making.
About COVID-19
COVID-19 is caused by a novel coronavirus, SARS-CoV2. Hence, there is little empirical data on which to base the interventions for prevention and treatment. Initial decisions have been based on analogy with similar viruses (such as SARS, MERS and influenza) and other infections. Over time this is being augmented by publication of case reports, case series and small-scale and then larger clinical trials. COVID-19 is an acute viral respiratory illness that, for the majority of infected individuals, runs a benign, self-limited course characterised by upper respiratory tract, cough and systemic symptoms. Clinical intervention for these episodes may not be required, apart from simple supportive measures. A small proportion of people with COVID-19 will become severely ill and are hospitalised.
Potential Treatments / Interventions
Currently, there is no proven effective therapy for COVID-19, in particular for older people with comorbidities who are managing their infection at home. 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.
Randomised Clinical Trials
This is a randomised controlled study. Sometimes it is not known which treatment is best for treating a condition and testing treatments in clinical trials involves putting people into groups and giving each group a different treatment and then comparing the results to see if one is better.
To try to make sure the groups are the same, each participant is put into a group by chance (this is called randomisation). Participants will have an equal chance of receiving either an active study treatment or placebo (that is, a medication with no active ingredients). Neither the participant nor their doctor can choose the treatment that is individually allocated.
Collaboration with other COVID-19 studies
We have designed the BEAT COVID-19 study to harmonise with the UK PRINCIPLE study. This collaboration will:
(i) give greater power, and
(ii) allow earlier identification of effective / safe treatments which would lead to timelier implementation of adaptive randomisation decisions based on the data from both studies.
Find out more about PRINCIPLE study.