A BayEsian Adaptive platform, randomised controlled Trial to evaluate the efficacy and safety of interventions for COVID-19 (BEAT-COVID-19)

 

Background:

Coronavirus disease 2019 (COVID-19) is a recent and one of the deadliest examples of cross-species viral transmission affecting the human population. By the end of July 2021, COVID-19 has resulted in more than 190 million confirmed cases and 4.1 million confirmed deaths worldwide. Its clinical spectrum is broad, ranging from asymptomatic infection to respiratory failure, multi-organ dysfunction, and death.

 

Research Methodology:

BEAT COVID-19 is an investigator-initiated, multicentre, prospective, adaptive, platform, randomised controlled trial. The platform has been designed and delivered in partnership with Royal Prince Alfred Virtual Hospital.

In this platform trial, multiple treatments across diverse domains of therapeutic care will be assessed within the same trial infrastructure. This provides the most efficient structure for evidence generation in this setting. BEAT COVID-19 will initiate with one active domains;

  1. Ciclesonide Domain, which aims to investigate whether treatment with different corticosteroid inhaler is superior to placebo in preventing worsening outcomes.

As an adaptive platform trial, additional domains of care, and additional interventions within existing domains, will be introduced into the platform as they become scientifically and operationally feasible.

 

Aim:

The aim of the platform is to accelerate the evaluation and implementation of treatments to reduce the burden of morbidity and mortality due to severe respiratory disease in people with SARS-COV-2 infection.

Supported By:

Australian Medical Research Future Fund (MRFF) 2018 Rare Cancers, Rare Disease and Unmet Need Grant commencing 2018

Eligibility:

 Platform inclusion criteria:

  1. Adult, aged ≥ 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

Platform 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

Note:

  1. Participation in another clinical trial does not preclude enrolment in this trial unless that trial involves interventions that are restricted for this trial.
  2. Additional eligibility criteria exist for participation within each recruiting domain.

Registration ID:

ACTRN12620000566932

Participation:

Australia

Australian Lead Group:

NHMRC CTC

Status:

Active, Recruiting

Activation Date:

2021

Chair:

Professor Guy Marks

Contact:

beatcovid19.study@sydney.edu.au

Publications:

Nil to date