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 RPAV 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.