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

BEAT COVID-19 Participant Notification

Due to the availability of new evidence, a decision was made to close enrolment to the part of this study where a corticosteroid inhaler was tested. Enrolment of new participants to the BEAT COVID-19 inhaler group (Cicelsonide Domain) was stopped on September 26, 2023.

The decision was in response to the results of another similar study recently published in the New England Journal of Medicine, which demonstrated that the type of medication that we are testing does not reduce the severity of respiratory events of COVID-19 or the need for urgent care. And therefore, the researchers concluded that recruiting more participants to our relatively smaller study will not have a significant impact on the conclusions already made.

Overall, 195 out of the planned 250 participants were enrolled. The number of patients who agreed to participate was commendable and we thank you for your participation. The burden of respiratory disease in people with BEAT COVID-19 remains an important unanswered question and the data collected from this trial will still be used and analysed as planned per the BEAT COVID-19 Cicelsonide Domain Participant Information Sheet.

If you were or are a participant on the study, there are no other changes to the information that you have previously agreed to, and you can contact your study trial team if you wish to discuss any other aspects of the study.

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.