Remap-cap: Delivering research in the pandemic

ABSTRACT

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) pandemic is an unprecedented global health crisis. For hospitalised patients with Coronavirus Disease 2019 (COVID-19) mortality and morbidity is high. A case fatality rate of 49% for critically ill patients was reported in early studies. We urgently need effective treatments for these patients. In past pandemics, the clinical research response has largely failed. During the Influenza A(H1N1) pandemic, no randomised trials delivered results. Traditional randomised trials are not well suited for research in pandemics. They are robust, but lack the flexibility to adapt to changing circumstances and only investigate a single treatment against a control arm. Additionally, sample size calculations are almost impossible in new diseases. Adaptive platform trials, specifically REMAP-CAP, help overcome the challenges of pandemic research. We describe the key design principles of adaptive platform trials, the design of REMAP-CAP, and how this trial has delivered important results that contribute to the treatment of hospitalised and critically ill patients with COVID-19.