Sarah Zohar, of the National Institute for Health and Medical Research (INSERM), Paris, France, will present:

“Sharing the Experience of Two Embedded Clinical Trials During COVID-19 Pandemic, Raising the Questions; If, When and How to Restart Temporarily Stopped Clinical Trials?”

Abstract: The Covid-19 pandemic appeared while we were conducting a large randomized trial assessing the effectiveness of corticosteroids in severe community-acquired pneumonia (Cape-Cod trial). Unexpectedly, Covid-19 infected patients were also included in this study. This is why, we took advantage of this ongoing trial to embed a sub-trial assessing in SARS-CoV-2 infected patients. In this presentation, we wish to share our experience about methodological choices impacting both trials; when we needed to make fast and robust decisions and re-designing this study during the Covid-19 pandemic in a two weeks period of time. Moreover, as Cape-Cod trial was temporarily stopped, today, we wonder when and how to restart this trial. Based on this experience, we will address several questions regarding how Covid-19 impacted on-going trials and when to restart (if possible) these studies avoiding scientific research waste.

All are welcome.