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Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience.


ABSTRACT: The Cape-Covid trial is an embedded clinical trial within the ongoing Cape-Cod trial. The Covid-19 pandemic appeared while we were conducting a randomized trial assessing the effectiveness of corticosteroids in severe community-acquired pneumonia. We took advantage of this ongoing trial to embed a sub-trial assessing hydrocortisone in SARS-CoV-2 infected patients. In this manuscript, we wish to share our experience when we needed to make fast and robust methodological decisions during the Covid-19 pandemic in a two weeks period of time.

SUBMITTER: Dequin PF 

PROVIDER: S-EPMC8008347 | biostudies-literature |

REPOSITORIES: biostudies-literature

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