Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Apr 22, 2020
Date Accepted: Jun 25, 2020
Date Submitted to PubMed: Jun 26, 2020
Statistical Issues and Lessons Learned from COVID-19 Clinical Trials with Lopinavir-Ritonavir and Remdesivir
ABSTRACT
The LOTUS China (Lopinavir Trial for Suppression of SARS-Cov-2 in China) trial concluded no benefit with the lopinavir–ritonavir treatment beyond the standard care in adults hospitalized with severe COVID-19. We reanalyze the data from the trial using a terminal (or cure) rate model and a model-free metric known as the restricted mean survival time (or the restricted mean time to improvement in this context). Our more in-depth and comprehensive analysis yield new insights on the design and analysis for future and ongoing COVID-19 clinical trials.
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