Abstract:
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Response to the COVID-19 pandemic drove rapid implementation of innovative clinical trials for non-vaccine biomedical prevention of SARS-CoV-2 acquisition and progression to COVID-19 both for repurposed and novel biomedical interventions. Pre-Exposure Prophylactic (PrEP) and Post-Exposure Prophylactic (PEP) interventions have both been evaluated in an effort to find a non-vaccine biomedical intervention to stop the spread of SARS-CoV-2. Statistical design of these studies was challenging due to several factors, including lack of data on transmission risk, variability in demographics and geography over time leading to uncertainty in identifying high risk groups, potential contamination due to secondary intervention effects, uncertainty about the primary outcome and a potentially rapidly changing intervention landscape. In this presentation, we will review designs statistical properties of COVID-19 PrEP and PEP studies, exploring the approaches taken to overcome the challenges listed above.
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