Operating characteristics of analysis methods for clinical trials in viral respiratory disease: A simulation study protocol

Acute viral respiratory infections (ARVIs) are a major cause of hospitalization and death worldwide, yet randomized clinical trials in this setting face substantial challenges in selecting efficient and clinically meaningful primary endpoints. Mortality is often too infrequent to serve as a feasible primary endpoint. Several alternative approaches have been proposed, including ordinal scales, time-to-event endpoints, recovery-based composite outcomes, and longitudinal ordinal models. However, their comparative operating characteristics under realistic ARVI disease courses remain insufficiently understood. We describe a simulation study to compare the type I error and power of commonly used a