Detection of significant antiviral drug effects on COVID-19 with reasonable sample sizes in randomized controlled trials: A modeling study.
Shoya IwanamiKeisuke EjimaKawang Su KimKoji NoshitaYasuhisa FujitaTaiga MiyazakiShigeru KohnoYoshitsugu MiyazakiShimpei MorimotoShinji NakaokaYoshiki KoizumiYusuke AsaiKazuyuki AiharaKoichi WatashiRobin N ThompsonKenji ShibuyaKatsuhito FujiuAlan S PerelsonShingo IwamiTakaji WakitaPublished in: PLoS medicine (2021)
In this study, we found that estimated association in observational studies can be biased due to large heterogeneity in viral dynamics among infected individuals, and statistically significant effect in randomized controlled trials may be difficult to be detected due to small sample size. The sample size can be dramatically reduced by recruiting patients immediately after developing symptoms. We believe this is the first study investigated the study design of clinical trials for antiviral treatment using the viral dynamics model.