Azvudine was included into the Guidelines for the Diagnosis and Treatment of Coronavirus Disease 2019 (version ninth) issued by the National Health Commission and National Administration of Traditional Chinese Medicine announced on August 9, 2022. Numerous domestic public hospitals introduced Azvudine to copy with the current omicron wave of the COVID-19 pandemic by the end of 2022. In the study, we comprehensively evaluated the efficacy and safety of Azvudine using the clinical data from four phase Ⅲ clinical trials.