The Center for Drug Evaluation (CDE) has published a list of Q&As regarding the non-clinical and clinical evaluation criteria for new antiviral drugs against emerging COVID-19 variants. The aim is to guide the scientific research, development, and evaluation of new COVID-19 drugs.<\/p>\n\n\n\n
Clinical Study Endpoint<\/strong>
For the primary efficacy endpoint of clinical studies in patients with mild or common COVID-19, the CDE notes that with the emergence of the Omicron variant, the pathogenicity has been weakened, and the proportion of patients progressing to severe or critical disease or dying is low. Therefore, proving a drug\u2019s ability to improve clinical outcomes is challenging. Consequently, improvement in clinical efficacy measures (such as time to sustained clinical recovery within an appropriate timeframe) may be considered as the primary efficacy endpoint, with virological measures serving as key secondary efficacy endpoints.<\/p>\n\n\n\n