虽然新型冠状病毒肺炎 （COVID-19） 紧急状态已结束 ， 但新型冠状病毒 （SARS-CoV-2） 还在继续传播 ，COVID-19 对某些人来说仍然是严重的健康风险。为促进开发治疗和预防 COVID-19 的药物和生物制品，FDA 于 2024 年 2 月发布了“在 COVID-19 预防或治疗药物和生物制品临床试验中，门诊成人和青少年受试者的 COVID-19 相关症状评估供企业用的指导原则”。该指导原则讨论了这种门诊临床试验中，检测和分析 COVID-19 相关常见症状的方法，包括一般建议；主要症状的示例评估；试验终点选择；数据处理和其他相关的评估。而我国目前还没有类似的指导原则，详细介绍该指导原则，期望对我国这类研究和监管有启示。

Although the COVID-19 emergency has ended, SARS-CoV-2 continues to circulate, and COVID-19 remains a serious health risk for some individuals. FDA issued the "Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry" in February 2024 to facilitate the development of drugs and biological products for the treatment and prevention of COVID-19. This guideline discusses the approaches for measurement and analysis of common symptoms associated with COVID-19 in this outpatient clinical trial, including general recommendations, example assessment of key symptoms, trial endpoint selection, handling data and additional related assessments. However, there is currently no similar guidance in China.This article provides a detailed introduction to this guidance, hoping to provide inspiration for research and regulation in this field in China.

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