Abstract

Coronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus 2, has become a major public health event. In China, traditional Chinese medicine has played a crucial role in controlling epidemics. However, there is limited real-world evidence regarding the use of traditional Chinese medicine in routine clinical practice. The aim of this study is to analyze multi-center clinical record data during the epidemic; provide an in-depth description of traditional Chinese medicine application in coronavirus disease-2019 patients; and evaluate the effectiveness and economy of traditional Chinese medicine. This is a multicenter retrospective cohort study. Adult patients infected with severe acute respiratory syndrome coronavirus 2 will be included. We will use the observational medical outcomes partnership common data model to extract patient data from each hospital’s electronic medical record and convert the data contained in different observational databases into a common structured format with a common representation (terminology, vocabulary, and coding scheme) that can be directly imported into common statistical software such as Statistical Analysis Systems, R and others. The outcomes of treatment regimens (traditional Chinese medicine under the national protocols vs. without traditional Chinese medicine under the national protocols) in the two groups will be compared, including clinical efficacy, public health impact and other exploratory indicators. Statistical analysis included propensity score matching, meta-analysis and sensitivity analysis. In the face of coronavirus disease-2019, the national diagnosis and treatment protocol for patients provides differential traditional Chinese medicine treatment for different types of syndromes. Randomized controlled trials or retrospective studies of a single drug or formulation cannot fully reflect the efficacy and therapeutic advantages of traditional Chinese medicine in the real world. This study can evaluate the effectiveness and economy of traditional Chinese medicine treatment under the application scenario of national diagnosis and treatment protocols, fill the gap of real-world evidence on traditional Chinese medicine treatment of coronavirus disease-2019, and inspire the application of traditional Chinese medicine in the prevention and treatment of infectious diseases in the future.