Thinking and Practice in the Design of Clinical Trial Schemes for the Treatment of COVID-19 with Traditional Chinese Medicine: A Study Protocol

Abstract

Background and objectives: This study aimed to determine the key points in the design of clinical trial protocols for coronavirus disease 2019 (COVID-19) following the PICOS principle. Methods: A randomized, double-blind, placebo-controlled study of Cangma Huadu Granules in the treatment of mild COV-ID-19 will be carried out. Discussion: We recommend a randomized controlled trial as the study type. The inclusion criteria should not only define the diagnostic criteria of Western medicine and the syndrome types of Chinese medicine but also define the course of the disease. The definition of high-risk groups in the exclusion criteria needs to specify the diseases and laboratory test indicators to avoid excluding patients with common underlying diseases. Preclinical studies on the experimental product and the traditional Chinese medicine theory of indications should be outlined to clarify the trial rationale. A placebo combined with basic treatment is recommended as a control. Outcomes can refer to the core outcome set for clinical trials on COVID-19, and it is recommended to set the main outcome indicators around the clinical symptoms. In addition, homogeneous Chinese medicine during the ex-periment should be avoided, and the online registration should be completed in a timely manner. Trial Registration