Hanshiyi Formula treatment in patients with COVID-19: study protocol and statistical analysis plan (SAP) of an open-label randomized controlled clinical trial

Abstract

Background As COVID-19 continues to spread rapidly in 2019, the risks to human health cannot be underestimated. There is still lack of antiviral drugs for COVID-19, and the development of effective treatments is urgent. Traditional Chinese Medicine (TCM) has been widely used in the treatment of epidemic infectious diseases, The purpose of this randomized controlled clinical trial will to evaluate the clinical efficacy and safety of Hanshiyi Formula (HSYF) in patients with COVID-19. Methods We will conduct this randomized, controlled, open, non-inferiority test clinical study in 240 COVID-19 subjects. Eligible patients will be divided into a control group ( LH granule ) or a treatment group ( HSYF ) in a 1:1 ratio. The intervention duration will be 14 days, and the medication could be stopped in advance if the discharge standard was reached. Clinical efficacy measures will be analyzed at baseline and on day 1–14 of enrollment, The occurrence of adverse events will be monitored throughout the trial. The statistical analysis plan included the treatment of missing data, the analysis of outcome measures, and the method of safety endpoints. Discussion To investigate the efficacy and safety of HSYF in the treatment of COVID-19, provide more sufficient high-quality evidence-based medical basis for TCM intervention in the diagnosis and treatment of COVID-19. To avoid selective reporting bias and data-driven analysis, the statistical analysis plan will standardize the statistical analysis of clinical trials. Trial registration: Chinese Clinical Trial Registry, ChiCTR2200058384. Version V1.2, created on April 11, 2022.https://www.chictr.org.cn/com/25/hvshowproject.aspx?id=159938.