The Efficacy of Treating Pulmonary Fibrosis and Pulmonary Function Injury in COVID-19 with Fuzheng Huayu Tablets: Study Protocol for a Multicenter Randomized Controlled Trial

Abstract

Introduction: The patients with COVID-19 could be suffered from pulmonary dysfunction and/or fibrosis in recovery period, but there are no certain drugs or treatment to cope with this situation. Our previous studies indicated that Fuzheng Huayu tablets (FZHY) could regress lung fibrosis induced by bleomycin in animals, and improve pulmonary function in patients with chronic obstructive pulmonary disease. Now we design this trial in order to evaluate the effects of FZHY on pulmonary fibrosis and/or pulmonary function injury in the recovery period of COVID-19 and expect to improve the prognosis. \n \nMethods and analysis: This is a randomized, double-blinded, multicenter, placebo-controlled clinical trial from March 1, 2020 to December 31, 2021. 160 patients who had been diagnosed with COVID-19 were enrolled, but currently they are negative in viral test and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly assigned into control group and experimental group. All patients are given basic treatment such as respiratory function rehabilitation training and vitamin C. The experimental group is given FZHY meanwhile the control group is given placebo. Each patient will be observed for 24 weeks and followed up for 8 weeks. The primary outcome of this trial is the improvement proportion of lung fibrosis judged by HRCT score. Secondary outcomes include six-minute walk distance, clinical symptoms score, oxygen saturation, quality of Life-BREF Score, patient health questionnaire-9 Score and general anxiety disorder-7 score. The safety will also be observed. \n \nEthics and dissemination: This study has been approved by the IRB of Shuguang Hospital affiliated with Shanghai University of TCM. The results will be presented at national as well as international conferences.