The Efficacy of Treating Pulmonary Fibrosis and Pulmonary Function Injury in COVID-19 with the Fuzheng Huayu Tablets: study protocol for a multicenter randomized controlled trial
Abstract Background: Some patients with COVID-19 have been found pulmonary dysfunction and/or fibrosis in the recovery period, especially severe cases, but there are no certain drugs or treatment to cope with this situation. Previous studies proved the efficacy of FZHY on lung fibrosis induced by Bleomycin in animals and improvement of pulmonary function in COPD patients. We design this trial to carry out the clinical study that the effects of FZHY Tablets on pulmonary fibrosis and/or pulmonary function injury in the recovery period of COVID-19 and expect to improve the prognosis.Methods/design: This is a double-blind, placebo-controlled, randomized, multicenter clinical trial. It enrolls 160 patients who had been diagnosed with COVID-19, but currently they are negative for viral testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly divided equally into control group and experimental group. All patients are given basic treatment such as respiratory function rehabilitation training and vitamin C. The control group is given placebo of FZHY, and the experimental group is given FZHY. Each patient will be observed for 24 weeks and followed up for 8 weeks. The primary outcome for the trial is a composite endpoint consisting of lung function and HRCT. Secondary outcomes include clinical symptoms, oxygen saturation and quality of life assessment. Discussion: The trial is designed to test the hypothesis that treating pulmonary fibrosis or pulmonary dysfunction after SARS-CoV-2 infection with FZHY will improve the patient’s lung function or the pathological manifestation of pulmonary fibrosis, and improve the quality of life. Trial registration: Clinical Trials.gov, ID: NCT04279197. Registered on 12 April 2020.