Zhen-Hui Lu1, Chun-Li Yang2, Gai-Ge Yang3, Wen-Xu Pan4, Li-Guang Tian5,6, Jin-Xin Zheng5,6, Shan Lv5,6, Shao-Yan Zhang1, Pei-Yong Zheng7, Shun-Xian Zhang8,9. 1. Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shangha, 200032, People's Republic of China. 2. The 903Rd Hospital of People's Liberation Army of China, Hangzhou, 310013, People's Republic of China. 3. Guangzhou Women and Children's Medical Center, Guangzhou, 510623, People's Republic of China. 4. The First Affiliated Hospital of Jinan University, Jinan University, Guangzhou, 510632, People's Republic of China. 5. National Institute of Parasitic DiseasesChinese Center for Disease Control and PreventionChinese Center for Tropical Diseases ResearchKey Laboratory of Parasite and Vector BiologyMinistry of HealthNational Center for International Research On Tropical DiseasesMinistry of Science and Technology, WHO Collaborating Center for Tropical Diseases, Shanghai, 200025, People's Republic of China. 6. School of Global Health, Chinese Center for Tropical Diseases Research-Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, People's Republic of China. 7. Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shangha, 200032, People's Republic of China. zpychina@sina.com. 8. National Institute of Parasitic DiseasesChinese Center for Disease Control and PreventionChinese Center for Tropical Diseases ResearchKey Laboratory of Parasite and Vector BiologyMinistry of HealthNational Center for International Research On Tropical DiseasesMinistry of Science and Technology, WHO Collaborating Center for Tropical Diseases, Shanghai, 200025, People's Republic of China. zhangshunxian110@163.com. 9. School of Global Health, Chinese Center for Tropical Diseases Research-Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, People's Republic of China. zhangshunxian110@163.com.
Abstract
BACKGROUND: The coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has led to a significant number of mortalities worldwide. COVID-19 poses a serious threat to human life. The clinical manifestations of COVID-19 are diverse and severe and 20% of infected patients are reported to be in a critical condition. A loss in lung function and pulmonary fibrosis are the main manifestations of patients with the severe form of the disease. The lung function is affected, even after recovery, thereby greatly affecting the psychology and well-being of patients, and significantly reducing their quality of life. METHODS: Participants must meet the following simultaneous inclusion criteria: over 18 years of age, should have recovered from severe or critical COVID-19 cases, should exhibit pulmonary fibrosis after recovery, and should exhibit Qi-Yin deficiency syndrome as indicated in the system of traditional Chinese medicine (TCM). The eligible candidates will be randomized into treatment or control groups. The treatment group will receive modern medicine (pirfenidone) plus TCM whereas the control group will be administered modern medicine plus TCM placebo. The lung function index will be continuously surveyed and recorded. By comparing the treatment effect between the two groups, the study intend to explore whether TCM can improve the effectiveness of modern medicine in patients with pulmonary fibrosis arising as a sequelae after SARS-CoV-2 infection. DISCUSSION: Pulmonary fibrosis is one of fatal sequelae for some severe or critical COVID-19 cases, some studies reveal that pirfenidone lead to a delay in the decline of forced expiratory vital capacity, thereby reducing the mortality partly. Additionally, although TCM has been proven to be efficacious in treating pulmonary fibrosis, its role in treating pulmonary fibrosis related COVID-19 has not been explored. Hence, a multicenter, parallel-group, randomized controlled, interventional, prospective clinical trial has been designed and will be conducted to determine if a new comprehensive treatment for pulmonary fibrosis related to COVID-19 is feasible and if it can improve the quality of life of patients. TRIAL REGISTRATION: This multicenter, parallel-group, randomized controlled, interventional, prospective trial was registered at the Chinese Clinical Trial Registry (ChiCTR2000033284) on 26th May 2020 (prospective registered).
RCT Entities:
BACKGROUND: The coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has led to a significant number of mortalities worldwide. COVID-19 poses a serious threat to human life. The clinical manifestations of COVID-19 are diverse and severe and 20% of infectedpatients are reported to be in a critical condition. A loss in lung function and pulmonary fibrosis are the main manifestations of patients with the severe form of the disease. The lung function is affected, even after recovery, thereby greatly affecting the psychology and well-being of patients, and significantly reducing their quality of life. METHODS:Participants must meet the following simultaneous inclusion criteria: over 18 years of age, should have recovered from severe or critical COVID-19 cases, should exhibit pulmonary fibrosis after recovery, and should exhibit Qi-Yin deficiency syndrome as indicated in the system of traditional Chinese medicine (TCM). The eligible candidates will be randomized into treatment or control groups. The treatment group will receive modern medicine (pirfenidone) plus TCM whereas the control group will be administered modern medicine plus TCM placebo. The lung function index will be continuously surveyed and recorded. By comparing the treatment effect between the two groups, the study intend to explore whether TCM can improve the effectiveness of modern medicine in patients with pulmonary fibrosis arising as a sequelae after SARS-CoV-2 infection. DISCUSSION: Pulmonary fibrosis is one of fatal sequelae for some severe or critical COVID-19 cases, some studies reveal that pirfenidone lead to a delay in the decline of forced expiratory vital capacity, thereby reducing the mortality partly. Additionally, although TCM has been proven to be efficacious in treating pulmonary fibrosis, its role in treating pulmonary fibrosis related COVID-19 has not been explored. Hence, a multicenter, parallel-group, randomized controlled, interventional, prospective clinical trial has been designed and will be conducted to determine if a new comprehensive treatment for pulmonary fibrosis related to COVID-19 is feasible and if it can improve the quality of life of patients. TRIAL REGISTRATION: This multicenter, parallel-group, randomized controlled, interventional, prospective trial was registered at the Chinese Clinical Trial Registry (ChiCTR2000033284) on 26th May 2020 (prospective registered).
Entities:
Keywords:
COVID-19; Modern medicine; Pulmonary fibrosis; SASR-CoV-2; Traditional Chinese medicine
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