Jia-Bo Wang1, Zhong-Xia Wang2, Jing Jing2, Peng Zhao3,4, Jing-Hui Dong5, Yong-Feng Zhou1, Guang Yang3, Ming Niu1, Xu Zhao1, Tian-Jun Jiang3, Jing-Feng Bi6, Zhe Xu3, Ping Zhang1, Dan Wu3, Zhao-Fang Bai1, Yu-Ming Guo1, Si-Miao Yu2, Yong-Qiang Sun2, Zi-Teng Zhang1, Xiao-Yan Zhan1, Peng-Yan Li1, Jin-Biao Ding6, Peng-Fei Zhao7, Xue-Ai Song2, Jian-Yuan Tang8, Dong-Chu He9, Zhu Chen4, En-Qiang Qin10,11, Rui-Lin Wang12, Xiao-He Xiao13,14. 1. China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. 2. Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. 3. Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. 4. National Clinical Research Center for Infectious Diseases, Beijing, 100039, China. 5. Department of Radiology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. 6. Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. 7. College of Life Science, Beijing University of Chinese Medicine, Beijing, 100029, China. 8. Sichuan Evidence-Based Medicine Center of Traditional Chinese Medicine Affliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. 9. Department of Integrated Treatment, General Hospital of Central Theater Command, Wuhan, 430070, China. 10. Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. qeq2004@sina.com. 11. National Clinical Research Center for Infectious Diseases, Beijing, 100039, China. qeq2004@sina.com. 12. Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. wrl7905@163.com. 13. China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. pharmacy302xxh@126.com. 14. Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. pharmacy302xxh@126.com.
Abstract
OBJECTIVES: To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients. METHODS: A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed. RESULTS: An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048). CONCLUSIONS:Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
RCT Entities:
OBJECTIVES: To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19patients. METHODS: A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19patients were assessed. RESULTS: An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048). CONCLUSIONS:Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Entities:
Keywords:
COVID-19; Chinese medicine; SARS-CoV-2; acute respiratory distress syndrome
Authors: Elisabeth D Riviello; Willy Kiviri; Theogene Twagirumugabe; Ariel Mueller; Valerie M Banner-Goodspeed; Laurent Officer; Victor Novack; Marguerite Mutumwinka; Daniel S Talmor; Robert A Fowler Journal: Am J Respir Crit Care Med Date: 2016-01-01 Impact factor: 21.405
Authors: Bei Yin; Yi-Ming Bi; Lu Sun; Jin-Zhu Huang; Jia Zhao; Jia Yao; An-Xiang Li; Xian-Zhe Wang; Guan-Jie Fan Journal: Front Public Health Date: 2021-07-08