Xiaolong Xu1, Junhua Zhang2, Wenke Zheng2, Zifeng Yang3, Xuegong Zhao4, Changfeng Wang5, Hongzheng Su6, Li Zhao7, Leyang Xue8, Fen Hu9, Xiaohong Xu10, Minyong Wen11, Jiong Liao12, Zhaohai Zeng13, Liping Wang14, Jiaqing Zeng15, Yuhong Guo1, Bo Li1, Qingquan Liu16. 1. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Traditional Chinese Medicine, Beijing, China. 2. Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China. 3. Guangzhou Institute of Respiratory Diseases, Guangzhou, China. 4. The Third Hospital of Yichang, Yichang, China. 5. Huanggang Central Hospital, Huanggang, China. 6. People's Hospital of Zaoyang, Zaoyang, China. 7. The Fourth People's Hospital of Lianyungang, Lianyungang, China. 8. Huai'an Fourth People's Hospital, Huai'an, China. 9. The First People's Hospital of Jiangxia District of Wuhan City, Wuhan, China. 10. People's Hospital of Hanchuan, Hanchuan, China. 11. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. 12. People's Hospital of Laibin, Laibin, China. 13. People's Hospital of Guangshan County, Xinyang, China. 14. The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. 15. The First People's Hospital of Laohekou, Laohekou, China. 16. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Traditional Chinese Medicine, Beijing, China. liuqingquan2003@126.com.
Abstract
BACKGROUND:Reduning injection is a traditional Chinese medicine (TCM) with known efficacy against a variety of viral infections, but there is no data about its efficacy against coronavirus disease 2019 (COVID-19). METHODS: To explore the efficacy and safety of Reduning injection in the treatment of COVID-19, a randomized, open-labeled, multicenter, controlled trial was conducted from 12 general hospitals between 2020.02.06 and 2020.03.23. Patients with COVID-19 who met the diagnostic criteria of the "Diagnosis and Treatment Program for Novel Coronavirus Infection Pneumonia (Trial Fifth Edition)". Patients were randomized to routine treatment with or without Reduning injection (20 mL/day for 14 days) (ChiCTR2000029589). The primary endpoint was the rate of achieving clinical symptom recovery on day 14 of treatment. RESULTS: There were 77 and 80 participants in the Reduning and control groups. The symptom resolution rate at 14 days was higher in the Reduning injection than in controls [full-analysis set (FAS): 84.4% vs. 60.0%, P=0.0004]. Compared with controls, the Reduning group showed shorter median time to resolution of the clinical symptoms (143 vs. 313.5 h, P<0.001), shorter to nucleic acid test turning negative (146.5 vs. 255.5 h, P<0.001), shorter hospital stay (14.1 vs. 18.1 days, P<0.001), and shorter time to defervescence (29 vs. 71 h, P<0.001). There was no difference in AEs (3.9% vs. 8.8%, P=0.383). CONCLUSIONS: This preliminary trial suggests that Reduning injection might be effective and safe in patients with symptomatic COVID-19.
RCT Entities:
BACKGROUND: Reduning injection is a traditional Chinese medicine (TCM) with known efficacy against a variety of viral infections, but there is no data about its efficacy against coronavirus disease 2019 (COVID-19). METHODS: To explore the efficacy and safety of Reduning injection in the treatment of COVID-19, a randomized, open-labeled, multicenter, controlled trial was conducted from 12 general hospitals between 2020.02.06 and 2020.03.23. Patients with COVID-19 who met the diagnostic criteria of the "Diagnosis and Treatment Program for Novel Coronavirus Infection Pneumonia (Trial Fifth Edition)". Patients were randomized to routine treatment with or without Reduning injection (20 mL/day for 14 days) (ChiCTR2000029589). The primary endpoint was the rate of achieving clinical symptom recovery on day 14 of treatment. RESULTS: There were 77 and 80 participants in the Reduning and control groups. The symptom resolution rate at 14 days was higher in the Reduning injection than in controls [full-analysis set (FAS): 84.4% vs. 60.0%, P=0.0004]. Compared with controls, the Reduning group showed shorter median time to resolution of the clinical symptoms (143 vs. 313.5 h, P<0.001), shorter to nucleic acid test turning negative (146.5 vs. 255.5 h, P<0.001), shorter hospital stay (14.1 vs. 18.1 days, P<0.001), and shorter time to defervescence (29 vs. 71 h, P<0.001). There was no difference in AEs (3.9% vs. 8.8%, P=0.383). CONCLUSIONS: This preliminary trial suggests that Reduning injection might be effective and safe in patients with symptomatic COVID-19.
Entities:
Keywords:
Coronavirus disease 2019 (COVID-19); efficacy and safety; randomized controlled trial; traditional Chinese medicine (TCM)