Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.
10.1007/s11655-020-3426-7
- Author:
Jia-Bo WANG
1
;
Zhong-Xia WANG
2
;
Jing JING
2
;
Peng ZHAO
3
;
Jing-Hui DONG
4
;
Yong-Feng ZHOU
1
;
Guang YANG
3
;
Ming NIU
1
;
Xu ZHAO
1
;
Tian-Jun JIANG
3
;
Jing-Feng BI
5
;
Zhe XU
3
;
Ping ZHANG
1
;
Dan WU
3
;
Zhao-Fang BAI
1
;
Yu-Ming GUO
1
;
Si-Miao YU
2
;
Yong-Qiang SUN
2
;
Zi-Teng ZHANG
1
;
Xiao-Yan ZHAN
1
;
Peng-Yan LI
1
;
Jin-Biao DING
5
;
Peng-Fei ZHAO
6
;
Xue-Ai SONG
2
;
Jian-Yuan TANG
7
;
Dong-Chu HE
8
;
Zhu CHEN
9
;
En-Qiang QIN
10
;
Rui-Lin WANG
11
;
Xiao-He XIAO
12
Author Information
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. Department of Radiology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
5. Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
6. College of Life Science, Beijing University of Chinese Medicine, Beijing, 100029, China.
7. Sichuan Evidence-Based Medicine Center of Traditional Chinese Medicine Affliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
8. Department of Integrated Treatment, General Hospital of Central Theater Command, Wuhan, 430070, China.
9. National Clinical Research Center for Infectious Diseases, Beijing, 100039, 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. Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. wrl7905@163.com.
12. China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. pharmacy302xxh@126.com.
- Publication Type:Journal Article
- Keywords:
COVID-19;
Chinese medicine;
SARS-CoV-2;
acute respiratory distress syndrome
- MeSH:
Administration, Inhalation;
Adult;
China;
Coronavirus Infections;
diagnosis;
drug therapy;
mortality;
Dose-Response Relationship, Drug;
Drug Administration Schedule;
Drugs, Chinese Herbal;
administration & dosage;
Female;
Follow-Up Studies;
Humans;
Integrative Medicine;
Interferon-alpha;
administration & dosage;
Lopinavir;
administration & dosage;
Male;
Middle Aged;
Pandemics;
Pneumonia, Viral;
diagnosis;
drug therapy;
mortality;
Risk Assessment;
Severe Acute Respiratory Syndrome;
diagnosis;
drug therapy;
mortality;
Severity of Illness Index;
Survival Rate
- From:
Chinese journal of integrative medicine
2020;26(9):648-655
- CountryChina
- Language:English
-
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 ).
