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. 2020 Jul 16;26(9):648–655. doi: 10.1007/s11655-020-3426-7

Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial

Jia-bo Wang 1, Zhong-xia Wang 2, Jing Jing 2, Peng Zhao 3,4, Jing-hui Dong 5, Yong-feng Zhou 1, Guang Yang 3, Ming Niu 1, Xu Zhao 1, Tian-jun Jiang 3, Jing-feng Bi 6, 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 6, Peng-fei Zhao 8, Xue-ai Song 2, Jian-yuan Tang 7, Dong-chu He 9, Zhu Chen 4, En-qiang Qin 3,4,✉, Rui-lin Wang 2,✉, Xiao-he Xiao 1,2,✉
PMCID: PMC7364292  PMID: 32676976

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. NCT 04251871 at www.clinicaltrials.gov)

Electronic Supplementary Material

Supplementary material is available in the online version of this article at 10.1007/s11655-020-3426-7.

Keywords: COVID-19, SARS-CoV-2, acute respiratory distress syndrome, Chinese medicine

Supplementary Material

11655_2020_3426_MOESM1_ESM.pdf (698.9KB, pdf)

Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial

Acknowledgements

The authors acknowledge Academician WANG Fu-sheng for his advice to the trial.

Author Contributions

Wang JB, Wang ZX, and Jing J conducted the study and wrote the manuscript, they contributed equally to this work as co-first authors. Wang ZX, Jing J, Zhao P, Dong JH, Zhou YF, Yang G, Jiang TJ, Xu Z, Wu D, Sun YQ, Wang JB, He DC, and Chen Z collected data and provided technical assistance. Jing J, Yu SM, Niu M, Zhao X, Zhang P, Song XA, Bi JF, Bai ZF, Guo YM, Zhao X, Zhao PF, Tang JY, and Li PY analyzed data. Wang JB, Wang RL, Qin EQ, and Xiao XH initiated and oversaw the study.

Footnotes

Supported by the National Administration of Traditional Chinese Medicine Project (No. 2020ZYLCYJ05-1), the National Natural Science Foundation of China (Nos. 81630100, 81721002, 81930110), China PLA Biosecurity Project (No. 19SWAQ13), China PLA Emergency Project (BWS20J006) and the Beijing Administration of Traditional Chinese Medicine Project (Nos. YJ2020-03, SYFY202011)

Conflict of interest

None declared.

Data Sharing Statements

See Appendix 10.

Contributor Information

En-qiang Qin, Email: qeq2004@sina.com.

Rui-lin Wang, Email: wrl7905@163.com.

Xiao-he Xiao, Email: pharmacy302xxh@126.com.

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Associated Data

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Supplementary Materials

11655_2020_3426_MOESM1_ESM.pdf (698.9KB, pdf)

Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial

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