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)
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Acknowledgements
The authors acknowledge Academician WANG Fu-sheng for his advice to the trial.
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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.
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None declared.
Data Sharing Statements
See Appendix 10.
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)
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Wang, Jb., Wang, Zx., Jing, J. et al. Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial. Chin. J. Integr. Med. 26, 648–655 (2020). https://doi.org/10.1007/s11655-020-3426-7
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DOI: https://doi.org/10.1007/s11655-020-3426-7