Dataset Information

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

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 ).

SUBMITTER: Wang JB

PROVIDER: S-EPMC7364292 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Wang Jia-Bo JB Wang Zhong-Xia ZX Jing Jing J Zhao Peng P Dong Jing-Hui JH Zhou Yong-Feng YF Yang Guang G Niu Ming M Zhao Xu X Jiang Tian-Jun TJ Bi Jing-Feng JF Xu Zhe Z Zhang Ping P Wu Dan D Bai Zhao-Fang ZF Guo Yu-Ming YM Yu Si-Miao SM Sun Yong-Qiang YQ Zhang Zi-Teng ZT Zhan Xiao-Yan XY Li Peng-Yan PY Ding Jin-Biao JB Zhao Peng-Fei PF Song Xue-Ai XA Tang Jian-Yuan JY He Dong-Chu DC Chen Zhu Z Qin En-Qiang EQ Wang Rui-Lin RL Xiao Xiao-He XH

Chinese journal of integrative medicine 20200716 9

<h4>Objectives</h4>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.<h4>Methods</h4>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) an ...[more]

PMID: 32676976

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Dataset Information

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

Objectives

Methods

Results

Conclusions

Publications

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

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