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

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hinese Journal of Integrative Medicine

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Available online at link.springer.com/journal/11655 Journal homepage: www.cjim.cn/zxyjhen/zxyjhen/ch/index.aspx E-mail: [email protected]

Original Article

Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial WANG Jia-bo1, WANG Zhong-xia2, JING Jing2, ZHAO Peng3,4, DONG Jing-hui5, ZHOU Yong-feng1, YANG Guang3, NIU Ming1, ZHAO Xu1, JIANG Tian-jun3, BI Jing-feng6, XU Zhe3, ZHANG Ping1, WU Dan3, BAI Zhao-fang1, GUO Yu-ming1, YU Si-miao2, SUN Yong-qiang2, ZHANG Zi-teng1, ZHAN Xiao-yan1, LI Peng-yan1, DING Jin-biao6, ZHAO Peng-fei8, SONG Xue-ai2, TANG Jian-yuan7, HE Dong-chu9, CHEN Zhu4, QIN En-qiang3,4, WANG Rui-lin2, and XIAO Xiao-he1,2 Objectives: To develop a new Chinese medicine (CM)-based drug and to evaluate its safety ABSTRACT Objectives: 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 Conclusions:: Keguan-1-based integrative therapy was safe and reduction in the development of ARDS (P =0.048). Conclusions superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT 04251871 at www.clinicaltrials.gov) KEYWORDS COVID-19, SARS-CoV-2, acute ©The Chinese Journal of Integrated Traditional and Western respiratory distress syndrome, Chinese medicine Medicine Press and Springer-Verlag GmbH Germany, part of

In December 2019, a number of patients with a new type of pneumonia of unknown etiology were detected in Wuhan, China. (1) It was then soon determined that it was a new severe acute respiratory syndrome (SARS) that was caused by a new coronavirus, the SARS-CoV-2 virus. (2) The new pneumonia was later named the Novel 2019 Coronavirus or COVID-19.(3) In 2002–2003, another SARS-causing coronavirus, the SARS-CoV virus, caused one of the most deadly epidemics in recent history. The outbreak of SARS-CoV caused more than 8,000 reported cases and 774 deaths, with a case-fatality rate (CFR) of 7% in China.(4) Less than a d