Preprint Review Version 1 This version is not peer-reviewed

Chinese Clinical Studies for Pharmacological Treatments of Coronavirus Disease 2019 (COVID-19)

Version 1 : Received: 15 April 2020 / Approved: 16 April 2020 / Online: 16 April 2020 (13:47:49 CEST)

How to cite: Han, R.; Wang, Y.; Dabbous, M.; Liang, S.; Qiu, T.; Toumi, M. Chinese Clinical Studies for Pharmacological Treatments of Coronavirus Disease 2019 (COVID-19). Preprints 2020, 2020040279 (doi: 10.20944/preprints202004.0279.v1). Han, R.; Wang, Y.; Dabbous, M.; Liang, S.; Qiu, T.; Toumi, M. Chinese Clinical Studies for Pharmacological Treatments of Coronavirus Disease 2019 (COVID-19). Preprints 2020, 2020040279 (doi: 10.20944/preprints202004.0279.v1).

Abstract

Objectives: This study aims to identify, report, and analyze registered and published clinical trials and observational studies for the pharmacological treatment of COVID-19 conducted in China. Methods: A strategic search was conducted via the Chinese Clinical Trial Registry to identify and extract clinical trials and observational studies registered and conducted in China for the pharmacological treatment of COVID-2019 between January 1st, 2020 and March 21st, 2020. This was further supplemented by searches conducted via the China National Knowledge Infrastructure (CNKI) database, the MEDLINE database, the World Health Organization (WHO) database, and MedRxiv and BioRxiv electronic platforms for preprint articles, published up until April 8th, 2020. Studies available in Chinese and English were included in the searches and extracted. A primary descriptive analysis was performed for registered clinical trials and observational studies identified in the Chinese Clinical Trial Registry based on the extraction of the following clinical study information: trial ID, planned date of enrollment, recruitment status, study design, population, sample size, intervention/exposure group, control /reference group, dosage, and primary outcomes. A secondary descriptive analysis was performed for published clinical trials and observational studies identified from the supplementary databases based on the extraction of the following published clinical study information: study design, population, intervention/exposure group, control /reference group and main results as appropriate. Results: A total of 221 clinical trials and observational studies were included from all databases searched. From the Chinese Clinical Trial Registry, 195 registered clinical studies including 170 clinical trials and 25 observational studies were identified and included for primary analysis. From the supplementary databases, 26 published clinical studies including 8 clinical trials and 18 observational studies were included for secondary analysis. Of these 26 published clinical studies, 18 studies, including 3 clinical trials and 15 observational studies were identified from CNKI, 2 studies including 1 clinical trial and 1 observational study from MEDLINE, 2 including 1 clinical trials and 1 observational studies from the WHO database, and 4 including 3 clinical trials and 1 observational studies from MedRxiv and BioRxiv platforms. In the primary analysis, among the 170 clinical trials included from the Chinese Clinical Trial Registry, 101 investigated western medicines (WMs), while 15 investigated Traditional Chinese Medicines (TCMs), and 54 investigated a combination of TCMs and WMs. Among the 25 included observational studies from the Chinese Clinical Trial Registry, 2 investigated WMs, 2 investigated TCMs, and 21 investigated a combination of TCMs and WMs. The total number of exposed patients in all 195 clinical studies from the Chinese Clinical Trial Registry amounted to 24,500. In the secondary analysis, treatment with Lopinavir-ritonavir and treatment with Hydroxychloroquine was not associated with a difference from standard of care in the rate of RT-PCR negativity; treatment with a combination of Lopinavir-ritonavir, interferon α, and Lian-Hua-Qing-Wen capsule was found to significantly improve the effective rate of treatment compared with Interferon α combined with Lian-Hua-Qing-Wen capsule. Conclusions: China is generating a massive source of evidence that is critical for defeating the COVID-19 pandemic. Not only the clinical experience, but also the scientific evidence should be shared with the global scientific community.

Subject Areas

COVID-19; clinical studies; China; clinical trials; observational studies

Comments (1)

Comment 1
Received: 18 April 2020
Commenter: Ronald Conte
The commenter has declared there is no conflict of interests.
Comment: It seems possible, even likely, that the control arm of some studies in China might include use of Traditional Chinese Medicines. The "Handbook of COVID-19 Prevention and Treatment" (from The First Affiliated Hospital, Zhejiang University School of Medicine) lists several TCMs used as part of what appears to be standard care: "XII. TCM Classification Therapy to Improve Curative Efficacy". Since TCMs are not generally used in the West, especially when treating COVID-19, the usefulness of those studies and their results is called into question.
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