The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, coronavirus disease 2019 (COVID-19), affecting more than seventeen million people around the world. Diagnosis and treatment guidelines for clinicians caring for patients are needed. In the early stage, we have issued "A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version)"; now there are many direct evidences emerged and may change some of previous recommendations and it is ripe for develop an evidence-based guideline. We formed a working group of clinical experts and methodologists. The steering group members proposed 29 questions that are relevant to the
Background: Since the outbreak of coronavirus diseases 2019 (COVID-19), many researchers in China have immediately carried out clinical research scheme of the COVID-19. But, there is still a lack of systematic review of registered clinical trials. Therefore, we made the first systematic review of the clinical trials of COVID-19 in order to provide evidence for the control of the COVID-19. Methods: The database from the Chinese Clinical Registration Center and the ClinicalTrials.gov were searched to collect the registered clinical trials of COVID-19. The retrieval inception date is February 9, 2020. Two evaluators independently selected literature, extracted data and evaluated the risk of bias. This study is based on the recommendations of PRISMA in Cochrane handbook. Results: A total of 75 COVID-19 registered clinical trials (63 interventional studies and 12 observational studies) were obtained. 97.3% of clinical trials were initiated by Chinese organizations. Only 11 trials have begun to recruit patients, and all registered clinical trials have not been completed. Most of the trials are early clinical exploratory trials or in pre-experiment stage (only two trials of Remdesivir in Ⅲ stage), and the sample size of subjects recruited is small. The main intervention methods include traditional Chinese medicine treatment, western medicine treatment and integrated Chinese and Western medicine treatment. The subjects were mainly non severe adult patients (≥ 18 years old). The main outcomes were clinical observation and examination. The duration of most trials was more than 5 months, and the median of the intervention study was 180 d (95% CI: 146.3 -328.9 d); the median of the observation period was 334 d (95% CI: 166.6 -363.4 d). Overall, both the methodology quality of intervention register trials and observational trials are low. Conclusions: Disorderly and intensive clinical trialsof COVID-19 using traditional Chinese medicine and Western medicine are ongoing or will be carried out in China. However, based on the poor quality and small sample size and long completion period, we will not be able to obtain reliable, high-quality clinical evidence about COVID-19 treatment for quite a long time in the future. Improving the quality of study design, prioritizing promising drugs, and using different designs and statistical methods are worth advocating and recommending for the clinical trials of COVID-19 in China.
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