Analysis of the WHO ICTRP for novel coronavirus clinical trial registrations.

Up-to-date information on the current progress made in the research and development to control the global COVID-19 pandemic is important. The study aimed to analyze the clinical trial characteristics and vaccine development progress of the new Coronavirus Disease 2019 (COVID-19) registered with the World Health Organization International Clinical Trial Registry Platform (WHO ICTRP).A comprehensive search of COVID-19 clinical trials since the establishment of the ICTRP to June 11, 2020, was conducted to record and analyze relevant characteristics. Chi-Squared test was used to compare the statistical differences between different research types, interventions, and sources.A total of 3282 COVID-19 clinical trials in 17 clinical trial registration centers were registered with the WHO ICTRP. The main research sources for the present study were ClinicalTrials.gov and ChiCTR. There were significant differences in the parameters of study location (P = .000), number of participants (P = .000), study duration (P = .001), research stage (P = .000), randomization procedure (P = .000), and blinding method (P = .000) between the 2 registration sources. There were significant differences in all the parameters between different kinds of intervention methods. Hydroxychloroquine, plasma therapy, and Xiyanping injection were the high-frequency research drugs used. Ten different vaccine studies were registered under phases I-II.Amongst the studies researched, heterogeneity existed for various parameters. Differences in the type of study, interventions, and registration sources of the studies led to significant differences in certain parameters of the COVID-19 clinical trials. The statistics of high-frequency drugs and the progress of vaccine trials may provide an informative reference for the prevention and control of COVID-19.

Advance of Novel Coronavirus Registration Clinical Trial (preprint)

Background.This research aims to analyze the clinical characteristics of a novel Corona Virus Disease (COVID-19) registered in the Chinese Clinical Trial Registry (ChiCTR), and to provide an information-based data foundation and information reference for curbing the spread of the COVID-19 epidemic. Methods.The ChiCTR database was comprehensively searched, and the COVID-19 research registration information as of February 24, 2020 was counted. Descriptive analysis of registration time trends and geographical distribution. Chi-square test was used to compare the statistical differences between different study types, intervention methods, research phases and major sponsors. Frequency studies were used to analyze the characteristics of CMT and BI therapy. Results.232 COVID-19 studies registered at the ChiCTR Center were collected. The overall number of COVID-19 registrations was increased. Hubei Province, China has the largest number of registrations, followed by Guangdong, Zhejiang and Sichuan. There were significant differences between the number of participants (P=0.000), study duration (P=0.008), study assignment (P=0.000), and blind method (P=0.000) for different study types. Significant differences could be seen in the dimensions of multicenter study(P=0.022), of participants numbe(P=0.000), study duration(P=0.000) and study assignment(P=0.001) for the four intervention methods. There were significant differences in study assignment (P=0.043) between the early and late studies. CMT drugs with high research frequency are chloroquine, lopinavir / ritonavir, and I-IFN, which are all in phase 4; BI was Cell therapy, plasma therapy, Thymosin, and M/P-AB, which are all in early stages. Conclusion.There were problems of unclear classification of research types and irregular registration behavior. Also, within the studies researched, heterogeneity exists for various dimensions. Different research types, intervention methods, and research stages lead to significant differences in some dimensions of the COVID-19 study. Finally, statistical high-frequency research drugs can provide more treatment options and evidence-based evidence for the clinical practice.