An evidence mapping and analysis of registered COVID-19 clinical trials in China

Abstract

Background: This article aims to summarize the key characteristics of registered trials of 2019 novel coronavirus (COVID-19), in terms of their spatial and temporal distributions, types of design and interventions, and patient characteristics among others. Methods: A comprehensive search of the registered COVID-19 trials has been performed on platforms including ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (WHO ICTRP), Chinese Clinical Trials Registry (CHiCTR), Australian Clinical Trials Registry, Britain's National Research Register (BNRR), Current Control Trials (CCT), and Glaxo Smith Kline Register. Trials registered at the first 8 weeks of the COVID-19 outbreak are included, without language restrictions. For each study, the registration information, study design, and administrator information are collected and summarized. Results: A total of 220 registered trials were evaluated as of February 27, 2020. Hospital-initiated trials were the majority and account for 80% of the sample. Among the trials, pilot studies and phase 4 trials are more common and represent 35% and 19.1% of the sample, respectively. The median sample size of the registered trials is 100, with interquartile range 60-240. Further, 45.9% of the trials mentioned information on a data monitoring committee. 54.5% of the trials did not specify the disease severity among patients they intend to recruit. Four types of interventions are most common in the experimental groups across the registered studies: antiviral drugs, Traditional Chinese Medicine (TCM), biological agents, and hormone drugs. Among them, the TCM and biological agents are frequently used in pilot study and correspond to a variety of primary endpoints. In contrast, trials with antiviral drugs have more targeted primary outcomes such as "COVID-19 nucleic acid test" and "28-day mortality." Conclusions: We provide an evidence mapping and analysis of registered COVID-19 clinical trials in China. In particular, it is critical for ongoing and future studies to refine their research hypothesis and better identify their intervention therapies and the corresponding primary outcomes. It is also imperative for multiple public health divisions and research institutions to work together for integrative clinical data capture and sharing, with a common objective of improving future studies that evaluate COVID-19 interventions.

COVID-19-related medical research: a meta-research and critical appraisal

“…More than ever, unproductive competition and opportunism should be avoided [ 20 , 34 ] to publish relevant, rigorous, and reliable research [ 39 ]. Collaborations should be promoted and systematic reviews with regular updates are also urgently required for the health practitioners to gain a comprehensive understanding of the issues concerned [ 5 , 33 , 40 , 41 ].…”

Effects of Tanreqing Capsule on the negative conversion time of nucleic acid in patients with COVID-19: A retrospective cohort study

“…TCM and biological agents are frequently used in registered COVID-19 clinical trials in China [8] . We have found that treatments that combine Chinese and Western medicine provide clues for managing COVID-19 patients in the Shanghai Public Health Clinical Center [9] .…”

Chloroquine and hydroxychloroquine for COVID‐19: Perspectives on their failure in repurposing

“…The global scientific response, although highly collaborative in spirit, appears fragmented and disorganized. This is perhaps best illustrated by premature enthusiastic response to early studies from China and France 28,29 followed by the study reported by Mehra et al 50 In an effort to find a therapeutic agent to fight COVID‐19, a large number of clinical trials have proliferated 84‐88 but these trials vary widely in their design, target population and its stratification, indication, exclusion criteria, sample size, drugs and their dosing regimen, duration of therapy and study endpoints. An analysis of 201 trials registered before 26 March this year concluded that a third of these exclude clinical endpoints, almost half were designed to recruit 100 patients or less and more than 70% were open label, thus limiting their long‐term usefulness 89 .…”