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\begin{document}

\title{Clinical trials should focus on quality: an investigation into the
registration of clinical trials of COVID-19}



\author[1]{Xinqi Teng}%
\author[1]{Tingting Qi}%
\author[1]{Guohua Li}%
\author[1]{Jiaojiao Wang}%
\author[1]{Qiang Qu}%
\author[1]{Yali Wu}%
\author[1]{Qiong Lu}%
\author[1]{Jian Qu}%
\affil[1]{Affiliation not available}%


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  \date{May 20, 2024}


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\begin{abstract}
Background: The coronavirus disease 2019 (COVID-19) is threatening the
lives and health of people all over the world since its outbreak in
Wuhan, Hubei province, China. Up to now, thousands of clinical trials
have been registered, but there are still no effective and specific
drugs for COVID-19 treatment. Large randomized controlled clinical
trials face many challenges and the quality of COVID-19 clinical trials
is also worrying. Methods: We searched all the COVID-19 clinical trials
registered on the Chinese Clinical Trials Registry and
ClinicalTrials.gov on June 29, 2020. Then we extracted the basic
information of these COVID-19 clinical trials and analyzed the current
dilemma of clinical trials of COVID-19. Results: A total of 3021 studies
were retrieved, including 665 trials from the Chinese Clinical Trial
Registry and 2356 trials from ClinicalTrials.gov. Among these clinical
trials, 293 and 1314 intervention studies were registered in the Chinese
Clinical Trial Registry and ClinicalTrials.gov, respectively. Up to now,
only 4.48\% of these intervention trials have completed their
recruitment, and there were still 11.60\% of studies registered in the
Chinese Clinical Trials Registry have not yet been approved by the
ethics committee. Phase II and phase III studies that could prove the
safety and effectiveness of drugs accounted for 42.25\%. The median and
interquartile range (IQR) of sample size was 100 (60, 200) and 384 (50,
120) in the Chinese Clinical Trial Registry and ClinicalTrials.gov,
respectively. The number of randomized controlled trials (RCTs) were
rare, and 50.71\% of these studies were open-label. Conclusions: The
quality of COVID-19 clinical trials that have been registered was low,
and no reliable results have been published due to the design
deficiency. Well-designed and cooperative trials are urgently needed to
defeat the COVID-19 epidemic.%
\end{abstract}%



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