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Quality Assessment of the Clinical Trial Protocols Regarding Treatments for Coronavirus Disease 2019

17 Pages Posted: 24 Mar 2020

See all articles by Jiaxing Zhang

Jiaxing Zhang

Guizhou Provincial People's Hospital - Department of Pharmacy

Yiling Lu

The Third People’s Hospital of Chengdu, Department of Pharmacy

Joey Kwong

St. Luke’s International University - Global Health Nursing

Xiaosi Li

Hospital of Chengdu Office of People’s Government of Tibetan Autonomous Region - Department of Pharmacy

Wenyi Zheng

Karolinska Institutet - Experimental Cancer Medicine

Rui He

Karolinska Institutet - Experimental Cancer Medicine

More...

Abstract

Background: With the global spread of coronavirus disease 2019 (COVID-19), an increasing number of clinical trials are being designed and executed to evaluate the efficacy and safety of various therapies for COVID-19. We conducted this survey to assess the methodological quality of registry protocols on potential treatments for COVID-19.

Methods: Clinical trial protocols were identified on the ClinicalTrials.gov and the Chinese Clinical Trial Registry. Protocols were screened by two investigators independently against pre-defined eligibility criteria. Quality of the included protocols was assessed according to the modified 14-item SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement.

Findings: We included 82 randomized controlled trial (RCT) protocols investigating treatment modalities for COVID-19. These ongoing trials are being conducted in 16 provinces, autonomous regions, and municipalities of China, and study interventions were either Western medicines (n=56) or traditional Chinese medicine (n=26). Findings of our quality assessment indicated that the existing trial protocols could be further improved on several aspects, including selection and definition of outcome measures, descriptions of study interventions and comparators, study subject recruitment time, definition of study inclusion and exclusion criteria, and allocation concealment methods. Descriptions of random sequence generation methodologies were accurate for the majority of included trial protocols (n=64; 78·05%); however, reporting of allocation concealment remained unclear in 63 (76·83%) protocols. Therefore, the overall risk of selection bias across these RCTs was judged to be unclear. A total of 52 (63·41%) included RCT protocols were open-label trials and are thus associated with a high risk of performance bias and detection bias.

Interpretation: Quality of currently available RCT protocols on the treatments for COVID-19 could be further improved. For transparency and effective knowledge translation in real-world clinically settings, it is important for trial investigators to standardize baseline treatments for patients with COVID-19 and assess clinically important core outcome measures. Despite eager anticipation from the public on the results of effectiveness trials in COVID-19, robust design, execution and reporting of these trials should be regarded as high priority.

Funding Statement: The authors received no specific funding for this work.

Declaration of Interests: All authors declare no competing interests.

Keywords: 2019 Novel Coronavirus; coronavirus disease 2019; Randomized Controlled Trial Protocol

Suggested Citation

Zhang, Jiaxing and Lu, Yiling and Kwong, Joey and Li, Xiaosi and Zheng, Wenyi and He, Rui, Quality Assessment of the Clinical Trial Protocols Regarding Treatments for Coronavirus Disease 2019 (3/10/2020). Available at SSRN: https://ssrn.com/abstract=3552834 or http://dx.doi.org/10.2139/ssrn.3552834

Jiaxing Zhang

Guizhou Provincial People's Hospital - Department of Pharmacy ( email )

China

Yiling Lu

The Third People’s Hospital of Chengdu, Department of Pharmacy ( email )

China

Joey Kwong

St. Luke’s International University - Global Health Nursing ( email )

Tokyo
Japan

Xiaosi Li (Contact Author)

Hospital of Chengdu Office of People’s Government of Tibetan Autonomous Region - Department of Pharmacy ( email )

China

Wenyi Zheng

Karolinska Institutet - Experimental Cancer Medicine ( email )

Stockholm
Sweden

Rui He

Karolinska Institutet - Experimental Cancer Medicine ( email )

Stockholm
Sweden

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