Dataset Information

Characteristics of COVID-19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov.

ABSTRACT:

Objective

This study aimed to evaluate the fundamental characteristics of coronavirus disease (COVID-19) clinical trials registered in China.

Methods

COVID-19 clinical trials registered in China were analyzed from databases on ChiCTR and ClinicalTrials.gov. The study designs, samples, primary end points, and intervention measures were evaluated.

Results

In total, 262 intervention clinical trials were retrieved on March 10, 2020. Overall, 181 (69.1%) trials involved two groups, 200 (76.3%) trials were randomized parallel trials, 24 (9.2%) trials were double blind, and 60.3% of trials included ≤100 participants. Sixty (22.9%) trials considered symptom improvement as the primary endpoint and 43 (16.4%) trials considered the rate or time at which the subjects became virus-free as the primary endpoint. Of 262 intervention studies, chemical drugs and biological products were studied in 105 (40.1%) intervention studies, of which antiviral drugs accounted for 15.3% and malaria drugs accounted for 8.4% of the studies. Among all trials, 27.9% of the studies used traditional Chinese medicine (TCM), 10.3% used cell therapy, and 5.0% used plasma therapy.

Conclusion

This study is the first snapshot of the landscape of COVID-19 clinical trials registered in China and provided the basic features of clinical trial designs for the treatment and prevention of COVID-19 to offer useful information to guide future clinical trials on COVID-19 in other countries.

SUBMITTER: Huang J

PROVIDER: S-EPMC7266821 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

Characteristics of COVID-19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov.

Huang Jihan J He Yingchun Y Su Qianmin Q Yang Juan J

Drug design, development and therapy 20200529

<h4>Objective</h4>This study aimed to evaluate the fundamental characteristics of coronavirus disease (COVID-19) clinical trials registered in China.<h4>Methods</h4>COVID-19 clinical trials registered in China were analyzed from databases on ChiCTR and ClinicalTrials.gov. The study designs, samples, primary end points, and intervention measures were evaluated.<h4>Results</h4>In total, 262 intervention clinical trials were retrieved on March 10, 2020. Overall, 181 (69.1%) trials involved two grou ...[more]

PMID: 32581514

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Project description:ObjectivesTo characterise current COVID-19-related research activities.DesignCross-sectional analysis.SettingClinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19.Data sourcesClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1 December 2019 and 1 May 2020 that test interventions related to the COVID-19 pandemic.Main outcome measuresWe classified trials according to intervention type, and report key trial characteristics including recruitment status, location, funder type, target enrolment number, intervention model (single group, randomised or sequential assignment) and projected completion date.ResultsOf the 630 identified clinical trials related to COVID-19, 509 (81%) involved the study of drugs or biological agents. Of these trials of drugs and biologics, 305 (60%) use an open-label design, 43 (8%) are single blinded (participant only) and 161 (32%) are double blinded (participant and investigator). 94 (18%) of the drug/biological trials are non-randomised. Either hydroxychloroquine or chloroquine is administered as part of the study protocol in 152 (30%) of the drug/biological trials. The total planned enrolment for these hydroxychloroquine/chloroquine trials is over 200 000 participants, which represents 65% of the total planned enrolment for all registered trials of drugs or biologics. There are also at least 25 registered trials of azithromycin (n=53), convalescent plasma (n=38), lopinavir/ritonavir (n=30), stem cell treatments (n=29) and tocilizumab (n=25). 142 trials were registered in the first 3 months of 2020, and 488 trials were registered between 1 April and 1 May 2020.ConclusionsThese findings demonstrate a robust research response to the COVID-19 pandemic, though many of the currently planned and ongoing trials focus on a small number of potential therapies, and many also lack essential design features and power necessary to provide accurate treatment effect estimates.

Project description:Objective: Clinical trials are the most effective method for evaluating therapeutic strategies. The purpose of this study was to comprehensively assess the characteristics of trials on lupus nephritis (LN) and provide a reference for LN treatment and research. Methods: Registered therapeutic trials on drug interventions for LN were obtained from ClinicalTrials.gov up to December 3, 2020. The general characteristics, methodological characteristics, detailed characteristics, investigated drugs, eligibility criteria, and outcome measures of these trials were analyzed. Results: A total of 126 eligible trials were evaluated, and these trials mainly investigated the initial treatment of adult proliferative LN. Half of the trials enrolled <50 participants, and 70.7% of the trials lasted for 6-24 months. In total, 95.2% of trials adopted an interventional study design. Of intervention trials, 56.6% were in phase 2 or phase 3, 76.7% were randomized, 77.5% employed a parallel assignment, and 41.7% were masked. The eligibility criteria and outcome measures of the included trials varied and involved a variety of indicators. Chemical agents and biologics are the most widely studied immunotherapies, of which mycophenolate mofetil, tacrolimus, and rituximab are the most studied. In addition, some trials studied cell transplantation treatment. Conclusions: The majority of clinical trials for LN therapy registered on ClinicalTrials.gov investigated the initial treatment of adult proliferative LN, and most of these trials were randomized, parallel assigned, and insufficiently masked interventional trials with small scale, short duration, various eligibility criteria, and outcome measures. We hope that more large-scale, long-term multicenter, and high-quality RCT trials with standardized inclusion criteria/exclusion criteria and treatment effect evaluation systems will be conducted and that more energy and funding will be put into exploring biological products and stem cell therapies. In addition, trials for membranous LN, childhood-onset LN, and maintenance phase LN are needed to establish optimal treatment strategies.

Project description:BackgroundDental caries, a widespread chronic oral disease, is caused by multiple factors including microorganisms, genetic predisposition. Despite being preventable, it poses a significant global burden. This study reviews all phase 4 clinical trials on dental caries registered at ClinicalTrials.gov to provide a comprehensive overview of their characteristics.MethodsA search was conducted on the ClinicalTrials.gov database using keywords. The registration data for all relevant phase 4 studies concerning 'Dental Caries' were retrieved. This search was conducted on the 23rd of January, 2024.ResultsThe analysis included 58 phase 4 clinical trials, with most studies (67.2%) reporting complete data. The majority (63.8%) had fewer than 100 participants, and the predominant sponsors were medical institutions (77.6%). Geographically, the highest percentage of studies were conducted in South America (24.1%), with the lowest in North America (10.3%). Interventional trials primarily focused on treatment (51.7%) and prevention (41.4%), with a significant portion being randomized (93.1%). Blinding varied, with single and double blinding each used in 25.9% of studies. Drug interventions were the most common (60.6%), followed by other categories such as dietary supplements and procedures. Among drug interventions, agents containing fluoride were the largest category, accounting for 52.6% of the trials. Fluoride varnishes and silver diamine fluoride were the most frequently evaluated. Sedatives and pain relievers constituted 15.7% of the trials, with midazolam and ketamine being predominant. Other drugs accounted for 23.2% of the trials, featuring diverse substances such as inactivated poliovirus vaccine and xylitol. Dental materials and operative treatments made up 29.5% of the trials, with resin and fissure sealants being the most commonly evaluated.ConclusionThis analysis of phase 4 clinical trials highlighted fluoride as the most studied intervention for dental caries prevention. The analysis also revealed a need for further research on non-fluoride interventions and emphasized the importance of using evidence-based practices in dental care for improved oral health outcomes.Clinical trial numberNot applicable.

Dataset Information

Characteristics of COVID-19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov.

Objective

Methods

Results

Conclusion

Publications

Characteristics of COVID-19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov.

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