An interventional study of Multi-Agent Integrated Smart Toolkit for Emerging Infectious Diseases and Routine Practices in Emerging Infectious Diseases, COVID-19 and Influenza, sponsored by Peking University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Peking University · Not applicable, Interventional, and Prevention
Emerging infectious diseases, such as COVID-19, mpox, and dengue fever, are characterized by rapid transmission, wide impact, and high uncertainty, posing ongoing threats to global public health. While China achieved significant success in COVID-19 control, the response also revealed key challenges, including fragmented information, delayed risk perception, experience-dependent assessment, and inefficiencies in complex decision-making. This study aims to establish a smart technology system covering the full chain of "risk perception-situational assessment-intelligent decision-making-comprehensive evaluation." Specific objectives include: Constructing a global disease burden database and knowledge graph for emerging infectious diseases; Developing early risk assessment models covering the full transmission spectrum (cross-species, imported, and local outbreak); Building an AI-driven collective intelligence decision-support tool for epidemic control; Developing precise intervention frameworks and comprehensive evaluation indicators for key populations (e.g., elderly, students); Integrating the above technologies into a multi-agent toolkit and evaluating its effectiveness through a cluster randomized controlled trial involving at least 36 district/county-level CDC clusters across five provinces/municipalities (Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai).
Three eligible CDC staff members will be enrolled from each participating cluster, including one CDC director or relevant leader responsible for infectious disease prevention and control and two professional staff members engaged in acute infectious disease surveillance, risk assessment, decision-making, or emergency response. Accordingly, at least 108 participants will be enrolled, and the final anticipated enrollment will be determined by the total number of participating clusters.
The intervention group will use the smart toolkit alongside routine practices, while the control group will follow routine practices only. The primary outcome is response time for epidemic assessment and decision-making (hours from risk perception to decision completion). Secondary outcomes include epidemic control effectiveness, user satisfaction, and socioeconomic benefits. The intervention period is 3 months, starting around July 2026 and ending in December 2027. This study has been approved by the Peking University Biomedical Ethics Committee. The study does not involve individual patient data; all data are aggregated at the district/county level from CDC sources or publicly available data. Anonymous questionnaires do not collect any personal identifiable information.
This is a multicenter, cluster-randomized controlled trial (cRCT) with a single-blind design (blinding of statisticians). The study will be conducted across five provinces/municipalities: Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai. At least 36 district/county-level Centers for Disease Control and Prevention (CDCs) will be selected as study clusters and allocated in an approximately 1:1 ratio to either the intervention group or the control group. Three eligible CDC staff members will be enrolled from each participating cluster, including one CDC director or relevant leader responsible for infectious disease prevention and control and two professional staff members engaged in acute infectious disease surveillance, risk assessment, decision-making, or emergency response.
Randomization Procedure: For the four provinces (Zhejiang, Guangdong, Hubei, and Sichuan), participating district/county-level CDC clusters will be stratified within each province according to socioeconomic level (high, medium, and low), as applicable, and randomly allocated within strata to the intervention or control group. For Shanghai municipality, participating district-level CDC clusters will be stratified by urban functional zone (central urban vs. new/suburban districts) and randomly allocated within strata. Cluster allocation will be maintained in an approximately 1:1 ratio.
Intervention: The intervention group will use a multi-agent integrated toolkit (including data-knowledge agent, assessment agent, decision agent, and evaluation agent) to assist with epidemic risk perception, situational assessment, and emergency decision-making, in addition to routine practices. The control group will follow routine practices only.
Follow-up Plan: The intervention period is 3 months, timed to coincide with peak seasons for specific infectious diseases (winter/spring for respiratory infections; summer/autumn for vector-borne diseases like dengue). Follow-up assessments will occur every 3 months, with the endpoint defined as the conclusion of an emerging infectious disease event.
Sample Size: Using PASS software (two-sided α=0.05, Power=80%, ICC=0.05, CV=0.5, standard deviation=12 hours, and average cluster size m=3), and assuming a 30% reduction in response time in the intervention group, a minimum of 32 evaluable clusters, corresponding to 16 clusters per group and 96 evaluable participants, is required. Because only 3 participants will be enrolled from each cluster and an individual attrition rate of approximately 10% is anticipated, at least 36 clusters and at least 108 participants will be recruited. The final anticipated enrollment will equal three times the actual number of participating clusters.
Data Management: Dual independent data entry will be performed. Data will be stored on Peking University's encrypted servers, with backups on the university cloud platform and offline encrypted hard drives (AES-256 encryption). All data will be physically destroyed after the retention period.
Missing Data: Analysis will follow the intention-to-treat (ITT) principle. Missing primary outcome data will be handled using the last observation carried forward (LOCF) method.
Safety Evaluation: Adverse events include headache and absenteeism, classified using a five-level attribution scale (definitely, probably, possibly, probably not, definitely not related), with the first three categories counted as adverse reaction rates. Any serious adverse event must be reported immediately to the sponsor and/or ethics committee.
Early Termination: The study may be terminated early under the following conditions: (1) identification of serious safety issues; (2) the toolkit proves ineffective or futile; (3) major protocol flaws or implementation deviations; (4) request by the applicant or administrative authority.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 108 is close to the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Peking University is the lead sponsor of 419 studies on the registry; 123 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive the multi-agent integrated smart toolkit, consisting of Data-Knowledge, Assessment, Decision, and Evaluation agents, in addition to routine infectious disease prevention and control practices. The toolkit is designed to assist CDC staff with epidemic risk perception, situational assessment, and emergency decision-making throughout the 3-month intervention period, alongside their routine CDC workflow.
Other: Multi-Agent Integrated Smart Toolkit for Emerging Infectious Diseases
Participants in this arm will follow routine infectious disease prevention and control practices only, without access to the multi-agent integrated smart toolkit, including standard epidemic surveillance, information collection, risk assessment, and emergency response procedures currently implemented at their respective CDC, and will continue their regular workflow without any additional intervention during the 3-month study period.
Other: Routine Practices
The multi-agent integrated smart toolkit consists of four integrated agents: (1) Data-Knowledge Agent - for early risk perception based on historical event experience; (2) Assessment Agent - for risk assessment and situational analysis; (3) Decision Agent - for emergency decision support; and (4) Evaluation Agent - for effect simulation and comprehensive evaluation. The toolkit is designed to assist CDC staff with epidemic risk perception, situational assessment, and emergency decision-making. It is used alongside routine infectious disease prevention and control practices.
Also known as: SMART-ID Toolkit
Routine infectious disease prevention and control practices currently implemented at the CDC, including standard epidemic surveillance, information collection, risk assessment, and emergency response procedures.
Response Time for Risk Assessment Report Generation and Submission
Response time consists of two components measured in hours: (1) Report generation time - time from the diagnosis of the index case in a cluster outbreak to the system's automatic generation of the first risk assessment report and decision-support recommendations; and (2) Report submission time - time from report generation to its official submission. Measured via electronic questionnaire and CDC reporting logs.
Time frame: Measured at baseline (enrollment) and at the end of the 3-month intervention period
Consistency of Risk Assessment Results between Multi-Agent Toolkit and Expert Panel
Measured by the level of agreement (including risk level classification) between the risk assessment outcomes generated by the multi-agent toolkit and those produced by an independent expert panel. Assessed via comparison of risk reports generated during outbreak events.
Time frame: Assessed at the end of the 3-month intervention period
Epidemic Control Effectiveness
Measured by: (1) duration of each cluster outbreak (days from the first case to the last case); and (2) number of secondary cases generated during the outbreak period. Data are derived from routine surveillance systems and epidemiological investigation reports (de-identified, aggregated data only).
Time frame: Assessed continuously throughout the 3-month intervention period and summarized at the end of the intervention
User Experience and Satisfaction with the Smart Toolkit
Quantitative evaluation via electronic questionnaire measuring overall user acceptance and integration of the tool among participating CDC staff. Three subscales (user satisfaction, perceived usefulness, and workflow integration) will be assessed, each scored on a Likert scale. The total score will be calculated as the mean of the three subscale scores, ranging from 1 to 5, with higher scores indicating greater overall acceptance and integration.
Time frame: Measured at the end of the 3-month intervention period
Healthcare Resource Consumption
Assessment of healthcare resource consumption associated with the intervention, measured in monetary value (local currency, CNY), evaluated through Difference-in-Differences (DID) models.
Time frame: Assessed at the end of the 3-month intervention period
Prevention and Control Resource Inputs
Assessment of resource inputs for prevention and control activities, measured in monetary value (local currency, CNY), evaluated through Difference-in-Differences (DID) models.
Time frame: Assessed at the end of the 3-month intervention period
Reduction in Hospitalization Burden
Assessment of the reduction in hospitalization burden attributable to the intervention, measured as the number of hospitalizations avoided, evaluated through Markov decision tree models.
Time frame: Assessed at the end of the 3-month intervention period
Reduction in Severe Disease Burden
Assessment of the reduction in severe disease burden attributable to the intervention, measured as the number of severe cases avoided, evaluated through Markov decision tree models.
Time frame: Assessed at the end of the 3-month intervention period
Cost-Effectiveness Ratio
Assessment of the cost-effectiveness of the intervention, measured as cost per quality-adjusted life year (QALY) gained or cost per disability-adjusted life year (DALY) averted, evaluated through Markov decision tree models.
Time frame: Assessed at the end of the 3-month intervention period
Macroeconomic Impact
Assessment of the broader macroeconomic impact of the intervention, measured as percentage change in GDP or monetary value in local currency, evaluated through Computable General Equilibrium (CGE) models.
Time frame: Assessed at the end of the 3-month intervention period
Started Aug 2026 (actual). Primary completion is estimated for Jul 2027, 11 months after the start.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's planned 11 months is above that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
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